Sun Pharma Announces Phase 2 Trial Results for SCD-044: Primary Endpoint Not Met

Sun Pharmaceutical Industries Ltd has announced the topline results from its Phase 2 clinical trial evaluating SCD-044, a novel orally bioavailable sphingosine-1-phosphate (S1P) receptor 1 agonist, in patients with moderate to severe plaque psoriasis. The company confirmed that the trial did not meet its primary efficacy endpoint.

 

The Phase 2 study was a randomized, double-blind, placebo-controlled trial involving approximately 240 subjects. Its primary objective was to assess the efficacy and safety of SCD-044 as a potential oral treatment for plaque psoriasis, a chronic autoimmune skin disease. Despite the promising mechanism of action—targeting lymphocyte migration to reduce inflammation—the results did not demonstrate a statistically significant improvement over placebo in the primary efficacy measure.

 

SCD-044 had previously shown favorable safety and pharmacodynamic effects in Phase 1 studies, including consistent lymphocyte count reduction, which is considered a surrogate marker for efficacy in S1P receptor 1 agonists. The compound is still being evaluated for other autoimmune indications, such as atopic dermatitis, with additional Phase 2 data expected later this year.

 

Sun Pharma had entered into a global licensing agreement with Sun Pharma Advanced Research Company Ltd (SPARC) for the development and commercialization of SCD-044. The company remains committed to exploring the potential of SCD-044 in other indications and will review the full dataset to determine next steps for the program.

 

Source: Sun Pharmaceutical Industries Ltd