Sun Pharma announces initiation of Phase 2 Clinical Trial of SCD-044 in Patients with Moderate to Severe Plaque Psoriasis

MUMBAI, India I January 04, 2021 I Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) today announced that it has initiated Phase 2 clinical trial for SCD-044 (a novel, orally bioavailable sphingosine-1-phosphate (S1P) receptor 1 agonist) in patients with moderate to severe plaque psoriasis.

The Phase 2 study is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of SCD-044 in the treatment of moderate to severe plaque psoriasis. The study will enroll approximately 240 subjects and topline results are expected in 2022.

SCD-044 is also being evaluated in other autoimmune disorders and Phase 2 studies for other indications like atopic dermatitis, are also expected to be initiated soon.

In May-2020, Sun Pharma entered into a worldwide in-licensing agreement with Sun Pharma Advanced Research Company Ltd. (SPARC) for the development and commercialization of SCD-044, which is being evaluated as a potential oral treatment for psoriasis, atopic dermatitis and other auto-immune disorders.

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 cause diminished migration of lymphocytes out of lymphatic tissue. This results in a decrease of circulating lymphocytes, thereby reducing inflammation.

A Phase 1 study of SCD-044 has been completed in healthy volunteers. 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 fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company. A vertically integrated business and a skilled team enables it to deliver high- quality products, trusted by customers and patients in over 100 countries across the world, at affordable prices. Its global presence is supported by manufacturing facilities spread across 6 continents and approved by multiple regulatory agencies, coupled with a multi-cultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities across multiple R&D centers, with investments of approximately 6% of annual revenues in R&D. For further information, please visit www.sunpharma.com & follow us on Twitter @SunPharma_Live.

SOURCE: Sun Pharma

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