CHENNAI: Shares of India's largest drug maker Sun Pharmaceutical Industries fell almost 1% on main stock exchanges on Wednesday following the company's announcement of a disappointing trial results of its much expected novel drug for psoriasis.
The company said in a statement on Tuesday that it is discontinuing further development of its investigational drug SCD-044, a novel orally bioavailable anti-psoriasis drug following disappointing Phase 2 trial results. This investigational drug was tested for both psoriasis and atopic dermatitis indications.
The company said that the trials (double-blind, placebo-controlled Phase 2 trial evaluated the efficacy and safety) were conducted in 263 patients with moderate to severe plaque psoriasis. The primary endpoint was the proportion of patients achieving a 75% reduction in the psoriasis area. The trial failed to meet this endpoint, although no major safety or tolerability issues were reported.
“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 Dr. Marek Honczarenko, Senior Vice President and Head of Global Specialty Development at Sun Pharma.
There was a parallel phase 2 study conducted for this drug candidate for atopic dermatitis or eczema, an auto immune condition affecting the skin. These trials were also discontinued after the results were found unsatisfactory.
In this study, some 250 patients with moderate to severe atopic dermatitis were tested. These trials were also failed to meet its primary efficacy goal of a 75% improvement in eczema area.
A prior Phase 1 study on this drug in healthy volunteers had demonstrated favorable safety and pharmacodynamic activity. Despite these promising early signals, the Phase 2 failures indicate limited clinical benefit in the targeted dermatological indications.
Sun Pharma and its partner, Sun Pharma Advanced Research Company Ltd. (SPARC), will assess next steps regarding the SCD-044 asset, though no further trials are planned at this time.
The decision to halt development of this drug is a major setback for the Mumbai-based drug maker as it bets big on novel or specialty medicines, focusing on delivering high-impact therapies across its global specialty portfolio.