Sun Pharma ends development of oral skin drug SCD-044 after trial failures

In a setback for its research pipeline, pharmaceutical major Sun Pharmaceutical Industries has announced that its experimental drug, SCD-044, failed to meet its primary endpoints in two mid-stage (Phase 2) clinical trials for moderate to severe psoriasis and atopic dermatitis (eczema), following which the company has decided to discontinue its development.

Sun Pharma stated that the Phase 2 clinical trial evaluating the safety and efficacy of SCD-044 for moderate to severe psoriasis (a chronic autoimmune skin condition) did not achieve its primary endpoint of a 75% improvement in the PASI (Psoriasis Area and Severity Index) score (≥PASI75) at Week 16. This randomised, double-blind, placebo-controlled study included 263 individuals with moderate to severe plaque psoriasis.

The company is also discontinuing studies of SCD-044 for atopic dermatitis (a chronic inflammatory skin condition). The top-line results from its Phase 2 clinical trial for this condition similarly did not meet the primary objective of a 75% improvement in the EASI (Eczema Area and Severity Index) score (≥EASI75) at Week 16. The atopic dermatitis study of SCD-044 involved 250 participants and compared three different dosages of the drug with a 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.

Despite the disappointing efficacy results, Sun Pharma clarified no major safety or tolerability concerns were identified with SCD-044 in either the plaque psoriasis or atopic dermatitis studies.

Following these outcomes, Sun Pharma has decided to discontinue further clinical trials of SCD-044 and has no plans for its continued development. The company and its partner, Sun Pharma Advanced Research Company Ltd., will now evaluate the appropriate next steps for the asset.

SCD-044 is an oral pill designed to treat inflammatory skin diseases like atopic dermatitis and psoriasis by targeting immune cells. The company previously stated that S1P receptor 1 agonists are promising for treating autoimmune inflammatory diseases due to their ability to modulate the migration of lymphocytes out of lymphatic tissue.

A Phase 1 study of SCD-044 in healthy volunteers had shown lymphocyte count reduction, a surrogate marker of efficacy for S1P receptor 1 agonists, at all evaluated dose levels.

Sun Pharmaceutical shares closed 0.43% at Rs 1667.65 on the BSE today.

The Mumbai-based pharmaceutical giant's net profit saw a 19% year-on-year fall in its Q4FY25 (January-March quarter) consolidated net profit at Rs 2,154 crore against Rs 2,659 crore profit in the year-ago period. The company's revenue grew 8% at Rs 12,959 crore in the said quarter over revenue worth Rs 11,983 crore in the year-ago period.