Verrica's Skin Cancer Treatment VP-315 Shows 51% Tumor Clearance in Early Trial

Author: Benzinga Newsdesk | August 14, 2024 07:32am

Verrica Pharmaceuticals Inc. ("Verrica" or "the Company") (NASDAQ:VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced preliminary positive results from Part 2 of its Phase 2 clinical trial studying VP-315, a potential first-in-class oncolytic peptide, for the treatment of basal cell carcinoma.

"We believe the positive results from Part 2 of the Phase 2 study for VP-315 are a meaningful step forward in potentially providing basal cell carcinoma patients with additional treatment options," said Ted White, President and Chief Executive Officer of Verrica. "We are encouraged by our preliminary results, which we believe support the use of VP-315 as a first line therapy for use in both a primary and neoadjuvant setting. We believe VP-315 has the potential to be a multi-billion dollar commercial opportunity for Verrica."  

"Basal cell carcinoma is the most common form of cancer in the U.S. and current therapies have drawbacks, including systemic side-effects," said Dr. Gary Goldenberg, Verrica's Chief Medical Officer. "The preliminary results from Part 2 of the trial show greater than 50% complete histological clearance and a significant reduction in tumor size for tumors treated in the study, which we believe has the potential to vastly improve patient outcomes versus current therapies and surgical procedures. In addition, given the immunomodulatory properties of VP-315, we are also excited to continue to explore these properties in tissue and blood samples."

"VP315 has the potential to change the way dermatologists treat basal cell skin cancer. Patients may be cured with simple injections of VP-315," said Dr. Jonathan Kantor, a dermatologist and Mohs surgeon at Florida Center for Dermatology, which was the leading enrollment site for the clinical study. "Those patients that have residual tumor, can have surgery and decrease their surgical scar by more than 70%. It's very, very exciting data."

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 with a histological diagnosis of basal cell carcinoma in at least one eligible target lesion. For additional information about this clinical trial, please visit clinicaltrials.gov, identifier NCT05188729.

Part 2 preliminary results are based on 93 confirmed basal cell carcinoma lesions that were treated during Part 2 of the Phase 2 trial; 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 reduction of tumor size in those subjects with remaining tumor 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 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.

Posted In: VRCA