Verrica Pharmaceuticals Inc. (NASDAQ:VRCA) released preliminary results from Part 2 of its Phase 2 trial of VP-315 for basal cell carcinoma.
The Phase 2 trial is a 2-part, open-label, multicenter, dose-escalation, proof-of-concept study with a safety run-in designed to assess the safety and tolerability, pharmacokinetics, and efficacy of VP-315 when administered intratumorally to adults with biopsy-proven basal cell carcinoma.
The study enrolled 92 adult subjects. The Part 2 preliminary results are based on 93 confirmed basal cell carcinoma lesions treated during the Phase 2 trial’s Part 2.
However, for histologic reduction in tumor size and overall reduction in tumor size, data from three of the 93 lesions are pending.
The key preliminary Part 2 results were:
No dose-limiting toxicities or treatment-related serious adverse events were reported.
Most treatment-related adverse events were expected mild to moderate cutaneous reactions (n=93).
51% of lesions treated resulted in complete histologic clearance, with no residual tumor cells (n=93).
Histological tumor size reduction in those subjects with remaining tumors was 71% (n=90).
All patients treated with VP-315 had a reduction in tumor size with an overall reduction of tumor size in all subjects (those with no residual tumor and those with residual tumor) of 86% (n=90).
The company expects genomic and T-cell (immune response) data in the first quarter of 2025 and plans to request an End-of-Phase 2 meeting with the FDA in the first half of 2025 to determine the next steps for developing VP-315 for treating basal cell carcinoma.
As of June 30, 2024, Verrica had cash and cash equivalents of $31.9 million, expected to support planned operations into the first quarter of 2025.
https://finance.yahoo.com/news/why-dermatology-focused-verrica-pharmaceuticals-135210938.html
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