A Phase 2B, Multicenter, 30-week, Prospective, Cross-over, Double-blind, Randomized, Placebo-controlled Study Followed by a 52-Week Open-label Extension Study to Evaluate the Efficacy and Safety of Basimglurant Adjunctive to Ongoing Anticonvulsive Therapy in Children, Adolescents, and Young Adults with Seizures Associated with Tuberous Sclerosis Complex

Start Date04 May 2023

Sponsor / Collaborator

Noema Pharma AGStartup

[+1]

NCT05059327

/ Active, not recruitingPhase 2

A Phase 2B, Multicenter, 30-week, Prospective, Cross-over, Double-blind, Randomized, Placebo-controlled Study Followed by a 52-Week Open-label Extension Study to Evaluate the Efficacy and Safety of Basimglurant Adjunctive to Ongoing Anticonvulsive Therapy in Children, Adolescents, and Young Adults with Uncontrolled Seizures Associated with Tuberous Sclerosis Complex

The study intends to show that basimglurant (NOE-101) provides effective seizure control in children, adolescents and young adults with Tuberous Sclerosis Complex (TSC).

Start Date03 Mar 2022

Sponsor / Collaborator

Noema Pharma AGStartup

NCT05217628

/ RecruitingPhase 2/3

A Phase II/III, Multicentre, 8-week Run-in Phase Followed by a 12-week, Prospective, Parallel-group, Double-blind, Randomized Withdrawal, Placebo-controlled Study, with a 52 Week Open Label Extension, to Evaluate the Efficacy and Safety of Daily 1.5 to 3.5 Mg Basimglurant in Patients with Pain Associated with Trigeminal Neuralgia with Suboptimal Response to Their Current Anti-pain Therapy.

Trigeminal neuralgia (TN), also called "tic douloureux", is the most common form of craniofacial neuropathic pain and is considered the cause of one of the most painful afflictions known in medical practice.
This study is designed to evaluate the efficacy and safety of 1.5mg - 3.5mg basimglurant in adults with TN.

Start Date11 Jan 2022

Sponsor / Collaborator

Noema Pharma AGStartup

100 Clinical Results associated with Basimglurant Sulfate

100 Translational Medicine associated with Basimglurant Sulfate

100 Patents (Medical) associated with Basimglurant Sulfate

Literatures (Medical) associated with Basimglurant Sulfate

01 Sep 2022·Pharmacology Biochemistry and Behavior

Clinical investigations of compounds targeting metabotropic glutamate receptors

Review

Author: Smith, Jodi L ; Witkin, Jeffrey M ; Pandey, Kamal P

Pharmacological modulation of glutamate has long been considered to be of immense therapeutic utility. The metabotropic glutamate receptors (mGluRs) are potential targets for safely altering glutamate-driven excitation. Data support the potential therapeutic use of mGluR modulators in the treatment of anxiety, depression, schizophrenia, and other psychiatric disorders, pain, epilepsy, as well as neurodegenerative and neurodevelopmental disorders. For each of the three mGluR groups, compounds have been constructed that produce either potentiation or functional blockade. PET ligands for mGlu5Rs have been studied in a range of patient populations and several mGlu5R antagonists have been tested for potential efficacy in patients including mavoglurant, diploglurant, basimglurant, GET 73, and ADX10059. Efficacy with mGlu5R antagonists has been reported in trials with patients with gastroesophageal reflux disease; data from patients with Parkinson's disease or Fragile X syndrome have not been as robust as hoped. Fenobam was approved for use as an anxiolytic prior to its recognition as an mGlu5R antagonist. mGlu2/3R agonists (pomaglumated methionil) and mGlu2R agonists (JNJ-40411813, AZD 8529, and LY2979165) have been studied in patients with schizophrenia with promising but mixed results. Antagonists of mGlu2/3Rs (decoglurant and TS-161) have been studied in depression where TS-161 has advanced into a planned Phase 2 study in treatment-resistant depression. The Group III mGluRs are the least developed of the mGluR receptor targets. The mGlu4R potentiator, foliglurax, did not meet its primary endpoint in patients with Parkinson's disease. Ongoing efforts to develop mGluR-targeted compounds continue to promise these glutamate modulators as medicines for psychiatric and neurological disorders.

01 May 2021·CNS DrugsQ2 · MEDICINE

Novel Glutamatergic Modulators for the Treatment of Mood Disorders: Current Status

Q2 · MEDICINE

Review

Author: Henter, Ioline D ; Park, Lawrence T ; Zarate, Carlos A

The efficacy of standard antidepressants is limited for many patients with mood disorders such as major depressive disorder (MDD) and bipolar depression, underscoring the urgent need to develop novel therapeutics. Both clinical and preclinical studies have implicated glutamatergic system dysfunction in the pathophysiology of mood disorders. In particular, rapid reductions in depressive symptoms have been observed in response to subanesthetic doses of the glutamatergic modulator racemic (R,S)-ketamine in individuals with mood disorders. These results have prompted investigation into other glutamatergic modulators for depression, both as monotherapy and adjunctively. Several glutamate receptor-modulating agents have been tested in proof-of-concept studies for mood disorders. This manuscript gives a brief overview of the glutamate system and its relevance to rapid antidepressant response and discusses the existing clinical evidence for glutamate receptor-modulating agents, including (1) broad glutamatergic modulators ((R,S)-ketamine, esketamine, (R)-ketamine, (2R,6R)-hydroxynorketamine [HNK], dextromethorphan, Nuedexta [a combination of dextromethorphan and quinidine], deudextromethorphan [AVP-786], axsome [AXS-05], dextromethadone [REL-1017], nitrous oxide, AZD6765, CLE100, AGN-241751); (2) glycine site modulators (D-cycloserine [DCS], NRX-101, rapastinel [GLYX-13], apimostinel [NRX-1074], sarcosine, 4-chlorokynurenine [4-Cl-KYN/AV-101]); (3) subunit (NR2B)-specific N-methyl-D-aspartate (NMDA) receptor antagonists (eliprodil [EVT-101], traxoprodil [CP-101,606], rislenemdaz [MK-0657/CERC-301]); (4) metabotropic glutamate receptor (mGluR) modulators (basimglurant, AZD2066, RG1578, TS-161); and (5) mammalian target of rapamycin complex 1 (mTORC1) activators (NV-5138). Many of these agents are still in the preliminary stages of development. Furthermore, to date, most have demonstrated relatively modest effects compared with (R,S)-ketamine and esketamine, though some have shown more favorable characteristics. Of these novel agents, the most promising, and the ones for which the most evidence exists, appear to be those targeting ionotropic glutamate receptors.

01 Apr 2021·The Journal of Pharmacology and Experimental TherapeuticsQ3 · MEDICINE

Understanding Exposure-Receptor Occupancy Relationships for Metabotropic Glutamate Receptor 5 Negative Allosteric Modulators across a Range of Preclinical and Clinical Studies

Q3 · MEDICINE

Article

Author: Bennett, Kirstie A ; MacSweeney, Cliona P ; Sergeev, Eugenia ; Cooper, Anne E ; Bakker, Geor

The metabotropic glutamate receptor 5 (mGlu₅) is a recognized central nervous system therapeutic target for which several negative allosteric modulator (NAM) drug candidates have or are continuing to be investigated for various disease indications in clinical development. Direct measurement of target receptor occupancy (RO) is extremely useful to help design and interpret efficacy and safety in nonclinical and clinical studies. In the mGlu₅ field, this has been successfully achieved by monitoring displacement of radiolabeled ligands, specifically binding to the mGlu₅ receptor, in the presence of an mGlu₅ NAM using in vivo and ex vivo binding in rodents and positron emission tomography imaging in cynomolgus monkeys and humans. The aim of this study was to measure the RO of the mGlu₅ NAM HTL0014242 in rodents and cynomolgus monkeys and to compare its plasma and brain exposure-RO relationships with those of clinically tested mGlu₅ NAMs dipraglurant, mavoglurant, and basimglurant. Potential sources of variability that may contribute to these relationships were explored. Distinct plasma exposure-response relationships were found for each mGlu₅ NAM, with >100-fold difference in plasma exposure for a given level of RO. However, a unified exposure-response relationship was observed when both unbound brain concentration and mGlu₅ affinity were considered. This relationship showed <10-fold overall difference, was fitted with a Hill slope that was not significantly different from 1, and appeared consistent with a simple E_max model. This is the first time this type of comparison has been conducted, demonstrating a unified brain exposure-RO relationship across several species and mGlu₅ NAMs with diverse properties. SIGNIFICANCE STATEMENT: Despite the long history of mGlu₅ as a therapeutic target and progression of multiple compounds to the clinic, no formal comparison of exposure-receptor occupancy relationships has been conducted. The data from this study indicate for the first time that a consistent, unified relationship can be observed between exposure and mGlu₅ receptor occupancy when unbound brain concentration and receptor affinity are taken into account across a range of species for a diverse set of mGlu₅ negative allosteric modulators, including a new drug candidate, HTL0014242.

News (Medical) associated with Basimglurant Sulfate

11 Dec 2024

·endpts.com

BenevolentAI restructures; Cimeio, Kyowa ink cell therapy deal

Plus, news about NewAmsterdam, Rocket, ImmunityBio, CG Oncology, Spruce Biosciences, Pharming, Veradermics, Noema Pharma, Ambrosia Biosciences, EsoBiotec, Cellectar Biosciences and Hepion: BenevolentAI’s overhaul: The struggling AI biotech said it plans to lay off staff, consider delisting from the Euronext Amsterdam stock exchange, partner its early-stage assets and undergo other additional organizational shifts as co-founder Ken Mulvany returns . Its Amsterdam-listed stock was down 10% on Wednesday. — Kyle LaHucik Cimeio Therapeutics, Kyowa Kirin make a deal: The Japanese drugmaker is paying up to $300 million as part of an agreement to develop new cell therapies. Additional financial terms were not disclosed. — Jaimy Lee At least three public offerings have been disclosed over the past day, including NewAmsterdam ’s bid to raise $300 million; Rocket ’s upsized $165 million offering ; ImmunityBio ’s $100 million financing ; and CG Oncology ’s offering , which has yet to be priced. — Jaimy Lee Spruce’s Phase 2b fail for endocrine disorder drug: The South San Francisco biotech said tildacerfont administered once daily did not meet the primary endpoint of glucocorticoid reduction in a mid-stage study of people with adult congenital adrenal hyperplasia. But the trial’s principal investigator said the data suggest twice daily dosing may be more effective. Its stock $SPRB was down about 25% on Wednesday morning. — Ayisha Sharma Pharming’s rare disease med passes Phase 3 test in kids: The Dutch drugmaker’s Joenja for activated phosphoinositide 3-kinase delta syndrome (APDS) met the primary endpoints in a late-stage trial of patients aged four to 11 years old. Joenja won FDA approval for APDS patients aged 12 and older in March 2023. Pharming plans to submit global regulatory filings in children starting in 2025. — Ayisha Sharma Veradermics’ $75M Series B: The Connecticut-based dermatology and aesthetics biotech raised the financing as it begins a Phase 2/3 study in hair loss. — Kyle LaHucik Noema adds $35M from EQT Life Sciences: A second close of a Series B first announced in March of last year brings the total for the round to CHF 130 million, which is about $147 million. The cash will fund Noema’s four ongoing Phase 2 trials: mGluR5 negative allosteric modulator basimglurant in trigeminal neuralgia and seizures in tuberous sclerosis complex; gemlapodect, a PDE10a inhibitor, in Tourette syndrome; and NOE-115, a monoamine modulator, in menopause symptoms. — Elizabeth Cairns Merck backs Ambrosia: The New Jersey pharma giant invested in the biotech’s Series A, which now totals $25 million. Ambrosia previously announced plans to take over a former Pfizer site in Boulder as it builds out an oral small-molecule pipeline for obesity and metabolic disorders. — Kyle LaHucik EsoBiotec scores €22M: The Belgian cell therapy specialist raised the equivalent of $23 million from backers that include Thuja Capital, UCB Ventures and Invivo Partners. The company’s immune-shielded lentiviral vector, which is called ESO-T01, is designed to reprogram T lymphocytes into BCMA CAR-T cells in vivo . It will enter an investigator-initiated trial in multiple myeloma in China, its first in humans, and data are expected in the second half of 2025, which could allow expansion to indications including autoimmune diseases. — Elizabeth Cairns Cellectar lays off 60% of its workers: The biotech is prioritizing its pipeline and letting go of staff. Cellectar had 20 employees at the end of 2023. Its stock price $CLRB sank 62% in pre-market trading on Wednesday. — Kyle LaHucik Hepion Pharmaceuticals ends merger plans with Pharma Two B. — Jaimy Lee

Cell TherapyPhase 3Phase 2Drug ApprovalClinical Result

11 Dec 2024

·www.prnewswire.com

EQT Life Sciences Leads Series B Extension in Noema Pharma, Raising Total Series B Financing to CHF 130 million

Proceeds will be used to enable key late-stage clinical trial readouts for assets across several underserved neurological diseases with high unmet medical need. EQT Life Sciences has led the extension, and joins a consortium of prominent global biotechnology investors. The investment builds on EQT Life Sciences' previous successful partnership with neurology-focused repeat entrepreneur and Noema Pharma CEO Ilise Lombardo, MD STOCKHOLM, Dec. 11, 2024 /PRNewswire/ -- EQT Life Sciences is pleased to announce that the LSP 7 fund has invested in Noema Pharma ("the Company"). The clinical-stage biotech company headquartered in Basel, Switzerland is developing a pipeline of first-in-disease therapeutics that address central nervous system (CNS) disorders. The Series B extension brings the total capital raised in the round to CHF 130 million, including prior investments from Forbion, Jeito Capital, Sofinnova Partners, Gilde Healthcare, Polaris Partners, Invus and UPMC Enterprises. CNS disorders are a significant area of unmet medical need, affecting hundreds of millions of people worldwide who often face inadequate treatment options with limited effectiveness and significant side effects. Many of the conditions targeted by Noema Pharma have historically been difficult to treat due to their complex nature and the lack of effective therapies. By leveraging its diverse portfolio of neurological assets and innovative clinical pipeline, Noema Pharma is strongly positioned to address these debilitating disorders and provide much-needed hope and transformative solutions to patients living with these life-altering challenges. The Company's portfolio includes four active Phase 2 trials, with key readouts from all studies anticipated in 2025. Proceeds from the financing will drive the continued development of Noema Pharma's clinical-stage assets, including its lead candidate basimglurant (NOE-101), a mGluR5 inhibitor currently in Phase 2 trials for severe pain in trigeminal neuralgia (TN) and seizures in tuberous sclerosis complex (TSC). Additionally, the Company is advancing gemlapodect (NOE-105), a PDE10a inhibitor in Phase 2 for Tourette syndrome and childhood onset fluency disorder (COFD or stuttering), as well as NOE-115, a broad-spectrum monoamine modulator in a Phase 2 trial for vasomotor symptoms and additional symptoms of menopause. Ilise Lombardo, MD, CEO of Noema Pharma, stated: "We are thrilled to welcome EQT Life Sciences as a lead investor and to have Felice join our Board. Their support and expertise will be invaluable as we progress our clinical programs and strive to make a meaningful impact on patients' lives." Felice Verduyn-van Weegen, Partner at EQT who is joining the Company's Board of Directors, commented: "Noema Pharma's innovative approach to CNS disorders aligns very well with our investment strategy and we are excited to support their late-stage clinical pipeline and transformative therapies. Having worked with Ilise Lombardo on a previous successful investment, her exceptional leadership as a repeat entrepreneur further reinforces our confidence in Noema's potential to deliver meaningful impact to patients in need." Contact EQT Press Office, [email protected] This information was brought to you by Cision The following files are available for download: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2

11 Dec 2024

·www.businesswire.com

Noema Pharma extends Series B financing round, closing at CHF 130 Million ($147 Million)

BASEL, Switzerland--( BUSINESS WIRE )-- Noema Pharma , a clinical-stage biotech company targeting debilitating central nervous system (CNS) disorders, announced the successful close of a Series B extension financing round with an investment from EQT Life Sciences, bringing the total capital raised in the round to CHF 130 million (approx. USD 147 million). With its investment in Noema Pharma, EQT Life Sciences joins the syndicate of previous Series B investors including Forbion, Jeito Capital, Sofinnova Partners, Gilde Healthcare, Polaris Partners, Invus and UPMC Enterprises. The new financing will support Noema Pharma’s four active Phase 2 trials, with key data readouts anticipated in 2025. This includes additional development activities for basimglurant (NOE-101), an mGluR5 negative allosteric modulator currently in Phase 2 trials for severe pain in trigeminal neuralgia (TN) and seizures in tuberous sclerosis complex (TSC); gemlapodect (NOE-105), a PDE10a inhibitor in a Phase 2b trial for Tourette syndrome and under development for childhood-onset fluency disorder (COFD or stuttering); and NOE-115, a broad-spectrum monoamine modulator in a Phase 2 trial for vasomotor symptoms and other symptoms of menopause. Ilise Lombardo, MD, CEO of Noema Pharma, stated: " This latest financing underscores the strong support and confidence from investors in Noema’s vision to treat neuroscience-based conditions. We are thrilled to welcome EQT Life Sciences into this strong syndicate of investors and have Felice join our Board. EQT’s support and expertise alongside our syndicate of investors will be invaluable as we progress our clinical programs and strive to make a meaningful impact on patients' lives." Felice Verduyn-van Weegen , Partner at EQT and member of the Board at Noema, commented: " Noema Pharma's innovative approach to CNS disorders aligns very well with our investment strategy and we are excited to support their late-stage clinical pipeline and transformative therapies. Having worked with Ilise Lombardo on a previous successful investment, her exceptional leadership as a repeat entrepreneur reinforces our confidence in Noema's potential to deliver meaningful impact to patients in need.” The Series B extension follows the initial Series B financing of CHF 103 million (USD 112 million) announced on March 2023, and a CHF 54 million (approx. USD 60 million) Series A round in December 2020. Noema Pharma was founded in 2019 with seed investment from Sofinnova Partners. Notes to Editors About Noema Pharma Noema Pharma is a clinical-stage biotech company advancing a portfolio of transformative, first-in-disease therapeutics targeting neuroscience-based conditions with high unmet need. Noema has four programs currently in active Phase 2 clinical trials evaluating seizures in Tuberous Sclerosis Complex, pain in Trigeminal Neuralgia, Tourette syndrome and vasomotor symptoms plus CNS-mediated symptoms of menopause with readouts expected in 2025. Noema was founded by leading venture capital firm Sofinnova Partners and is supported by current investors including Forbion, Gilde Healthcare, Invus, Jeito Capital, Polaris Partners and UPMC Enterprises. Learn more at www.noemapharma.com . About EQT Life Sciences EQT Life Sciences was formed in 2022 following the integration of LSP, a leading European life sciences venture capital firm, into the EQT platform. As LSP, the firm raised over EUR 3.0 billion and supported the growth of more than 150 companies since it started to invest over 30 years ago. With a dedicated team of highly experienced investment professionals coming from backgrounds in medicine, science, business, and finance, EQT Life Sciences backs entrepreneurs who have ideas that could truly make a difference for patients. The team combines deep sector knowledge, analytical skills, and investment experience to provide the added value that entrepreneurs seek. For more information, go to eqtgroup.com/private-capital/life-sciences/

Phase 2

100 Deals associated with Basimglurant Sulfate

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KEGG	Wiki	ATC	Drug Bank
-	Basimglurant Sulfate	-	DB11833

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Pain	Phase 3	GB	Noema Pharma AGStartup	11 Jan 2022
Pain	Phase 3	PL	Noema Pharma AGStartup	11 Jan 2022
Pain	Phase 3	TR	Noema Pharma AGStartup	11 Jan 2022
Pain	Phase 3	US	Noema Pharma AGStartup	11 Jan 2022
Pain	Phase 3	IT	Noema Pharma AGStartup	11 Jan 2022
Pain	Phase 3	DE	Noema Pharma AGStartup	11 Jan 2022
Pain	Phase 3	DK	Noema Pharma AGStartup	11 Jan 2022
Pain	Phase 3	ES	Noema Pharma AGStartup	11 Jan 2022
Trigeminal Neuralgia	Phase 3	US	Noema Pharma AGStartup	11 Jan 2022
Trigeminal Neuralgia	Phase 3	ES	Noema Pharma AGStartup	11 Jan 2022

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