Sun Pharmaceutical Industries Limited 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 per cent 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 per cent 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 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.