Sun Pharma ends development of SCD-044 after phase 2 trials fail to meet primary endpoints

 Sun Pharmaceutical Industries (along with its subsidiaries and associated companies, “Sun Pharma”) has announced top-line results from two Phase 2 clinical trials evaluating the safety and efficacy of SCD-044, an orally bioavailable sphingosine-1-phosphate (S1P) receptor 1 agonist, in the treatment of moderate to severe psoriasis and atopic dermatitis.

The Phase 2 randomised, double-blind, placebo-controlled trial for moderate to severe plaque psoriasis involved 263 participants. The trial did not meet its primary endpoint, which was achieving a 75 per cent improvement in the Psoriasis Area and Severity Index (≥PASI75) at Week 16.

In parallel, Sun Pharma has also announced the discontinuation of SCD-044 development for atopic dermatitis. The decision follows the results of another Phase 2 trial involving 250 participants, which tested three dosages of SCD-044 against placebo. This trial also did not meet its primary endpoint of 75 per cent improvement in the Eczema Area and Severity Index (≥EASI75) at Week 16.

Marek Honczarenko, MD, PhD, Senior Vice President and Head of Global Specialty Development at Sun Pharma, 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.”

There were no major safety or tolerability concerns observed with SCD-044 in either of the studies. Sun Pharma has announced that it will discontinue all clinical trials related to SCD-044 and has no further plans for its development. The company and its partner, Sun Pharma Advanced Research Company, will assess next steps for the compound.

SCD-044 is an orally administered S1P receptor 1 agonist initially developed for inflammatory conditions such as psoriasis and atopic dermatitis. S1P receptor 1 agonists work by modulating lymphocyte migration out of lymphatic tissues, leading to reduced circulation of pathogenic lymphocytes and lower inflammation. A Phase 1 study of SCD-044 previously conducted in healthy volunteers established proof-of-concept for its safety and pharmacodynamic effects, including lymphocyte count reduction, a surrogate marker of efficacy for this drug class.