Sun Pharma Discontinues Psoriasis and Eczema Drug SCD-044 After Phase 2 Trial Failures
核心洞察
Sun Pharma's experimental oral drug SCD-044 (Vibozilimod) failed to meet primary endpoints in Phase 2 trials for both psoriasis (搜索) and atopic dermatitis (搜索), missing the 75% improvement target in PASI and EASI scores at 16 weeks.
The company has discontinued further clinical development of SCD-044, which was considered one of the more promising assets in SPARC's specialty pipeline for inflammatory disorders.
SPARC shares plunged 19% following the disappointing results, while Sun Pharma and its R&D arm will reassess the compound's future despite the drug being generally safe and well tolerated.
Sun Pharmaceutical Industries announced the discontinuation of its experimental drug SCD-044 (Vibozilimod) after the oral treatment failed to meet primary endpoints in two Phase 2 clinical trials for psoriasis (搜索) and atopic dermatitis (搜索). The disappointing results led to a 19% crash in shares of Sun Pharma Advanced Research Company (SPARC), the research arm of India's largest drugmaker.
Trial Results Fall Short of Expectations
The psoriasis (搜索) trial, involving 263 patients, failed to achieve the primary endpoint of a 75% improvement in symptoms as measured by the Psoriasis Area and Severity Index (PASI) at the 16-week mark. PASI is a widely used scoring system that combines the extent and severity of psoriasis to assess treatment response.
Similarly, a separate trial in 250 patients with atopic dermatitis (搜索), commonly known as eczema (搜索), also missed its primary benchmark. The study failed to demonstrate a 75% reduction in symptoms using the Eczema Area and Severity Index (EASI) at Week 16.
Both studies were part of the SOLARES clinical program, with the psoriasis (搜索) study designated as SOLARES PsO and the atopic dermatitis (搜索) study as SOLARES AD.
Safety Profile Remains Favorable
Despite the efficacy failures, Sun Pharma reported that SCD-044 was generally safe and well tolerated across both patient populations. However, the lack of therapeutic benefit at the primary endpoint led the company to halt further clinical development of the compound.
"We are disappointed with the results and thank all patients and healthcare professionals who participated in the studies," said Marek Honczarenko, Senior Vice President, Global Specialty Development at Sun Pharma.
Market Impact and Strategic Implications
The trial failures represent a significant setback for SPARC, as SCD-044 was considered one of the more promising assets in the company's specialty pipeline focused on inflammatory disorders. SPARC shares plunged to Rs 158 apiece, reflecting investor disappointment over the lost potential of the investigational treatment.
Sun Pharma's main shares closed at ₹1,667.65 on the BSE, down 0.43% following the announcement. Both Sun Pharma and SPARC indicated they will reassess the future of the compound and evaluate next steps.
Financial Context
For the fourth quarter of FY25, SPARC reported total income of Rs 20.96 crore, representing a 38.8% quarter-on-quarter increase from Rs 15.10 crore in Q3FY25. However, the company's loss before tax widened to Rs 105.41 crore from Rs 79.44 crore in the previous quarter, reflecting ongoing investment in research and development activities.
SPARC, as a research-driven biopharmaceutical subsidiary of Sun Pharma, maintains its focus on innovation across oncology, neurodegenerative diseases, and inflammatory disorders despite this clinical setback.