Sun Pharma is discontinuing clinical trials of SCD-044 for psoriasis and has no further plans for development.
Source: sunpharma.com
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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 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.
The phase 2 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.
“While we are disappointed with the top-line results of the clinical trials, 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.
Source: sunpharma.com