Keloids are common, benign cutaneous overgrowths that manifest clinically as raised, hypertrophic, often hyperpigmented lesions which are formed in response to dermal injury or idiopathic stimuli. Although keloids are a common disease, it's exact incidence and prevalence is not known. Despite the debilitating nature of keloids, current treatment modalities are limited in efficacy; there is no universally effective therapy available to patients. The research team hypothesize that ritlecitinib as a JAK3/TEC inhibitor will be able to reverse both the systemic and local keloid disease process by re-establishing immune homeostasis.

Start Date13 Aug 2024

Sponsor / Collaborator

Icahn School of Medicine at Mount Sinai

[+1]

NCT06531109 / RecruitingNot Applicable

PRESTO - Characterization and Clinical Outcomes of Alopecia Areata (AA) Patients Treated With Ritlecitinib in a Real-world (RW) Cohort: A Multinational, Prospective Observational Study.

Alopecia areata (AA) is a chronic relapsing autoimmune disease characterized by nonscarring hair loss affecting children, adolescents, and adults across all ages, races, and genders. AA primarily affects the scalp; however, it also can affect nails, eyelashes, eyebrows, and other hair follicles on the patient's body. The 3 main types of AA are:
* Patchy alopecia (PA), as seen in 90% of clinical diagnoses
* Alopecia totalis (AT), that affects all scalp hair
* Alopecia universalis (AU), involving all scalp, face, and body hair Dermatologist preferences for utility and order of skin-directed therapies to treat AA vary widely, with treatment choices based on various factors such as patients' age, disease duration and severity (Meah et al., 2020).
Ritlecitinib is a bioavailable small molecule that irreversibly binds to Janus kinase-3 (JAK3) and Tyrosine kinase Expressed in the hepatocellular Carcinoma kinase family (TEC). Ritlecitinib 50 mg once daily was approved by the FDA 23 June 2023 and EMA 20 July 2023 for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older. In Japan, ritlecitinib was approved on 26 June 2023 for the treatment of alopecia areata (limited to intractable cases involving widespread hair loss). Additional countries have since approved ritlecitinib. Those approvals are based on the results of the ritlecitinib pivotal phase 2b/3 study (ALLEGRO 2b/3) which examined efficacy and safety of ritlecitinib in AA patients globally.
Despite positive results from the ALLEGRO program, there is still lack of evidence on ritlecitinib patients' characteristics and clinical outcomes in routine clinical practice. The investigators will evaluate patient and disease characteristics, treatment patterns, and clinical and patient-reported outcomes among patients with AA who are receiving ritlecitinib.
The aim of this study is to measure effectiveness of ritlecitinib in a real-world setting. Ritlecitinib will be prescribed to patients according to the approved product label. Treatment will be guided by clinical judgement of the treating physician ie, study investigators, according to standard of care, independently of this study.

Start Date07 Aug 2024

Sponsor / Collaborator

Pfizer Inc.

NCT06573593 / RecruitingNot ApplicableIIT

Efficacy and Safety of JAK Inhibitors in Patients With Alopecia Areata: a Single-center, Real-world Study

The introduction of Janus Kinase inhibitors (JAKi) seems to revolutionize the field of alopecia areata (AA) therapeutics. However, the ideal JAKi is not yet settled and the real-world data are still missing. To provide evidence about effectiveness and safety of different JAKi including tofacitinib, baricitinib, ritlecitinib，abrocitinib, upadacitinib and ifidancitinib in real-world settings and describe baseline disease characteristics and patients profiles that are considered good candidates for JAKi in the daily practice. Furthermore, we intended to investigate the efficacy and safety of JAK Inhibitors in patients With AA, as well as to provide clinical evidence for the clinicians and patients when they formulate individualized treatment plans.

Start Date29 Jul 2024

Sponsor / Collaborator

Second Affiliated Hospital Zhejiang University College of

100 Clinical Results associated with Ritlecitinib Tosilate

100 Translational Medicine associated with Ritlecitinib Tosilate

100 Patents (Medical) associated with Ritlecitinib Tosilate

Literatures (Medical) associated with Ritlecitinib Tosilate

01 Dec 2024·JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

Response to ritlecitinib with or without narrow-band UVB add-on therapy in patients with active nonsegmental vitiligo: results from a phase 2b extension study

Article

Author: Adiri, Roni ; Shore, Ronald N ; Napatalung, Lynne ; Peeva, Elena ; Guttman-Yassky, Emma ; Pandya, Amit G ; Ezzedine, Khaled ; Hamzavi, Iltefat ; Ghosh, Pranab ; Yamaguchi, Yuji

BACKGROUND:

Ritlecitinib demonstrated efficacy in a phase 2b trial of nonsegmental vitiligo.

OBJECTIVE:

To evaluate the efficacy and tolerability of ritlecitinib with add-on narrow-band UVB (nbUVB) phototherapy in patients with nonsegmental vitiligo.

METHODS:

Following a 24-week, placebo-controlled, dose-ranging period, patients received ritlecitinib 200mg for 4 weeks then 50mg for 20 weeks, with or without nbUVB phototherapy 2x/week. Missing data were handled using last observation carried forward (LOCF) and observed case (OC).

RESULTS:

Forty-three patients received ritlecitinib+nbUVB and 187 received ritlecitinib-monotherapy. Nine patients receiving ritlecitinib+nbUVB discontinued due to nbUVB group-specific efficacy criteria requiring >10% improvement in %change from baseline (%CFB) in Total-Vitiligo Area Scoring Index (T-VASI) at week 12. At week 24, mean %CFB in Facial-VASI score was -57.0 vs -51.5 (LOCF; P=0.158) and -69.6 vs -55.1 (OC; P=0.009), for ritlecitinib+nbUVB vs ritlecitinib-monotherapy, respectively. Mean %CFB in T-VASI at week 24 was -29.4 vs -21.2 (LOCF; P=0.043) and -46.8 vs -24.5 (OC; P<0.001), respectively. nbUVB addition to ritlecitinib was well-tolerated with no new safety signals.

LIMITATIONS:

Exploratory analysis; discontinuation criterion applied only to the ritlecitinib+nbUVB group; small sample size.

CONCLUSION:

Ritlecitinib alone and with nbUVB therapy improved facial and total body repigmentation and was well-tolerated. Adding nbUVB may improve ritlecitinib efficacy.

01 Dec 2024·Expert Opinion on Drug Metabolism & Toxicology

Unraveling Ritlecitinib: an in-depth analysis of JAK3 inhibitor for the treatment of alopecia areata

Review

Author: Ondieki, Dariel ; Rodriguez, Katherine A. ; Kar, Supratik ; Nunez, Mariela

INTRODUCTION:

Alopecia Areata (AA), characterized by non-scarring hair loss due to the dysregulation of the JAK/STAT pathway, has long lacked effective treatment. In 2023, Ritlecitinib, a novel Janus kinase (JAK) 3 and tyrosine kinase family inhibitor, received its first approval from the US FDA to treat AA, followed by approvals in Japan, Europe, China, and the UK. This development aims to address the challenges faced by millions of individuals affected by this condition globally.

AREAS COVERED:

This review offers an overview of Ritlecitinib's pharmacological properties, biological targets, and development strategies. It examines its mechanism of action, pharmacokinetics, pharmacodynamics, and clinical trial insights. Additionally, it covers the drug's chemical synthesis, contraindications, drug interactions, and potential adverse effects, with special attention to its use in adolescents, pregnant women, and the elderly.

EXPERT OPINION:

Ritlecitinib represents a significant advancement in treating AA, offering a targeted approach with promising efficacy and a favorable safety profile. While long-term safety data and real-world effectiveness studies are needed, its oral administration and efficacy in both adults and adolescents position it as a potentially transformative therapy. Ongoing research should focus on optimizing treatment strategies, identifying predictive biomarkers, and assessing cost-effectiveness to fully realize Ritlecitinib's potential in improving outcomes.

01 Nov 2024·JOURNAL OF DERMATOLOGY

Efficacy and safety of ritlecitinib, an oral JAK3/TEC family kinase inhibitor, in adolescent and adult patients with alopecia totalis and alopecia universalis

Article

Author: Magnolo, Nina ; Takiya, Liza ; Wajsbrot, Dalia ; Schaefer, Gregor ; Guttman‐Yassky, Emma ; Mesinkovska, Natasha ; King, Brett ; Wolk, Robert ; Sinclair, Rodney ; Cox, Lori Ann ; Banerjee, Anindita ; Kerkmann, Urs ; Peeva, Elena ; Mizuashi, Masato ; Zhang, Xingqi ; Law, Ernest ; Shapiro, Jerry

Abstract:

This post‐hoc analysis of the ALLEGRO phase 2b/3 study (NCT03732807) evaluated the efficacy and safety of ritlecitinib, an oral Janus kinase 3/TEC family kinase inhibitor, in patients with alopecia totalis (AT) and alopecia universalis (AU). Patients aged ≥ 12 years with alopecia areata (AA) and ≥50% scalp hair loss received once‐daily ritlecitinib 50 or 30 mg (± 4‐week 200‐mg loading dose) or placebo for 24 weeks. In a subsequent 24‐week extension period, the ritlecitinib groups continued their doses and patients initially assigned to placebo switched to ritlecitinib (200/50 or 50 mg daily). In this analysis, clinician‐ and patient‐reported hair regrowth outcomes were assessed at weeks 24 and 48 in four AA subgroups: AT/AU, AT, AU, and non‐AT/AU. Safety was monitored throughout. Of the 718 randomized patients, 151 (21%) and 147 (20%) were defined as having AT or AU, respectively. At week 24, Severity of Alopecia Tool (SALT) score ≤20 (≤20% scalp hair loss) response rates were higher in the ritlecitinib‐treated AT/AU, AT, and AU groups (7%–14%, 7%–21%, and 4%–10%, respectively) vs the placebo group (0% in the AT/AU, AT, and AU groups). The proportions of patients with a SALT score of ≤20 increased through week 48 (AT/AU, 13%–31%; AT, 11%–27%; AU, 6%–41%). Additionally, at week 24, 25%–43%, 32%–42%, and 12%–50% of patients with AT/AU, AT, and AU, respectively, who received ritlecitinib achieved a moderately or greatly improved response based on the Patient Global Impression of Change scale. Response rates generally increased through week 48 and were similar across AA subgroups. In patients with AT/AU, ritlecitinib was well tolerated with a safety profile consistent with that of the overall AA population. Ritlecitinib demonstrated clinical efficacy, patient‐reported improvement, and an acceptable safety profile in patients with AT and AU through week 48. A plain language summary of this study is available at https://doi-org.libproxy1.nus.edu.sg/10.25454/pfizer.figshare.26879161. Clinicaltrials.gov: NCT03732807.

News (Medical) associated with Ritlecitinib Tosilate

19 Nov 2024

·www.prnewswire.com

Celiac Disease Pipeline Grows as 25+ Key Pharma Companies Join the Fight for Innovative Treatments | DelveInsight

The growing comprehension of the pathogenesis of celiac disease has paved the way for the exploration of alternative treatment strategies. These novel approaches are aimed at addressing the condition at its root cause, targeting the underlying mechanisms that trigger the immune response in individuals with celiac disease. These innovative approaches hold the promise of transforming the landscape of celiac disease treatment in the near future. LAS VEGAS, Nov. 19, 2024 /PRNewswire/ -- DelveInsight's ' Celiac Disease Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline celiac disease therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the celiac disease pipeline domain. Key Takeaways from the Celiac Disease Pipeline Report DelveInsight's celiac disease pipeline report depicts a robust space with 25+ active players working to develop 30+ pipeline therapies for celiac disease treatment. Key celiac disease companies such as Takeda, Sanofi, Entero Therapeutics, Pfizer, Topas Therapeutics, Anokion SA, Protagonist Therapeutics, Equillium, Theriva Biologics, Chugai Pharmaceutical, Novartis, Immunic, Mozart Therapeutics, Nemysis Ltd, Barinthus Biotherapeutics, Parvus Therapeutics, Kallyope, AMYRA Biotech AG, Forte Biosciences, LAPIX Therapeutics, Ahead Therapeutics, Allero Therapeutics, STEMCELL Technologies, IM Therapeutics, Provid Pharmaceuticals, Sigmoid Pharma, Janssen Biotech, Inc., Lumen Bioscience, IGY Life Sciences, Ahead Therapeutics, ANTOLRX, Imcyse, and others are evaluating new celiac disease drugs to improve the treatment landscape. Promising Celiac Disease pipeline therapies such as TAK-101, TAK-062, PRV-015, Latiglutenase, TAK-227, Ritlecitinib, TPM-502, KAN 101, PTG-100, EQ 102, SYN-020, DONQ52, CALY-002, IMU-856, MTX-101, E 40-02, VTP-1000, PVT-301, Research Program: Celiac disease, AMY02, FB 102, LPX-TIGI, AT 1718, ALL-001, SQZ TACs, Research Program: small molecule therapeutics, Research Program: DQ2/8, Research Program: SmPillformulations, Research Program: autoimmune disease therapeutics, IgY-112, AT 1715, Research programme: Celiac disease, and others are under different phases of Celiac Disease clinical trials. In October 2024, Topas Therapeutics announced positive topline results from its Phase IIa trial of TPM502, in patients with celiac disease. The study data serves as the first clinical proof of concept for Topas' proprietary nanoparticle platform and its potential to induce targeted, antigen-specific tolerogenic effects. In September 2024, Barinthus Biotherapeutics plc, a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates that guide T cells to control disease, announced the initiation of its first-in-human Phase I trial of VTP-1000 in adults with coeliac disease. In May 2024, Entero Therapeutics, Inc. (formerly First Wave BioPharma, Inc.) unveiled its new corporate name and website. The rebranding follows the recent business combination with ImmunogenX and reflects the Company's focus on addressing unmet needs in GI health that include celiac disease, an indication for which there are no approved medicines today. In March 2024, First Wave BioPharma announced the acquisition of ImmunogenX in an all-stock transaction with the combined company focused on advancing a GI pipeline comprised of multiple, late-stage clinical assets, including latiglutenase, a potentially first-in-class, near Phase III-ready, targeted, oral biotherapeutic for celiac disease. In February 2024, with the approval of the SQZ transaction, STEMCELL acquired substantially all of SQZ's assets including its entire portfolio of over 400 patents and trademarks, other intellectual property such as copyrights and trade secrets, proprietary equipment, and its head license with the Massachusetts Institute of Technology. In January 2024, Calypso Biotech BV announced that it had entered into an agreement to be acquired by Novartis AG ('Novartis'). Calypso's shareholders received an upfront payment of $250 million upon closing and are eligible to receive development milestones of up to $175 million based on the achievement of certain predetermined milestones. The acquisition gives Novartis full rights to CALY-002. Novartis intends to further explore CALY-002 across a wide variety of autoimmune indications with high unmet medical needs. Request a sample and discover the recent advances in celiac disease treatment drugs @ Celiac Disease Pipeline Report The celiac disease pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage celiac disease drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the celiac disease clinical trial landscape. Celiac Disease Overview Celiac disease is a chronic autoimmune disorder triggered by the ingestion of gluten, a protein found in wheat, barley, and rye. In individuals with celiac disease, the immune system mistakenly attacks the small intestine upon gluten consumption, leading to inflammation and damage to the intestinal lining, specifically the villi, which are essential for nutrient absorption. The exact cause of celiac disease is not fully understood, but it is known to involve a combination of genetic predisposition (usually associated with HLA-DQ2 or HLA-DQ8 genes) and environmental factors. Common symptoms of celiac disease include digestive issues such as diarrhea, bloating, gas, constipation, and abdominal pain. However, some individuals experience non-digestive symptoms, like fatigue, anemia, joint pain, skin rashes, and even neurological issues such as headaches or depression. Because of this broad symptom range, celiac disease is often underdiagnosed or misdiagnosed as other conditions. Diagnosis typically involves blood tests to detect specific antibodies (like tissue transglutaminase antibodies) and, if positive, is followed by an intestinal biopsy to confirm damage to the villi. Genetic testing may also be conducted in some cases to identify predispositions. The primary treatment for celiac disease is a strict, lifelong gluten-free diet. By avoiding gluten, individuals with celiac disease can heal intestinal damage and prevent symptoms and complications. However, adherence to this diet requires vigilance, as even small amounts of gluten can trigger symptoms and damage. Find out more about celiac disease treatment drugs @ Drugs for Celiac Disease Treatment A snapshot of the Celiac Disease Pipeline Drugs mentioned in the report: Learn more about the emerging celiac disease pipeline therapies @ Celiac Disease Clinical Trials Celiac Disease Therapeutics Assessment The celiac disease pipeline report proffers an integral view of the celiac disease emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Celiac Disease Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action: Gliadin inhibitors, Gluten modulators, Transglutaminase 2 inhibitors, Emt protein-tyrosine kinase inhibitors, Janus kinase 3 inhibitors, Alpha4beta7 integrin antagonists, Interleukin 15 inhibitors, Interleukin 21 inhibitors, Alkaline phosphatase replacements, HLA-DQ antigen inhibitors Key Celiac Disease Companies: Takeda, Sanofi, Entero Therapeutics, Pfizer, Topas Therapeutics, Anokion SA, Protagonist Therapeutics, Equillium, Theriva Biologics, Chugai Pharmaceutical, Novartis, Immunic, Mozart Therapeutics, Nemysis Ltd, Barinthus Biotherapeutics, Parvus Therapeutics, Kallyope, AMYRA Biotech AG, Forte Biosciences, LAPIX Therapeutics, Ahead Therapeutics, Allero Therapeutics, STEMCELL Technologies, IM Therapeutics, Provid Pharmaceuticals, Sigmoid Pharma, Janssen Biotech, Inc., Lumen Bioscience, IGY Life Sciences, Ahead Therapeutics, ANTOLRX, Imcyse, and others. Key Celiac Disease Pipeline Therapies: TAK-101, TAK-062, PRV-015, Latiglutenase, TAK-227, Ritlecitinib, TPM-502, KAN 101, PTG-100, EQ 102, SYN-020, DONQ52, CALY-002, IMU-856, MTX-101, E 40-02, VTP-1000, PVT-301, Research Program: Celiac disease, AMY02, FB 102, LPX-TIGI, AT 1718, ALL-001, SQZ TACs, Research Program: small molecule therapeutics, Research Program: DQ2/8, Research Program: SmPillformulations, Research Program: autoimmune disease therapeutics, IgY-112, AT 1715, Research programme: Celiac disease, and others. Dive deep into rich insights for new drugs for celiac disease treatment, visit @ Celiac Disease Drugs Table of Contents For further information on the celiac disease pipeline therapeutics, reach out @ Celiac Disease Treatment Drugs Related Reports Celiac Disease Epidemiology Celiac Disease Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted celiac disease epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Celiac Disease Market Celiac Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key celiac disease companies including Entero Therapeutics, Amgen, Provention Bio, Takeda, among others. Sjogren's Syndrome Market Sjogren's Syndrome 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 Sjogren's syndrome companies including Horizon Therapeutics (Amgen), Dompe Farmaceutici, Sylentis, MorphoSys, Resolve Therapeutics, OSE Immunotherapeutics, Servier, Novartis, Johnson & Johnson , among others. Sjogren's Syndrome Pipeline Sjogren's Syndrome Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Sjogren's syndrome companies, including Novartis, Horizon Therapeutics, Bristol-Myers Squibb, Rise Therapeutics, Resolve Therapeutics, Dompe Farmaceutici, 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

Clinical ResultPhase 2AcquisitionPhase 1Immunotherapy

25 Oct 2024

·www.prnewswire.com

Sun Pharma Presents LEQSELVI™ (deuruxolitinib) Data Highlighting Clinical Efficacy & Durability for Treatment of Alopecia Areata at the 2024 Fall Clinical Dermatology Conference

Data at 68 weeks of treatment with LEQSELVI showed ongoing and clinically meaningful improvement in scalp hair regrowth Study finds that doctors and patients prefer fast time to onset and proven efficacy in JAK inhibitor options, regardless of dosing schedule MUMBAI, India and PRINCETON, N.J., Oct. 25, 2024 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, together with its subsidiaries and/or affiliated companies, "Sun Pharma") today presented new data highlighting the clinical efficacy and safety of LEQSELVI™ (deuruxolitinib) 8 mg tablets at the 44th Annual Fall Clinical Dermatology Conference, being held October 24-27, 2024, in Las Vegas, Nevada. LEQSELVI 8 mg tablets was approved by the U.S. Food and Drug Administration for the treatment of adults with severe alopecia areata (AA) earlier this year. LEQSELVI, a JAK inhibitor, treats alopecia areata at the source and is clinically proven to deliver statistically significant efficacy. LEQSELVI data presented at Fall Clinical includes pooled long-term results from open-label extension (OLE) studies showing ongoing and clinically meaningful improvements in scalp hair regrowth in adults with AA taking LEQSELVI for up to 68 weeks. To determine long-term efficacy, the Severity of Alopecia Tool (SALT) scores were analyzed using two methods: Last Observation Carried Forward (LOCF) and As Observed (AO). At the end of the qualifying trial period at Week 24, 32.6% of patients receiving LEQSELVI 8 mg BID (twice daily) achieved a SALT ≤20 score; the percentage of SALT 20 responders increased to 48.8% (LOCF analysis) and 76.6% (AO analysis) at Week 68 of the OLE studies. Additionally, 99.6% (282 patients) maintained their response to LEQSELVI 8 mg BID (as defined by sustaining a SALT ≤50 after achieving SALT ≤20 during the OLE studies as of the cutoff date). "This research provides insight into the durability of response experienced with LEQSELVI 8 mg twice daily, adding to a growing body of evidence highlighting the benefits of this treatment for those living with severe alopecia areata," said Brett King, MD, PhD. "These data highlight an important role for deuruxolitinib in the care of patients living with this disease." In addition to the OLE study, two posters presented at Fall Clinical capture patient and clinician feedback for the treatment of AA which confirm the preference for treatment options with fast time to onset and proven efficacy, irrespective of dosing schedules. In the blinded treatment scenario displaying profiles of LEQSELVI, baricitinib and ritlecitinib, patients and clinicians chose the profile of LEQSELVI as the preferred therapeutic option. "As we continue to grow the Sun Pharma dermatology portfolio, the data presented at Fall Clinical support a growing body of clinical evidence, which show LEQSELVI is an effective treatment option for those living with severe alopecia areata," said Marek Honczarenko, MD, PhD, Senior Vice President and Head of Global Development at Sun Pharma. "We're excited to share these important data with the dermatology community and look forward to seeing patients living with alopecia areata access this innovative treatment option." LEQSELVI may cause serious side effects including serious infections, malignancies, thrombosis, gastrointestinal perforations, and certain laboratory abnormalities. There also may be an increased risk of mortality and major cardiovascular events. LEQSELVI should not be used in patients who are CYP2C9 poor metabolizers or who are taking moderate or strong CYP2C9 inhibitors. In placebo-controlled trials, the three most common adverse events were headache (12.4% as compared to 9.4% with placebo), acne (10% as compared to 4.3% with placebo), and nasopharyngitis (8.1% as compared to 6.7% with placebo). Please see full Prescribing Information, including BOXED WARNING and Medication Guide, and see below for Important Safety Information. For more information about LEQSELVI, visit LEQSELVI.com. About LEQSELVI™ and alopecia areata LEQSELVI (deuruxolitinib) 8 mg tablets is an oral selective inhibitor of Janus kinases JAK1 and JAK2 approved for the treatment of adult patients with severe alopecia areata. Alopecia areata is an autoimmune disease in which the immune system attacks hair follicles, resulting in partial or complete loss of hair on the scalp and body. Alopecia areata may affect up to 2.5% of the United States and global population during their lifetime.1,2,3 The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life and affects both women and men. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. There are currently limited approved treatment options available for alopecia areata. LEQSELVI Important Safety Information Please click here for full Prescribing Information Including BOXED WARNING and Medication Guide. Indications and Usage LEQSELVI (deuruxolitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with severe alopecia areata. Limitations of Use LEQSELVI is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. Contraindications LEQSELVI is contraindicated in patients who are CYP2C9 poor metabolizers or who are using moderate or strong CYP2C9 inhibitors. Warnings Serious Infections Increased risk of serious bacterial, fungal, viral and opportunistic infections including tuberculosis (TB) that may lead to hospitalization or death. Interrupt treatment with LEQSELVI if a serious infection occurs until the infection is controlled. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test. Mortality Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. LEQSELVI is not approved for use in RA patients. Malignancy Malignancies have occurred in patients treated with LEQSELVI. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients. Major Adverse Cardiovascular Events Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. Thrombosis Thrombosis, including PE, DVT & CVT, has occurred in patients treated with LEQSELVI. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers. Increased risk of serious adverse reactions in CYP2C9 poor metabolizers or with concomitant use of moderate or strong CYP2C9 inhibitors Do not treat patients who are CYP2C9 poor metabolizers or patients taking a moderate or strong CYP2C9 inhibitor with LEQSELVI. Gastrointestinal Perforations GI perforations have occurred in patients treated with LEQSELVI. Monitor patients who may be at increased risk for gastrointestinal perforation. Evaluate promptly patients presenting with new onset abdominal symptoms. Lipid elevations, anemia, neutropenia, and lymphopenia Monitor for changes in lipids, hemoglobin, neutrophils, and lymphocytes. Immunizations Avoid use of live vaccines during or immediately prior to LEQSELVI treatment. Prior to initiating LEQSELVI, it is recommended that patients be brought up to date with all immunizations. Dosage The recommended dosage of LEQSELVI for the treatment of severe alopecia areata is 8 mg orally twice daily, with or without food. Before treatment with LEQSELVI, perform the following evaluations: CYP2C9 genotype & use of moderate or strong CYP2C9 inhibitors; Active and latent tuberculosis evaluation; Viral hepatitis screening; Complete blood count (LEQSELVI treatment is not recommended in patients with an absolute lymphocyte count (ALC) <500 cells/mm3 absolute neutrophil count (ANC) <1,000 cells/mm3, or hemoglobin level <8 g/dl). Adverse Reactions Most common adverse reactions (≥1%) are headache, acne, nasopharyngitis, blood creatine phosphokinase increased, hyperlipidemia, fatigue, weight increased, lymphopenia, thrombocytosis, anemia, skin and soft tissue infections, neutropenia, and herpes. Use in Specific Populations Based on animal studies, LEQSELVI may cause fetal harm during pregnancy. Pregnant women should be advised of a risk to the fetus. Consider pregnancy planning and prevention for women of reproductive potential. LEQSELVI should not be used by women who are breastfeeding until one day after the last dose. LEQSELVI should not be used by patients with severe renal impairment or severe hepatic impairment. References Benigno M. A Large Cross-Sectional Survey Study of the Prevalence of alopecia areata in the United States, Clinical, Cosmetic and Investigational Dermatology 2020. Lee HH et al. Epidemiology of alopecia areata, ophiasis, totalis, and universalis: A systematic review and meta-analysis, J Am Acad Dermatol. 2020 Mar; 82(3): 675-682. Fricke et al. Epidemiology and burden of alopecia areata: a systematic review, Clin Cosmet Investig Dermatol. 2015 Jul 24;8: 397-403. About Sun Pharmaceutical Industries Limited. (CIN – L24230GJ1993PLC019050) Sun Pharma is the world's leading specialty generics company with a presence in Specialty, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the US as well as Global Emerging Markets. Sun's high growth Global Specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multi-cultural workforce drawn from over 50 nations. For further information, please visit and follow us on LinkedIn & X (Formerly Twitter). Disclaimer: Statements in this "document" describing the Company's objectives, projections, estimates, expectations, plans or predictions, industry conditions, or events may be "forward-looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance, or achievements could differ materially from those expressed or implied. The Company undertakes any obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. Contacts: Sun Pharma SOURCE Sun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug Approval

25 Oct 2024

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Sun Pharma Presents LEQSELVI™ (deuruxolitinib) Data Highlighting Clinical Efficacy & Durability for Treatment of Alopecia Areata at the 2024 Fall Clinical Dermatology Conference

Data at 68 weeks of treatment with LEQSELVI showed ongoing and clinically meaningful improvement in scalp hair regrowth Study finds that doctors and patients prefer fast time to onset and proven efficacy in JAK inhibitor options, regardless of dosing schedule MUMBAI, India and PRINCETON, N.J. , Oct. 25, 2024 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, together with its subsidiaries and/or affiliated companies, “Sun Pharma”) today presented new data highlighting the clinical efficacy and safety of LEQSELVI™ (deuruxolitinib) 8 mg tablets at the 44 th Annual Fall Clinical Dermatology Conference, being held October 24-27, 2024 , in Las Vegas, Nevada . LEQSELVI 8 mg tablets was approved by the U.S. Food and Drug Administration for the treatment of adults with severe alopecia areata (AA) earlier this year. LEQSELVI, a JAK inhibitor, treats alopecia areata at the source and is clinically proven to deliver statistically significant efficacy. LEQSELVI data presented at Fall Clinical includes pooled long-term results from open-label extension (OLE) studies showing ongoing and clinically meaningful improvements in scalp hair regrowth in adults with AA taking LEQSELVI for up to 68 weeks. To determine long-term efficacy, the Severity of Alopecia Tool (SALT) scores were analyzed using two methods: Last Observation Carried Forward (LOCF) and As Observed (AO). At the end of the qualifying trial period at Week 24, 32.6% of patients receiving LEQSELVI 8 mg BID (twice daily) achieved a SALT ≤20 score; the percentage of SALT 20 responders increased to 48.8% (LOCF analysis) and 76.6% (AO analysis) at Week 68 of the OLE studies. Additionally, 99.6% (282 patients) maintained their response to LEQSELVI 8 mg BID (as defined by sustaining a SALT ≤50 after achieving SALT ≤20 during the OLE studies as of the cutoff date). “This research provides insight into the durability of response experienced with LEQSELVI 8 mg twice daily, adding to a growing body of evidence highlighting the benefits of this treatment for those living with severe alopecia areata,” said Brett King , MD, PhD. “These data highlight an important role for deuruxolitinib in the care of patients living with this disease.” In addition to the OLE study, two posters presented at Fall Clinical capture patient and clinician feedback for the treatment of AA which confirm the preference for treatment options with fast time to onset and proven efficacy, irrespective of dosing schedules. In the blinded treatment scenario displaying profiles of LEQSELVI, baricitinib and ritlecitinib, patients and clinicians chose the pro LEQSELVI as the preferred therapeutic option. “As we continue to grow the Sun Pharma dermatology portfolio, the data presented at Fall Clinical support a growing body of clinical evidence, which show LEQSELVI is an effective treatment option for those living with severe alopecia areata,” said Marek Honczarenko , MD, PhD, Senior Vice President and Head of Global Development at Sun Pharma. “We’re excited to share these important data with the dermatology community and look forward to seeing patients living with alopecia areata access this innovative treatment option.” LEQSELVI may cause serious side effects including serious infections, malignancies, thrombosis, gastrointestinal perforations, and certain laboratory abnormalities. There also may be an increased risk of mortality and major cardiovascular events. LEQSELVI should not be used in patients who are CYP2C9 poor metabolizers or who are taking moderate or strong CYP2C9 inhibitors. In placebo-controlled trials, the three most common adverse events were headache (12.4% as compared to 9.4% with placebo), acne (10% as compared to 4.3% with placebo), and nasopharyngitis (8.1% as compared to 6.7% with placebo). Please see full Prescribing Information , including BOXED WARNING and Medication Guide, and see below for Important Safety Information. For more information about LEQSELVI, visit LEQSELVI.com . About LEQSELVI™ and alopecia areata LEQSELVI (deuruxolitinib) 8 mg tablets is an oral selective inhibitor of Janus kinases JAK1 and JAK2 approved for the treatment of adult patients with severe alopecia areata. Alopecia areata is an autoimmune disease in which the immune system attacks hair follicles, resulting in partial or complete loss of hair on the scalp and body. Alopecia areata may affect up to 2.5% of the United States and global population during their lifetime. 1,2,3 The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life and affects both women and men. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. There are currently limited approved treatment options available for alopecia areata. LEQSELVI Important Safety Information Please click here for full Prescribing Information Including BOXED WARNING and Medication Guide. Indications and Usage LEQSELVI (deuruxolitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with severe alopecia areata. Limitations of Use LEQSELVI is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. Contraindications LEQSELVI is contraindicated in patients who are CYP2C9 poor metabolizers or who are using moderate or strong CYP2C9 inhibitors. Warnings Serious Infections Increased risk of serious bacterial, fungal, viral and opportunistic infections including tuberculosis (TB) that may lead to hospitalization or death. Interrupt treatment with LEQSELVI if a serious infection occurs until the infection is controlled. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test. Mortality Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. LEQSELVI is not approved for use in RA patients. Malignancy Malignancies have occurred in patients treated with LEQSELVI. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients. Major Adverse Cardiovascular Events Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. Thrombosis Thrombosis, including PE, DVT & CVT, has occurred in patients treated with LEQSELVI. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers. Increased risk of serious adverse reactions in CYP2C9 poor metabolizers or with concomitant use of moderate or strong CYP2C9 inhibitors Do not treat patients who are CYP2C9 poor metabolizers or patients taking a moderate or strong CYP2C9 inhibitor with LEQSELVI. Gastrointestinal Perforations GI perforations have occurred in patients treated with LEQSELVI. Monitor patients who may be at increased risk for gastrointestinal perforation. Evaluate promptly patients presenting with new onset abdominal symptoms. Lipid elevations, anemia, neutropenia, and lymphopenia Monitor for changes in lipids, hemoglobin, neutrophils, and lymphocytes. Immunizations Avoid use of live vaccines during or immediately prior to LEQSELVI treatment. Prior to initiating LEQSELVI, it is recommended that patients be brought up to date with all immunizations. Dosage The recommended dosage of LEQSELVI for the treatment of severe alopecia areata is 8 mg orally twice daily, with or without food. Before treatment with LEQSELVI, perform the following evaluations: CYP2C9 genotype & use of moderate or strong CYP2C9 inhibitors; Active and latent tuberculosis evaluation; Viral hepatitis screening; Complete blood count (LEQSELVI treatment is not recommended in patients with an absolute lymphocyte count (ALC) <500 cells/mm3 absolute neutrophil count (ANC) <1,000 cells/mm3, or hemoglobin level <8 g/dl). Adverse Reactions Most common adverse reactions (≥1%) are headache, acne, nasopharyngitis, blood creatine phosphokinase increased, hyperlipidemia, fatigue, weight increased, lymphopenia, thrombocytosis, anemia, skin and soft tissue infections, neutropenia, and herpes. Use in Specific Populations Based on animal studies, LEQSELVI may cause fetal harm during pregnancy. Pregnant women should be advised of a risk to the fetus. Consider pregnancy planning and prevention for women of reproductive potential. LEQSELVI should not be used by women who are breastfeeding until one day after the last dose. LEQSELVI should not be used by patients with severe renal impairment or severe hepatic impairment. References Benigno M. A Large Cross-Sectional Survey Study of the Prevalence of alopecia areata in the United States , Clinical, Cosmetic and Investigational Dermatology 2020. Lee HH et al. Epidemiology of alopecia areata, ophiasis, totalis, and universalis: A systematic review and meta-analysis, J Am Acad Dermatol . 2020 Mar; 82(3): 675-682. Fricke et al. Epidemiology and burden of alopecia areata: a systematic review, Clin Cosmet Investig Dermatol . 2015 Jul 24;8: 397-403. About Sun Pharmaceutical Industries Limited. (CIN – L24230GJ1993PLC019050) Sun Pharma is the world’s leading specialty generics company with a presence in Specialty, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the US as well as Global Emerging Markets. Sun’s high growth Global Specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company’s vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multi-cultural workforce drawn from over 50 nations. For further information, please visit and follow us on LinkedIn & X (Formerly Twitter). Disclaimer: Statements in this “document” describing the Company’s objectives, projections, estimates, expectations, plans or predictions, industry conditions, or events may be “forward-looking statements” within the meaning of applicable securities laws and regulations. Actual results, performance, or achievements could differ materially from those expressed or implied. The Company undertakes any obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. Contacts: Sun Pharma Investors: Dr. Abhishek Sharma Tel + 91 22 4324 4324, Ext 2929 Tel Direct + 91 22 43242929 Mobile + 91 98196 86016 E mail abhi.sharma@sunpharma.com US Contact: Media: James Freeman Office: (609) 720-8197 Mobile: (978) 808-6956 Email: james.freeman@sunpharma.com Media: Gaurav Chugh Tel +91 22 4324 4324, Ext 5373 Tel Direct +91 22 4324 5373 Mobile +91 98104 71414 E mail gaurav.chugh@sunpharma.com View original content to download multimedia: SOURCE Sun Pharma

Clinical ResultDrug Approval

100 Deals associated with Ritlecitinib Tosilate

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Approved

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Indication	Country/Location	Organization	Date
Alopecia Areata	US	Pfizer Inc.	23 Jun 2023

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Indication	Highest Phase	Country/Location	Organization	Date
Nonsegmental vitiligo	Phase 3	US	Pfizer Inc.	01 Dec 2022
Nonsegmental vitiligo	Phase 3	CN	Pfizer Inc.	01 Dec 2022
Nonsegmental vitiligo	Phase 3	JP	Pfizer Inc.	01 Dec 2022
Nonsegmental vitiligo	Phase 3	AU	Pfizer Inc.	01 Dec 2022
Nonsegmental vitiligo	Phase 3	BG	Pfizer Inc.	01 Dec 2022
Nonsegmental vitiligo	Phase 3	CA	Pfizer Inc.	01 Dec 2022
Nonsegmental vitiligo	Phase 3	DE	Pfizer Inc.	01 Dec 2022
Nonsegmental vitiligo	Phase 3	IN	Pfizer Inc.	01 Dec 2022
Nonsegmental vitiligo	Phase 3	IT	Pfizer Inc.	01 Dec 2022
Nonsegmental vitiligo	Phase 3	MX	Pfizer Inc.	01 Dec 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03395184 (CTgov)	Phase 2	Crohn Disease	244	Placebo (Induction Period: Placebo QD)	hwldlqpupk(tmbefmzfrw) = xadrlizkdi wiabzbalgr (gxifguqyyh, nabmuhnsey - evccuqlkeq) View more	-	30 Oct 2024
				Ritlecitinib (Induction Period: Ritlecitinib 200 mg/50 mg QD)	hwldlqpupk(tmbefmzfrw) = iztselbjit wiabzbalgr (gxifguqyyh, xztcgqdneh - raqbahyirs) View more
NCT03732807 (ALLEGRO, Pubmed \| Am J Clin Dermatol)	Phase 2/3	Alopecia Areata	718	Ritlecitinib 50 mg	cmohwlgsbl(szxcywappn) = ajyudwhvcf airgbggwiz (yjoczwovvc )	Positive	23 Oct 2024
				Ritlecitinib 30 mg	cmohwlgsbl(szxcywappn) = xkycltvxon airgbggwiz (yjoczwovvc )
NCT03732807 \| NCT04006457 (ALLEGRO-2b/3 \| ALLEGRO Phase 2b/3 \| ALLEGRO phase 2b/3 study \| ALLEGRO, Pubmed \| Br J Dermatol) Manual	Phase 2/3	Alopecia Areata	385	Ritlecitinib 50 mg	awwqemhtgp(jwgbctwudl) = zcevqzqrwp jdjbzjshee (oftgubfrql ) View more	Positive	21 Oct 2024
				Ritlecitinib 200/50 mg	awwqemhtgp(jwgbctwudl) = sivoedcvax jdjbzjshee (oftgubfrql ) View more
NCT05650333 (CTgov)	Phase 1	Alopecia Areata	15	Ritlecitinib 20 mg	wabbympgrh(qmmlvdgvrj) = ejfnedttdh iglxiqigjv (gqbgcwuwud, ujgizloass - cuyswxahmo) View more	-	08 Oct 2024
NCT03732807 (ALLEGRO phase 2b/3, Pubmed \| Dermatol Ther (Heidelb))	Phase 2/3	Alopecia Areata	522	Ritlecitinib 30 mg	dvdwwsgnhq(hfygwjletn): OR = 2.12 (95% CI, 1.23 - 3.65), P-Value = < 0.05	Positive	10 Sep 2024
				Ritlecitinib 50 mg
NCT05128058 (CTgov)	Phase 1	-	16	RITLECITINIB (RITLECITINIB 50 MG CAPSULE)	phdqpjyfcz(mfkykixauz) = oslvnwzzzo xiwohceqhg (szijboxbsj, okokjxrota - sdhhjuardp) View more	-	13 Nov 2023
				RITLECITINIB (RITLECITINIB 200 MG CAPSULE)	phdqpjyfcz(mfkykixauz) = nzatvuunyy xiwohceqhg (szijboxbsj, riyvmhdmbr - srbfevbdnq) View more
NCT03732807 (ALLEGRO phase 2b/3, EADV2023)	Phase 2/3	Alopecia Areata	191	Ritlecitinib 50mg QD	nbmrymurjo(eoegclhhgv) = mxxsnubeus gzgxeuomnd (lzqfhjtmlq ) View more	-	11 Oct 2023
NCT04006457 (ALLEGRO-LT, EADV2023)	Phase 3	Alopecia Areata	447	Ritlecitinib 200 mg	bnrkvtpwmw(wyatftagtb) = awzdikdxhw homtvxfdih (tjvwyadjkp ) View more	-	11 Oct 2023
				Ritlecitinib 50 mg	bnrkvtpwmw(wyatftagtb) = xhbuxcznab homtvxfdih (tjvwyadjkp ) View more
NCT05040295 (CTgov)	Phase 1	-	12	Ritlecitinib (Treatment A: Ritlecitinib 30 mg Intact Adult Capsule)	pqtsqquate(gkpcyarsgh) = xegzoauffm rvlupfsngs (kynzxjbjrj, gsvuunvbxd - iskldrdrgt) View more	-	21 Aug 2023
				Ritlecitinib (Treatment B: Ritlecitinib 3*10 mg Pediatric Capsules)	pqtsqquate(gkpcyarsgh) = gdcqmhsner rvlupfsngs (kynzxjbjrj, cgdunwocny - rmascudicc) View more
NCT03732807 (ALLEGRO, WCD 12023 \| WCD 22023) Manual	Phase 2/3	Alopecia Areata	718	Ritlecitinib 50 mg	qazvipuohr(zgxovwqmak) = lyvvdeqaue osdxrfomhd (ijaesxtcle ) View more	Positive	06 Jul 2023
				Ritlecitinib 200 mg + 50 mg	qazvipuohr(zgxovwqmak) = mosnlucyqv osdxrfomhd (ijaesxtcle ) View more

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