Verrica Pharma Reveals Positive Early Results from Phase 2 Study of VP-315 for Basal Cell Carcinoma

Verrica Pharmaceuticals Inc., a dermatology therapeutics company, has announced promising preliminary results from Part 2 of its Phase 2 clinical trial for VP-315, an innovative oncolytic peptide intended to treat basal cell carcinoma. Basal cell carcinoma is the most prevalent cancer in the U.S., with around 3.6 million cases diagnosed annually, a number expected to increase due to factors such as an aging population and enhanced diagnostic methods.

VP-315 demonstrated significant efficacy and safety in the clinical trial, showing no treatment-related serious adverse events. All patients treated exhibited tumor size reduction. Impressively, there was an 86% overall reduction in tumor size across all lesions treated in Part 2. Additionally, 51% of lesions achieved complete histological clearance, indicating no remaining tumor cells. For patients with residual tumors, an average of 71% tumor size reduction was achieved.

Ted White, President, and CEO of Verrica, expressed optimism about the results, suggesting that VP-315 could potentially serve as a first-line therapy for basal cell carcinoma, both for primary treatment and as a neoadjuvant therapy. He also highlighted the substantial commercial potential of VP-315, envisioning it as a multi-billion dollar opportunity.

Dr. Gary Goldenberg, Verrica’s Chief Medical Officer, emphasized the drawbacks of current basal cell carcinoma treatments, such as systemic side effects. He noted that VP-315's ability to induce significant tumor size reduction and complete histological clearance could greatly improve patient outcomes compared to existing therapies and surgical procedures. The immunomodulatory properties of VP-315 are also a subject of interest for further exploration.

Dr. Jonathan Kantor, a dermatologist and Mohs surgeon at the Florida Center for Dermatology, shared his enthusiasm over the clinical data, suggesting that VP-315 could revolutionize dermatological treatment for basal cell carcinoma. He pointed out that patients could potentially avoid extensive surgery, thus minimizing surgical scars by more than 70%.

The Phase 2 trial is a comprehensive 2-part, open-label, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of VP-315 when administered intratumorally. The study enrolled 92 adult subjects diagnosed with basal cell carcinoma, involving 93 lesions in Part 2. Although data from three lesions are still pending, the preliminary results are encouraging.

The company plans to release genomic and T-cell response data by the first quarter of 2025. Furthermore, Verrica intends 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 basal cell carcinoma. The final Phase 2 data is also set to be presented at upcoming medical conferences.

VP-315, based on research into "host defense peptides," is an oncolytic peptide immunotherapy administered directly into tumors. This approach induces immunogenic cell death and could provide a non-surgical treatment option for skin cancer patients. The technology triggers the destruction of tumor cell organelles, releasing tumor antigens that prompt T cell responses.

Verrica Pharmaceuticals aims to develop and commercialize VP-315 for various non-melanoma skin cancers, including basal cell carcinoma and squamous cell carcinoma. The company has demonstrated positive immune cell responses in earlier phase oncology trials and will determine future clinical trials based on the current Phase 2 trial's conclusion.