Sun Pharma discontinues development of skin disease drug after trials failure
Mumbai: Sun Pharmaceutical Industries Limited has announced the discontinuation of two clinical trials evaluating SCD-044, a novel, orally bioavailable sphingosine-1- phosphate (S1P) receptor 1 agonist, for moderate to severe psoriasis and atopic dermatitis.
This came after top-line results from the Phase 2 clinical trial did not meet its primary endpoint of 75% improvement in PASI (Psoriasis Area and Severity Index) score (≥PASI75) and EASI (Eczema Area and Severity Index) score (≥EASI75) 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. The Phase 2 atopic dermatitis study of SCD-044 included 250 people and compared three different dosages of SCD-044 with placebo.
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"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," the release stated.
“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.
