A Phase 3, Multicenter, Open-label, Single-arm, Extension Study to Evaluate the Long-term Safety and Tolerability of Cenerimod in Adult Subjects With Moderate-to-Severe Systemic Lupus Erythematosus (SLE) on Top of Background Therapy

The goal of this clinical study is to learn about the long-term safety and tolerability of cenerimod in adult patients with moderate to severe symptoms of systemic lupus erythematosus.
The main questions it aims to answer are:
* Whether cenerimod causes any adverse effects ('side effects') when given on top of drugs already being given for systemic lupus erythematosus.
* How well cenerimod works to reduce symptoms of systemic lupus erythematosus when taken for at least 1 year and up to 3 years.
Participants taking part in this study will have already taken part in another study, where they received either cenerimod or placebo (look-alike substance containing no active drug) for 1 year.
In this clinical study approximately 680 participants will receive cenerimod (on top of drugs already being given for systemic lupus erythematosus) for at least 1 year and up to 3 years.

Start Date30 Jul 2024

Sponsor / Collaborator

Idorsia Pharmaceuticals Ltd.

NCT05672576 / RecruitingPhase 3

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Adult Subjects With Moderate-to-severe Systemic Lupus Erythematosus (SLE) on Top of Background Therapy

The goal of this clinical trial is to see how well cenerimod reduces symptoms of Systemic Lupus Erythematous in adult patients with moderate to severe symptoms. The main questions it aims to answer are:
* How well cenerimod works on top of the treatment already being administered.
* How safe cenerimod is for adult patients with Systemic Lupus Erythematosus.
Researchers will compare one dose of cenerimod and a placebo to see how well cenerimod works when it is added to the treatment already being administered.
In this research study approximately 210 participants will receive cenerimod and approximately 210 participants will receive placebo for 12 months.

Start Date26 Jun 2023

Sponsor / Collaborator

Idorsia Pharmaceuticals Ltd.

NCT05648500 / RecruitingPhase 3

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Adult Subjects With Moderate-to-Severe Systemic Lupus Erythematosus (SLE) on Top of Background Therapy

The goal of this clinical trial is to see how well cenerimod reduces symptoms of Systemic Lupus Erythematosus in adult patients with moderate to severe symptoms. The main questions it aims to answer are:
* How well cenerimod works on top of the treatment already being administered.
* How safe cenerimod is for adult patients with Systemic Lupus Erythematosus.
Researchers will compare one dose of cenerimod and a placebo to see how well cenerimod works when it is added to the treatment already being administered.
In this research study approximately 210 participants will receive cenerimod and approximately 210 participants will receive placebo for 12 months.

Start Date13 Dec 2022

Sponsor / Collaborator

Idorsia Pharmaceuticals Ltd.

100 Clinical Results associated with Cenerimod

100 Translational Medicine associated with Cenerimod

100 Patents (Medical) associated with Cenerimod

Literatures (Medical) associated with Cenerimod

01 Jun 2021·DrugsQ1 · MEDICINE

Targeting Sphingosine-1-Phosphate Signaling in Immune-Mediated Diseases: Beyond Multiple Sclerosis

Q1 · MEDICINE

Review

Author: Pérez-Jeldres, Tamara ; Rivera-Nieves, Jesús ; Alvarez-Lobos, Manuel

Sphingosine-1-phosphate (S1P) is a bioactive lipid metabolite that exerts its actions by engaging 5 G-protein-coupled receptors (S1PR1-S1PR5). S1P receptors are involved in several cellular and physiological events, including lymphocyte/hematopoietic cell trafficking. An S1P gradient (low in tissues, high in blood), maintained by synthetic and degradative enzymes, regulates lymphocyte trafficking. Because lymphocytes live long (which is critical for adaptive immunity) and recirculate thousands of times, the S1P-S1PR pathway is involved in the pathogenesis of immune-mediated diseases. The S1PR1 modulators lead to receptor internalization, subsequent ubiquitination, and proteasome degradation, which renders lymphocytes incapable of following the S1P gradient and prevents their access to inflammation sites. These drugs might also block lymphocyte egress from lymph nodes by inhibiting transendothelial migration. Targeting S1PRs as a therapeutic strategy was first employed for multiple sclerosis (MS), and four S1P modulators (fingolimod, siponimod, ozanimod, and ponesimod) are currently approved for its treatment. New S1PR modulators are under clinical development for MS, and their uses are being evaluated to treat other immune-mediated diseases, including inflammatory bowel disease (IBD), rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and psoriasis. A clinical trial in patients with COVID-19 treated with ozanimod is ongoing. Ozanimod and etrasimod have shown promising results in IBD; while in phase 2 clinical trials, ponesimod has shown improvement in 77% of the patients with psoriasis. Cenerimod and amiselimod have been tested in SLE patients. Fingolimod, etrasimod, and IMMH001 have shown efficacy in RA preclinical studies. Concerns relating to S1PR modulators are leukopenia, anemia, transaminase elevation, macular edema, teratogenicity, pulmonary disorders, infections, and cardiovascular events. Furthermore, S1PR modulators exhibit different pharmacokinetics; a well-established first-dose event associated with S1PR modulators can be mitigated by gradual up-titration. In conclusion, S1P modulators represent a novel and promising therapeutic strategy for immune-mediated diseases.

01 Jan 2021·The Journal of Clinical PharmacologyQ3 · MEDICINE

Estimation of Attainment of Steady‐State Conditions for Compounds With a Long Half‐Life

Q3 · MEDICINE

Review

Author: Dingemanse, Jasper ; Krause, Andreas ; Lott, Dominik

AbstractHalf‐life is a standard result reported with analysis of pharmacokinetic data. Different definitions such as noncompartmental half‐life, terminal half‐life, effective half‐life, and context‐sensitive half‐life can yield substantially different estimates of the quantity “half‐life.” Time to attainment of steady‐state conditions is generally derived from (terminal) half‐life and therefore sensitive toward the definition of half‐life. Thus, estimates of the time to attain steady state must be provided with a precise definition of steady state and the method used for estimation, particularly for drugs with long (terminal) half‐life. For clinical purposes, terminal half‐life can have limited relevance if drug concentrations in the terminal elimination phase are low. A general rule for which half‐life to use is infeasible. While limited accumulation can be negligible if a plateau in pharmacokinetics/pharmacodynamics is reached or with a wide therapeutic window (ie, exposure range), small additional drug accumulation can be highly relevant for drugs with a narrow therapeutic window. Beyond the average, estimation of individual time to attainment of steady state can add highly relevant information about the variability between subjects. Simulations from population models and the use of different definitions of steady state provide an assessment of robustness of the results. The relevance of accurate estimation of time to attainment of steady state is illustrated with cenerimod, an sphingosine‐1‐phosphate 1 receptor modulator with long half‐life currently in clinical development for which estimates of time to steady state ranged from 35 to 110 days with different calculations.

01 Jan 2021·Clinical and Translational ScienceQ3 · MEDICINE

Pharmacokinetics and Pharmacodynamics of Cenerimod, A Selective S1P₁R Modulator, Are Not Affected by Ethnicity in Healthy Asian and White Subjects

Q3 · MEDICINE

ArticleOA

Author: Dingemanse, Jasper ; Ufer, Mike ; Winkle, Peter ; Juif, Pierre‐Eric

Cenerimod is a sphingosine‐1‐phosphate 1 receptor (S1P1R) modulator in phase II development for treatment of systemic lupus erythematosus. Its pharmacokinetics (PKs), pharmacodynamics (PDs), as well as safety and tolerability were investigated in white and Asian subjects to allow for recruitment of Asian patients in future studies. A randomized, double‐blind, placebo‐controlled parallel‐group study was performed in 20 healthy male subjects (n = 10 per ethnicity). A single, oral dose of 4 mg cenerimod or placebo (ratio 8:2) was administered under fasted conditions. The PKs of cenerimod were similar in white and Asian subjects indicated by geometric mean ratios (90% confidence interval) of 0.99 (0.80–1.21) for maximum plasma concentration, 0.96 (0.75–1.24) for area under the plasma concentration‐time curve from 0 to infinity, and 1.04 (0.86–1.25) for terminal half‐life. Accordingly, the extent and time course of reduction in lymphocyte count (as PD biomarker) were also similar in white and Asian subjects as compared with placebo. As observed for other S1PR modulators, a transient mean (SD) heart rate reduction in white (15.1 (14.8) bpm) and Asian (11.8 (6.16) bpm) subjects was observed following administration of cenerimod. The drug was safe and well‐tolerated indicated by occurrence of a single adverse event of chemical conjunctivitis in a white subject that was not suspected as study drug related. In conclusion, the determined absence of any relevant PK or PD differences supports using the same doses of cenerimod in white and Asian patients in upcoming late‐phase studies.

News (Medical) associated with Cenerimod

29 Oct 2024

·www.globenewswire.com

Idorsia announces financial results for the first nine months of 2024

Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland – October 29, 2024 Idorsia Ltd (SIX: IDIA) today announced its financial results for the first nine months of 2024. Highlights Net revenue 9M 2024 at CHF 53 million.US GAAP operating loss 9M 2024 of CHF 154 million and Non-GAAP operating loss of CHF 248 million.Improved Guidance for 2024, driven by diligent cost control.QUVIVIQ™ (daridorexant) total net sales of CHF 39 million in 9M 2024.Commercial partnership for QUVIVIQ with Menarini France.QUVIVIQ approved for the treatment of insomnia in Japan.TRYVIO™ (aprocitentan) commercially available in the US since October 2024.JERAYGO™ (aprocitentan) approved by the European Commission in June 2024 and marketing authorization applications submitted in the UK, Canada, and Switzerland.Collaboration with Neurocrine Biosciences comes to an end. André C. Muller, Chief Executive Officer of Idorsia, commented:“The one thing everyone wants to hear about – both internally and externally – is the status of a deal with aprocitentan. I’m pleased to share that our efforts on this front are advancing well. Our improved financial guidance includes our cost-conscious attitude across the whole organization, without compromising advancements, such as making progress in ramping up sales of QUVIVIQ, making TRYVIO available in the US, and expanding marketing authorization for JERAYGO.” Financial results US GAAP resultsNine MonthsThird Quarterin CHF millions, except EPS (CHF) and number of shares (millions)2024202320242023Net revenues531312680Operating expenses(211)(275)(118)150Operating income (loss)(154)(144)(90)231Net income (loss)(180)(181)(101)224Basic EPS(1.00)(1.02)(0.55)1.26Basic weighted average number of shares180.5178.2182.4178.4Diluted EPS(1.00)(1.02)(0.55)0.96Diluted weighted average number of shares180.5178.2182.4232.5 Net revenue of CHF 53 million in the first nine months of 2024 is the result of QUVIVIQ product sales (CHF 39 million), product sales to partners in the Asia-Pacific-Region (CHF 9 million) and contract revenue recognized in connection with Owkin (CHF 3 million). This compares to CHF 131 million in the first nine months of 2023, which included CHF 34 million sales of PIVLAZ in Japan (assigned in the meantime to Nxera Pharma as part of a transaction, more details can be found in the dedicated press release) and CHF 68 million one-off impact of the Nxera deal as well as CHF 4 million revenue share from Johnson & Johnson related to ponesimod sales (revenue-sharing agreement now eliminated as part of the reacquisition of aprocitentan, more details can be found in the dedicated press release). US GAAP operating expenses in the first nine months of 2024 benefited from extraordinary income of CHF 125 million from the Viatris deal resulting in an expense of CHF 211 million (CHF 275 million in the first nine months of 2023), of which CHF 16 million related to cost of sales (CHF 7 million in the first nine months of 2023), CHF 111 million to R&D expenses (CHF 235 million in the first nine months of 2023), and CHF 209 million to SG&A expenses (CHF 318 million in the first nine months of 2023). US GAAP net loss in the first nine months of 2024 amounted to CHF 180 million (CHF 181 million net loss in the first nine months of 2023). The net loss was favorably impacted by a one-off income related to the Viatris deal of CHF 125 million (CHF 302 million one-off income related to the Nxera deal in the first nine months of 2023) and lower operating expenses throughout all functions. The US GAAP net loss resulted in a basic net loss per share of CHF 1.00 (basic and diluted) in the first nine months of 2024, compared to a net loss per share of CHF 1.02 (basic and diluted) in the first nine months of 2023. Non-GAAP* measuresNine MonthsThird Quarterin CHF millions, except EPS (CHF) and number of shares (millions)2024202320242023Net revenues531312680Operating expenses(305)(517)(106)(124)Operating income (loss)(248)(386)(78)(44)Net income (loss)(258)(420)(75)(51)Basic EPS(1.43)(2.36)(0.41)(0.29)Basic weighted average number of shares180.5178.2182.4178.4Diluted EPS(1.43)(2.36)(0.41)(0.29)Diluted weighted average number of shares180.5178.2182.4178.4 * Idorsia measures, reports, and issues guidance on non-GAAP operating performance. Idorsia believes that these non-GAAP financial measurements more accurately reflect the underlying business performance and therefore provide useful supplementary information to investors. These non-GAAP measures are reported in addition to, not as a substitute for, US GAAP financial performance. Non-GAAP net loss in the first nine months of 2024 amounted to CHF 258 million: the CHF 78 million difference versus US GAAP net loss was mainly due to the one-off effect of the Viatris deal (CHF 125 million income), depreciation and amortization (CHF 14 million), share-based compensation (CHF 17 million) and a consent fee paid in shares to the bondholders resulting from amended terms of the 2024 convertible bonds (CHF 14 million). The non-GAAP net loss resulted in a net loss per share of CHF 1.43 (basic and diluted) in the first nine months of 2024, compared to a net loss per share of CHF 2.36 (basic and diluted) in the first nine months of 2023. Viatris collaborationIn March 2024, Idorsia closed agreements with Viatris Inc. (NASDAQ: VTRS), a global healthcare company, for collaboration on the global development and commercialization of two Phase 3 assets – selatogrel and cenerimod – with Idorsia receiving an upfront payment of USD 350 million, and the right to potential development and regulatory milestone payments of up to USD 300 million, potential sales milestone payments of up to USD 2.1 billion, and potential contingent tiered royalties from mid-single- to low-double-digit percentage on annual net sales. A joint development committee is overseeing the development of the ongoing Phase 3 programs for selatogrel and cenerimod up to regulatory approval. Idorsia will contribute up to USD 200 million in the next 3 years and transferred the dedicated personnel for both programs to Viatris. Viatris has worldwide commercialization rights for both selatogrel and cenerimod (excluding, for cenerimod only, Japan, South Korea, and certain countries in the Asia-Pacific region). Idorsia has also granted Viatris a right of first refusal and first negotiation for certain other pipeline assets. Convertible bonds 2024In July 2018, the Group issued CHF 200 million of senior unsecured convertible bonds (ISIN: CH0426820350), which were due to mature on July 17, 2024. On May 6, 2024, a bondholder meeting was held, where 83.5% of the total outstanding bondholders voted in favor of amendments to the terms of the bonds. The approved bond terms include an amended conversion price of CHF 6.00, extended maturity date of January 17, 2025, and the option to call the bonds at par, in full or in part, at any time upon giving ten trading days' notice. A consent fee of 8,000 shares per Bond was paid to bondholders on September 5, 2024. Financial outlook 2024For 2024 – excluding unforeseen events – the company expects QUVIVIQ net sales of around CHF 55 million; SG&A expenses of around CHF 265 million; R&D expense of around CHF 130 million for Idorsia-led pipeline assets; non-GAAP operating expenses around CHF 400 million. This performance would result in a non-GAAP operating loss of around CHF 350 million (excluding contract revenues and the one-off benefit from the Viatris deal). The company expects US GAAP operating loss for 2024 to reach CHF 260 million which includes a one-off benefit of CHF 125 million from the Viatris deal. Arno Groenewoud, Chief Financial Officer, commented:“While closing a deal for TRYVIO is a key focal point, we have also sharpened our cost-conscious approach, which we will increase going forward. Hence, we have been able to stretch the cash runway out to about year-end 2024, which allows us to appropriately plan and execute the next steps of our financial strategy. Furthermore, as a result of lower than expected spending we can upgrade our US GAAP and non-GAAP operating loss guidance by around 60 million Swiss francs each, taking them to 260 million and 350 million Swiss francs, respectively.” Liquidity and indebtednessAt the end of the first nine months of 2024, Idorsia’s liquidity amounted to CHF 92 million. (in CHF millions)Sep 30, 2024Jun 30, 2024Dec 31, 2023Liquidity Cash and cash equivalents92237145Total liquidity*92237145 Indebtedness Convertible loan335335335Convertible bond797797796Other financial debt162162162Total indebtedness1,2941,2941,293 *rounding differences may occur Commercial operationsIn the first nine months of 2024, QUVIVIQ™ (daridorexant) in the US, Germany, Italy, Switzerland, Spain, UK, Canada, Austria, and France generated total product sales of CHF 39 million. United States ProductMechanism of actionIndicationCommercially available sinceDual orexin receptor antagonistTreatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenanceMay 2022 In the US, net sales of QUVIVIQ® (daridorexant) in the first nine months of 2024 reached CHF 21 million, an increase of +41% versus the first nine months of 2023. As of the end of the third quarter 2024, more than 165,000 patients have been treated with QUVIVIQ since launch in the US, over 500,000 prescriptions have been dispensed, and the product has been prescribed by almost 50,000 healthcare professionals. Tosh Butt, President, and General Manager of Idorsia US, commented:“Due to budget constraints we have recently reduced our field force for QUVIVIQ. Despite the reduction, the sales are holding-up for now. Importantly, the citizen petition requesting a review of the evidence from available data, which will hopefully lead to the descheduling of the DORA class of chronic insomnia medications, continues to make progress.” For more information about QUVIVIQ in the US, see the Full Prescribing Information (PI and Medication Guide). ProductMechanism of actionIndicationCommercially available sinceDual endothelin receptor antagonistTreatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugsOctober 2024 On March 19, 2024, the US Food and Drug Administration (FDA) approved TRYVIO™ (aprocitentan) for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. The recommended dosage of TRYVIO is 12.5 mg orally once daily, with or without food. Tosh Butt concluded:“Idorsia is making robust progress with the preparation of everything required for a full commercial launch of TRYVIO by the end of the first quarter of 2025. Both the REMS program and specialty distribution channel are fully up and running, we have begun engaging with hypertension experts through our presence at major cardiovascular and nephrology congresses. The initial discussions with payors are also encouraging. TRYVIO is now available to prescribe to the millions of patients in the US whose high blood pressure is not adequately controlled by other drugs. We have everything in place except a field-force and funding for promotional activities, which is dependent on a partnership deal.” Further details on the approval, together with commentary from company management can be found in the dedicated press release and investor webcast available from the company corporate website. For more information see the Full Prescribing Information including BOXED Warning (PI and Medication Guide). Europe and Canada ProductMechanism of actionIndicationCommercially availableDual orexin receptor antagonistTreatment of adult patients with insomnia characterised by symptoms present for at least three months and considerable impact on daytime functioningSweden: Sept. 2024France: Mar. 2024Austria: Feb. 2024UK: Oct. 2023Spain: Sept. 2023Switzerland: Jun. 2023Germany: Nov. 2022Italy: Nov. 2022 Management of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenanceCanada: Nov. 2023 QUVIVIQ (daridorexant) net sales in the first nine months of 2024 reached CHF 18 million in the EUCAN region. In the third quarter of 2024, net sales have increased by 46% compared to the second quarter of 2024. In Germany, QUVIVIQ was launched in November 2022. By law, sleep medications were then subject to a 4-week prescribing limitation (Anlage III BtMG). Following a review by the Federal Joint Committee (G-BA) this limitation was lifted for QUVIVIQ in November 2023. This makes it the only sleep medication in Germany that can be prescribed for long-term treatment of chronic insomnia. In December 2023, the price negotiated for QUVIVIQ under the AMNOG process became effective. Following the lifting of the prescribing limitation, the company submitted a second AMNOG dossier for the long-term treatment of chronic insomnia disorder (beyond 4 weeks), reflecting the indication approved by the EMA in 2022. The second AMNOG process is expected to end in March 2025. The progress made in Germany is reflected by the performance of QUVIVIQ on the market, with sales doubling in the first nine months of 2024 compared to the first nine months of 2023. In Italy, QUVIVIQ was launched in November 2022. Currently, QUVIVIQ can only be prescribed by neurologists, psychiatrists, and specialists from sleep centers, and no sleep therapy is reimbursed. The company submitted a reimbursement dossier in June 2023 and requested the expansion of the prescriber base. The submission – detailing the efficacy and safety profile of QUVIVIQ and its estimated budget impact and cost-effectiveness in Italy – is under review, with a hearing expected to take place before the end of the year. In Switzerland, QUVIVIQ was launched to the self-pay market in June 2023. Following the launch of QUVIVIQ, awareness and sales have increased solidly. Reimbursement discussions are ongoing and remain a priority for Switzerland. In Spain, QUVIVIQ was launched to the self-pay market in September 2023. Spain represents the largest insomnia market in Europe, as was apparent in the first months of this product’s availability, despite it only being launched to the self-pay market. The company submitted a reimbursement dossier to the Spanish authorities in July 2024, in order to allow equal access for all patients with chronic insomnia. In the UK, QUVIVIQ is recommended as first-line pharmaceutical treatment for patients with chronic insomnia, after, or as an alternative to, cognitive behavioral therapy for insomnia (CBT-I). QUVIVIQ was launched in October 2023 and the team has achieved full reimbursement throughout the UK. The priority in the UK is to secure regional access, which currently stands at around 80%, as well as raising awareness of QUVIVIQ among general practitioners. In Austria, QUVIVIQ was made available in February 2024. A reimbursement dossier was submitted in October 2024, with a conclusion expected in the second half of 2025. In France, QUVIVIQ was included in both the hospital and the retail formulary list of reimbursed pharmaceutical specialties in January 2024 and launched in March 2024 as the first and only pharmacotherapy recommended for the treatment of chronic insomnia disorder. There was a very strong uptake at launch largely due to the excellent market preparation work with psychiatrists. This can be seen by the fact that the majority of prescriptions are being made by the specialists, despite the French market being composed of 55’000 general practitioners who between them represent 75% of the insomnia prescriptions. As a result, the priority becomes expanding awareness to the primary care market to secure strong long-term growth. To address this, Idorsia is expanding its commercial reach from specialist prescribers to general practitioners (GPs) through a new commercial partnership with Menarini in France. In Sweden, QUVIVIQ was made available in September 2024. A reimbursement dossier was submitted in May 2024. As a result, a decision on reimbursement is expected by the end of 2024. In Canada, after being approved in April 2023, QUVIVIQ was launched in November 2023 to the private market, representing 55% of the Canadian insomnia market. The reimbursement dossier was submitted to private market payers in the third quarter of 2023 and currently stands at 80% coverage. The focus is now on public payers with the submission confirmation in Quebec received in October 2024 and submissions in all other provinces ongoing and to be completed by year end. Benjamin Limal, President of Europe and Canada region, commented:“Securing public access to Europe’s only dual orexin receptor antagonist remains our number one priority throughout the EUCAN region – this is the pathway to unlocking the true value of QUVIVIQ. Until then, the performance is satisfactory with a great adoption from specialists and a strong quarterly growth in demand and sales. As one of the newest launches, I have to mention France – QUVIVIQ is really off to a flying start and we are quickly reinforcing the launch momentum through a commercial partnership with Menarini, experts with established relationships in primary care, to handle the promotion of QUVIVIQ to GPs.” For more information about QUVIVIQ in the EU, see the Summary of Product Characteristics. For more information about QUVIVIQ in Switzerland, see the Patient Information and Information for Healthcare Professionals. For more information on the marketing authorization of QUVIVIQ in Canada, see the Product Monograph. ProductMechanism of actionIndicationCommercially available sinceDual endothelin receptor antagonistTreatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal productsApproved Jun. 2024 On June 27, 2024, the European Commission (EC) approved JERAYGO™ (aprocitentan) for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal products. The recommended dose is 12.5 mg orally once daily. The dose can be increased to 25 mg once daily for patients tolerating the 12.5 mg dose and in need of tighter blood pressure (BP) control. Further details on the approval, together with commentary from company management can be found in the dedicated press release available from the company corporate website. For more information about JERAYGO in the EU, see the Summary of Product Characteristics. Research & DevelopmentIdorsia has a diversified and balanced portfolio, comprising assets developed and/or marketed by Idorsia and assets that are partner-led to maximize the value we have created. Our drug discovery engine has produced innovative drugs with the potential to transform the treatment paradigm in multiple therapeutic areas, including CNS, cardiovascular, and immunological disorders, as well as orphan diseases. The company also has a vaccine platform for the discovery and development of glycoconjugate vaccines containing synthetic antigenic glycan molecules, with or without a carrier protein, to prevent infection. Idorsia-led portfolio CompoundMechanism of actionTarget indicationStatusQUVIVIQ™ (daridorexant)Dual orexin receptor antagonistInsomniaCommercially available in the US, Germany, Italy, Switzerland, Spain, the UK, Canada, Austria, France, and Sweden; approved throughout the EUTRYVIO™ (aprocitentan) Dual endothelin receptor antagonistSystemic hypertension in combination with other antihypertensivesCommercially available in the USJERAYGO™ (aprocitentan)Dual endothelin receptor antagonistResistant hypertension in combination with other antihypertensivesApproved in the EU; Marketing authorization applications submitted in the UK, Canada, and SwitzerlandLucerastatGlucosylceramide synthase inhibitorFabry diseasePhase 3 primary endpoint not met; open-label extension study ongoingPhase 3 focused on renal function in preparationDaridorexantDual orexin receptor antagonistPediatric insomniaPhase 2 in pediatric insomnia ongoingACT-1004-1239ACKR3/CXCR7 antagonistDemyelinating diseases including multiple sclerosis Phase 2 in preparationACT-777991CXCR3 antagonistVitiligoPhase 2 in preparationSinbaglustatGBA2/GCS inhibitorRare lysosomal storage disordersPhase 1 completeIDOR-1117-2520UndisclosedImmune-mediated disordersPhase 1 ongoingIDOR-1134-2831Synthetic glycan vaccineClostridium difficile infectionPhase 1 ongoing Further details including the current status of each project in our portfolio can be found in our innovation fact sheet. Idorsia partner-led portfolioFor Idorsia, sophisticated partnerships are a way of gaining strategic access to technologies or products and fully exploiting our discovery engine and clinical pipeline. We seek suitable external project partners to maximize the value of internal innovation. CompoundMechanism of actionTarget indicationPartner/statusQUVIVIQ™ (daridorexant)Dual orexin receptor antagonistInsomniaSimcere: Approved for the treatment of insomnia in Hong-KongQUVIVIQ™ (daridorexant)Dual orexin receptor antagonistInsomniaNxera Pharma: license to develop and commercialize for Asia-Pacific region (excluding China)Approved for the treatment of insomnia in JapanDaridorexantDual orexin receptor antagonistInsomniaSimcere: license to develop and commercialize for Greater China regionNDA submitted in Greater ChinaSelatogrelP2Y12 inhibitorAcute myocardial infarctionViatris: worldwide development and commercialization rightsPhase 3 “SOS-AMI” program ongoingCenerimodS1P1 receptor modulatorSystemic lupus erythematosusViatris: worldwide development and commercialization rights (excluding Japan, South Korea, and certain countries in the Asia-Pacific region)Phase 3 “OPUS” program ongoingDaridorexantDual orexin receptor antagonistPosttraumatic stress disorder (PTSD)US Department of Defense (DOD): Idorsia is supporting a clinical study sponsored by the US DOD to develop new therapies to treat PTSDACT-1002-4391EP2/EP4 receptor antagonistImmuno-oncologyOwkin: global license to develop and commercializePhase 1 in preparation On October 1, 2024, Nxera Pharma announced that it had entered a commercial partnership agreement with Shionogi & Co., Ltd regarding the distribution and sales for QUVIVIQ in Japan. At the same time, the previous commercialization agreement between Nxera and Mochida Pharmaceutical Co., Ltd. was terminated. After negotiation among Nxera, Shionogi and Mochida regarding the optimal sales scheme, Shionogi is solely responsible for distribution and sales activities in Japan. Idorsia and Neurocrine Biosciences had a collaboration for ACT-709478, Idorsia’s novel T-type calcium channel blocker. The compound was investigated as a treatment of pediatric patients with epileptic encephalopathy with continuous spike-and-wave during sleep (CSCW), a rare form of pediatric epilepsy. The Phase 2 study did not meet the primary endpoint in June 2022, and further analysis from an open-label extension study resulted in the decision to stop further development. As a result, the development agreement has come to an end. Further details including the current status of each project in our partner-led portfolio can be found in our innovation fact sheet. Results Day CenterInvestor community: To make your job easier, we provide all relevant documentation via the Results Day Center on our corporate website: www.idorsia.com/results-day-center. Upcoming Financial Updates Full Year 2024 Financial Reporting together with the publication of the Annual Report 2024 on February 27, 2025 Notes to the editor About IdorsiaIdorsia Ltd is reaching out for more – We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech-hub – Idorsia is specialized in the discovery, development, and commercialization of small molecules to transform the horizon of therapeutic options. Idorsia has a 25-year heritage of drug discovery, a broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, and commercial operations in Europe and North America – the ideal constellation for bringing innovative medicines to patients. Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 750 highly qualified specialists dedicated to realizing our ambitious targets. For further information, please contactAndrew C. WeissSenior Vice President, Head of Investor Relations & Corporate CommunicationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58 844 10 10investor.relations@idorsia.com media.relations@idorsia.com www.idorsia.com The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Attachment Press Release PDF

Drug ApprovalFinancial Statement

07 Oct 2024

·www.prnewswire.com

The Positive Topline Results From Phase III Study of UCB/Biogen's Dapirolizumab Pegol Brings a Ray of Hope in Systemic Lupus Erythematosus Therapeutic Space | DelveInsight

UCB and Biogen reported encouraging topline findings from the Phase III PHOENYCS GO trial, which assessed dapirolizumab pegol, a novel Fc-free anti-CD40L drug candidate, in individuals with moderate-to-severe SLE. The promising outcomes with dapirolizumab pegol signify significant advancements in creating treatments that can enhance the quality of life for individuals with lupus, a condition that continues to have considerable unmet medical needs, particularly impacting women. LAS VEGAS, Oct. 7, 2024 /PRNewswire/ -- Systemic lupus erythematosus is a long-lasting autoimmune disorder that can impact various areas of the body. Lupus arises when the immune system, typically responsible for defending against infections and illnesses, mistakenly targets the body's own tissues. This misguided response leads to inflammation and, in some instances, lasting damage to tissues, potentially affecting a wide range of organs including the skin, joints, heart, lungs, kidneys, blood cells, and brain. As per the estimates, the prevalence of systemic lupus erythematosus in the United States is approximately 500K cases in 2023. In females, prevalence rates are observed to be much greater than that of males, constituting more than 90% of the total prevalent cases in the US. In 2023, among the treated SLE patients, nearly 40% of patients became relapsed or refractory after the first line of therapy. The main goals of SLE treatment are to alleviate symptoms, prevent or reduce organ damage and disease flare-ups, minimize drug toxicity, and improve the patient's overall quality of life. The SLE treatment plan primarily includes antimalarial medications (like hydroxychloroquine), glucocorticoids (such as prednisone or similar), immunosuppressive drugs (including methotrexate, azathioprine, or mycophenolate), and biologics, in addition to nonsteroidal anti-inflammatory drugs (NSAIDs) for managing inflammation and pain. Biologics are specifically used for patients who do not respond to standard treatments or for those with severe, organ-threatening diseases. Currently, the biologics approved by the US FDA as adjunct therapies for SLE patients are BENLYSTA and SAPHNELO. In contrast, the use of rituximab for treating SLE is considered off-label. Learn more about the FDA-approved SLE drugs @ Drugs for Systemic Lupus Erythematosus Treatment BENLYSTA (belimumab) is a fully human monoclonal antibody that targets and inhibits BLyS (B-lymphocyte stimulator), a protein found at elevated levels in patients with systemic autoimmune diseases such as systemic lupus erythematosus and lupus nephritis. By binding to soluble BLyS, BENLYSTA prevents the prolonged survival of B cells, including autoreactive B cells, and reduces their differentiation into plasma cells that produce immunoglobulins. However, BENLYSTA does not directly bind to B cells. First approved by the US FDA in 2011, it is the only biologic therapy approved for the treatment of active SLE and LN in more than 50 years, including for pediatric patients. SAPHNELO (anifrolumab) is a fully human monoclonal antibody and the first of its kind, targeting subunit 1 of the type I interferon (IFN) receptor to inhibit type I IFN activity. Type I IFNs, including IFN-alpha, IFN-beta, and IFN-kappa, are cytokines that play a role in the inflammatory pathways associated with systemic lupus erythematosus. Most adults with SLE exhibit increased type I IFN signaling, which correlates with greater disease activity and severity. SAPHNELO has been approved for the treatment of SLE in over 60 countries, including the US, EU, and Japan, with ongoing reviews in additional regions. To know more about SLE treatment options, visit @ New Treatment for Systemic Lupus Erythematosus SLE pipeline possesses some drugs in mid and late-stage developments to be approved in the near future. The emerging landscape holds a diverse range of therapeutic alternatives for treatment, including Litifilimab (Biogen), Ianalumab (Novartis), Cenerimod (Idorsia/Viatris), Dapirolizumab pegol (UCB/Biogen), Telitacicept (RC18) (RemeGen), and others in different lines of treatment. The expected launch of these therapies shall further create a positive impact on the market. Discover which therapies are expected to grab major SLE market share @ Systemic Lupus Erythematosus Market Report Dapirolizumab pegol is a novel investigational treatment, consisting of a humanized, Fc-free antigen-binding (Fab') fragment conjugated with polyethylene glycol (PEG). It works by inhibiting CD40L signaling, which has been shown to reduce B cell activation, decrease autoantibody production, limit type 1 interferon (IFN) secretion, and suppress the activation of T cells and antigen-presenting cells (APCs). In September 2024, UCB and Biogen announced that the Phase III PHOENYCS GO trial achieved its primary goal, showing clinical improvements in patients with moderate-to-severe systemic lupus erythematosus. Additionally, key secondary endpoints, assessing disease activity and flare-ups, also demonstrated clinical improvements. Following the positive results from the PHOENYCS GO study, UCB and Biogen are launching a second Phase 3 trial of dapirolizumab pegol in 2024, named PHOENYCS FLY. Participants from the PHOENYCS GO study will continue to be monitored in a long-term open-label extension. Biogen is working on developing Litifilimab (BIIB059), an experimental humanized monoclonal antibody. This antibody specifically targets and binds to blood dendritic cell antigen 2 (BDCA2), a receptor found on plasmacytoid dendritic cells (pDCs). When BDCA2 is engaged, it inhibits the production of type I interferons (IFN-I) and other inflammatory molecules. BDCA2 is exclusively expressed on the surface of human pDCs. Litifilimab acts as an inhibitor of B-cell lymphocyte stimulator. Currently, Biogen is conducting Phase III clinical trials to evaluate its use for treating SLE. Ianalumab, developed by Novartis, is an antibody aimed at the B-cell activating factor receptor (BAFF-R). It is designed to inhibit BAFF-R signaling and deplete B cells through antibody-dependent cellular cytotoxicity. The drug is currently undergoing a Phase III clinical trial for systemic lupus erythematosus, with the company expecting to submit it for approval by 2027, according to a recent presentation. Cenerimod is an oral, once-daily tablet that acts as a highly selective modulator of the sphingosine-1-phosphate receptor 1 (S1P1). Although the exact cause of systemic lupus erythematosus is not fully understood, T and B lymphocytes are believed to be the primary immune cells involved in the disease's progression. These cells express the S1P1 receptor on their surface. In February 2024, Idorsia Pharmaceuticals formed a major global research and development partnership with Viatris to advance and commercialize two Phase III assets, selatogrel and cenerimod, on a global scale. Discover more about drugs for SLE in development @ Systemic Lupus Erythematosus Clinical Trials The anticipated launch of these emerging therapies for SLE are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the SLE market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for SLE is expected to grow from USD 3.2 billion in 2023 with a significant CAGR by 2034. This growth is mainly driven by ongoing clinical research and better diagnostic tools that might improve the prognosis of the disease. DelveInsight's latest published market report titled as Systemic Lupus Erythematosus Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the SLE country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The SLE market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total SLE Diagnosed Prevalent Cases Total SLE Diagnosed Prevalent Cases by Gender Total SLE Diagnosed Prevalent Cases by Age SLE Severity-Based Diagnosed Prevalent Cases Total SLE Treated Cases The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM SLE market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this SLE market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the SLE market. Also, stay abreast of the mitigating factors to improve your market position in the SLE therapeutic space. Related Reports Systemic Lupus Erythematosus Pipeline Systemic Lupus Erythematosus Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key myasthenia gravis companies, including Yake Biotechnology, UCB, Sorrento Therapeutics, SinoMab Bioscience Ltd, Shanghai Junshi Biosciences, Sareum, Sanofi, Roche, Rheos Medicine, Resolve, Provention Bio, Pfizer, Novartis, Neovacs, Merck, Medsenic, Landos Biopharma, Kezar Life Sciences, Kangpu Biopharmaceuticals, Janssen Research & Development, Janssen, InnoCare, ImmuPharma, I-MAB Biopharma, ILTOO, Idorsia Pharmaceuticals, Horizon Therapeutics, Genovax, Exinda Thearapeutics, Equillium, Eli Lilly and Company, Eisai, Daiichi Sankyo Company, Corestem, Corbus Pharmaceuticals, Citryll BV, Chipscreen Biosciences, Carna Bioscience, Bristol-Myers Squibb, Brickell Biotech, Boston Pharmaceuticals, Biogen, Athos Therapeutics, Asahi Kasei Pharma, Aria Pharmaceuticals, Antengene Therapeutics, Amgen, Alpine Immune Sciences, Akeso Biopharma, AbbVie, among others. Systemic Lupus Erythematosus Epidemiology Systemic Lupus Erythematosus Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted SLE epidemiology in the 7MM. Lupus Nephritis Market Lupus Nephritis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key lupus nephritis companies, including NOVARTIS, MORPHOSYS, ASTRAZENECA, ROCHE, KEZAR LIFE SCIENCES, ALEXION PHARMACEUTICALS, NOVARTIS, CABALETTA BIO, among others. Lupus Nephritis Pipeline Lupus Nephritis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key lupus nephritis companies, including Inflection Biosciences, Equillium, Roche, Horizon Therapeutics, BeiGene, Janssen Research & Development, ImmPACT Bio, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug Approval

17 Sep 2024

·www.fiercepharma.com

Lupus landscape 'poised for evolution' as US doctors eagerly await new entrants

Biogen's litifilimab "stands out as an especially strong competitor" to Benlysta and Saphnelo, according to Spherix Global Insights analysts. New biologics such as GSK's Benlysta and AstraZeneca's Saphnelo, along with off-label drugs, have been the mainstay for systemic lupus erythematosus (SLE) treatment for many years. However, the landscape may be about to change with the introduction of new medicines and indications from other approved treatments.That's according to Spherix Global Insights analysts who spoke to 101 U.S. rheumatologists about current and future treatments for SLE, a landscape they see as “poised for evolution.”There are several types of lupus, with SLE the most common. The condition is caused by an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage. Organ damage can occur in up to 48% of people living with lupus, most within five years of diagnosis, with lupus flares also upping the risk of organ damage.GSK’s SLE drug Benlysta, which was approved by the FDA in 2011, has now become a blockbuster medicine, while AstraZeneca’s new challenger Saphnelo, FDA-approved in 2021, remains some way behind the market leader in Benlysta in terms of sales.Doctors have also relied on off-label use of other older medicines, including rituximab. However, Spherix found in a 2023 report, this use has begun to lose favor among rheumatologists as they turn to newer biologics.Now, Spherix has found that an experimental drug from Biogen, litifilimab, “stands out as an especially strong competitor” to Benlysta and Saphnelo, according to its report. Talking to rheumatologists, Spherix analysts said that they believe litifilimab’s latest midstage data, notably its 26% improvement in SRI-4 response (a measurement on how well a patient responds to treatment) over placebo, “demonstrates a superior treatment profile compared to existing biologics and other promising therapies.”There is also hope from new indications from already-approved drugs in the form of AbbVie’s blockbuster immunology drug Rinvoq, which is in phase 3 testing for SLE, and Bristol Myers Squibb’s Sotyktu, which presented positive data in SLE at the start of the year.Spherix found that these oral therapies “offer convenience for patients and may appeal to rheumatologists seeking alternative treatment options.”Getting patients to stay on them, however, can be a “challenge,” while black box warnings on JAKs (i.e., Rinvoq) “may prevent use in earlier lines of SLE treatment,” according to Spherix. Despite that, rheumatologists “are most eager to see Rinvoq approved for SLE, followed by Sotyktu and litifilimab, all of which are believed to be potentially effective for skin manifestations,” the report found.There are also other investigational contenders in the form of UCB Pharma’s dapirolizumab pegol and Idorsia’s cenerimod.All new entrants must, however, be mindful of the “dominance” of Benlysta, the analysts conclude, which “remains a preferred choice” in both SLE and lupus nephritis.

Clinical ResultDrug ApprovalPhase 3

100 Deals associated with Cenerimod

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D11283	-	-	DB12705

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Systemic Lupus Erythematosus	Phase 3	PH	Idorsia Pharmaceuticals Ltd.	13 Dec 2022
Systemic Lupus Erythematosus	Phase 3	BG	Idorsia Pharmaceuticals Ltd.	13 Dec 2022
Systemic Lupus Erythematosus	Phase 3	TW	Idorsia Pharmaceuticals Ltd.	13 Dec 2022
Systemic Lupus Erythematosus	Phase 3	KR	Idorsia Pharmaceuticals Ltd.	13 Dec 2022
Systemic Lupus Erythematosus	Phase 3	GR	Idorsia Pharmaceuticals Ltd.	13 Dec 2022
Systemic Lupus Erythematosus	Phase 3	MX	Idorsia Pharmaceuticals Ltd.	13 Dec 2022
Systemic Lupus Erythematosus	Phase 3	FR	Idorsia Pharmaceuticals Ltd.	13 Dec 2022
Systemic Lupus Erythematosus	Phase 3	UA	Idorsia Pharmaceuticals Ltd.	13 Dec 2022
Systemic Lupus Erythematosus	Phase 3	US	Idorsia Pharmaceuticals Ltd.	13 Dec 2022
Systemic Lupus Erythematosus	Phase 3	AR	Idorsia Pharmaceuticals Ltd.	13 Dec 2022

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03742037 (CARE, EULAR2023)	Phase 2	IFN-1 gene expression signature \| anti-dsDNA antibody levels	427	Cenerimod 4 mg	stdmglladq(cqlfkuhvcz) = fnrfvddhte qdmzybhbmc (uxvmncsxea ) View more	Positive	31 May 2023
				Placebo	stdmglladq(cqlfkuhvcz) = npskuvlray qdmzybhbmc (uxvmncsxea ) View more
NCT02472795 (CTgov)	Phase 1/2	Systemic Lupus Erythematosus	105	Cenerimod (Cenerimod 0.5 mg (Part A))	bysalybljj(xuneatizwh) = opdcgeailt xuzimtdrzb (skwbdsucjg, pckxddbfsu - ydwzmrzcff) View more	-	26 Feb 2020
				Cenerimod (Cenerimod 1 mg (Part A))	bysalybljj(xuneatizwh) = gxgyubwcna xuzimtdrzb (skwbdsucjg, lretsdiaki - jlyngbccqu) View more
NCT02472795 (Pubmed \| Lupus Sci Med)	Phase 1/2	Systemic Lupus Erythematosus	105	Cenerimod 0.5 mg	(loapmgyuab) = kkmjwiviol mczhrataic (kjnwibglfg )	Positive	01 Jan 2019
				Cenerimod 1 mg	(loapmgyuab) = epoeeomtom mczhrataic (kjnwibglfg )

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