Mumbai: Sun Pharmaceutical Industries Limited today announced that the company 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 SCD044, which is being evaluated as a potential oral treatment for psoriasis, atopic dermatitis and other auto-immune disorders.
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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.
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