drugset / Press release

Sun Pharma Announces Top-Line Results from the Phase 2 Clinical Trials Evaluating SCD-044 for Moderate to Severe Psoriasis and Atopic Dermatitis

2025-06-03 · Sun Pharmaceutical Industries, Inc. · original sunpharma.com ↗

Sun Pharmaceutical Industries Limited SUN HOUSE, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, India Tel.: (91-22) 4324 4324 Fax.: (91-22) 4324 4343 Website: www.sunpharma.com Email: [email protected] CIN: L24230GJ1993PLC019050 Registered Office: SPARC, Tandalja, Vadodara – 390 012, Gujarat, INDIA Reaching People. Touching Lives FOR IMMEDIATE RELEASE Sun Pharma Announces Top-Line Results from the Phase 2 Clinical Trials Evaluating SCD-044 for Moderate to Severe Psoriasis and Atopic Dermatitis PRINCETON, NJ and MUMB AI, India, June 03 , 2025 -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or associated companies, “Sun Pharma”)) today announced top-line results from the Phase 2 clinical trial evaluating the safety and efficacy of SCD -044 (a novel, orally bioavailable sphingosine-1- phosphate (S1P) receptor 1 agonist) for moderate to severe psoriasis. The study did not meet its primary endpoint of 75% improvement in PASI (Psoriasis Area and Severity Index) score (≥PASI75) at Week 16. The Phase 2 randomized, double -blind, placebo-controlled study of SCD-044 included 263 people living with moderate to severe plaque psoriasis. Sun Pharma is also discontinuing studies of SCD -044 for atopic dermatitis after top -line results from a Phase 2 clinical trial did not meet the primary objective of 75% improvement in EASI (Eczema Area and Severity Index) score (≥EASI75) at Week 16. The Phase 2 atopic dermatitis study of SCD -044 included 250 people and compared three different dosages of SCD-044 with placebo. “While we are disappointed with the top -line results of the clinical trial s, we would like to thank all the psoriasis and atopic dermatitis patients, the healthcare professionals and administrators who participated in these pivotal clinical trials,” said Marek Honczarenko, MD, PhD, Senior Vice President and Head of Global Specialty Development at Sun Pharma. There were no major safety or tolerability concerns with SCD -044 in either the plaque psoriasis or atopic dermatitis studies. Sun Pharma is discontinuing clinical trials of the asset and has no further plans for development of SCD-044. Sun Pharma and its partner, Sun Pharma Advanced Research Company Ltd., will evaluate the appropriate next steps for SCD-044. About SCD-044 SCD-044 is a novel orally bioavailable S1P receptor 1 agonist for the treatment of inflammatory diseases such as atopic dermatitis and psoriasis. S1P receptor 1 agonists are promising for the treatment of autoimmune inflammatory diseases as they modulate migration of lymphocytes out of lymphatic tissue. This results in a decrease of circulating pathogenic lymphocytes, thereby reducing inflammation. A Phase 1 study of SCD-044 was completed in healthy volunteers earlier. This study established clinical proof-of- concept for SCD-044 in terms of its safety and pharmacodynamic effects. Lymphocyte count reduction, a surrogate marker of efficacy for S1P receptor 1 agonists, was observed at all dose levels evaluated. 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 i n the U.S. as well as global emerging markets. Sun Pharma’s high -growth global specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts Sun Pharmaceutical Industries Limited SUN HOUSE, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, India Tel.: (91-22) 4324 4324 Fax.: (91-22) 4324 4343 Website: www.sunpharma.com Email: [email protected] CIN: L24230GJ1993PLC019050 Registered Office: SPARC, Tandalja, Vadodara – 390 012, Gujarat, INDIA Reaching People. Touching Lives 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 multicultural workforce drawn from over 50 nations. For furthe r information, please visit www.sunpharma.com and follow us on LinkedIn & X (Formerly Twitter). Sun Pharma Contacts: Investors Dr. Abhishek Sharma +91 22 4324 2929 [email protected] Media (Global) Gaurav Chugh +91 22 4324 5373 [email protected] Media (USA) James Freeman +1 978-808-6956 [email protected]

The release as fetched from its publisher. sunpharma.com ↗