Results from the second part of a phase 2 open-label, multicenter, dose-escalation, proof-of-concept study suggest that VP-315 from Verrica Pharmaceuticals may be effective for the treatment of basal cell carcinoma. VP-315 is a potential first-in-class oncolytic peptide injected into tumors.
Preliminary results are based on 93 confirmed basal cell carcinoma lesions that were treated during Part 2 of the Phase 2 trial; however, data are pending from three of the 93 lesions for histologic reduction in tumor size and overall reduction in tumor size.
Treatment resulted in complete histologic clearance in half (51%) of lesions. Histological reduction of tumor size in those subjects with remaining tumor was 71%. 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).
No dose-limiting toxicities were identified, and no Treatment-Related Serious Adverse Events (TSAEs) were reported. Most TSAEs were expected mild to moderate cutaneous reactions (n=93).
The phase 2 trial was designed with a safety run-in intended 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 with a histological diagnosis of basal cell carcinoma in at least one eligible target lesion.
Verrica says it 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 to determine next steps for the development of VP-315 for the treatment of BCC in the first half of 2025. The Company also plans to submit the final Phase 2 data for presentation at future medical meetings.
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