Verrica Pharmaceuticals' VP-315 Basal Cell Carcinoma Results Accepted for 2024 Fall Dermatology Conference

Verrica Pharmaceuticals Inc., a company dedicated to developing dermatology therapeutics, recently announced the acceptance of two abstracts for presentation at the Fall Clinical Dermatology Conference in Las Vegas, Nevada. These abstracts will be showcased as posters highlighting data from Part 2 of the Company’s Phase 2 study on VP-315, a novel oncolytic peptide developed for the treatment of basal cell carcinoma (BCC).

The presented posters are titled “Results of a Phase 2 Multicenter Study Evaluating the Safety and Tolerability of VP-315, an Investigational therapy for Basal Cell Carcinoma” and “Results of a Phase 2 Multicenter Study to Evaluate the Efficacy of VP-315, an Investigational therapy for Basal Cell Carcinoma.” The clinical data comes from 82 patients with up to two target BCC tumors, summing up to a total of 92 tumors. These patients had tumors located on the head and neck areas. The goal of Part 2 of this Phase 2 trial was to explore and refine dosing regimens to identify an optimal approach for further Phase 3 studies.

In this study phase, approximately 51% of the treated tumors achieved complete histological clearance, indicating a significant reduction in tumor size. For patients with residual tumors, an average of 71% tumor size reduction was observed. No serious adverse events related to the treatment were reported, and most adverse events were categorized as mild to moderate.

Verrica Pharmaceuticals anticipates receiving genomic and T-cell response data in the first quarter of 2025. The company plans to request an End-of-Phase 2 meeting with the FDA in the first half of 2025 to discuss the subsequent steps for the development of VP-315 for BCC treatment.

Ted White, the President and CEO of Verrica, expressed optimism about the preliminary results of VP-315, suggesting that it could potentially provide new treatment options for BCC patients. According to White, the results support the use of VP-315 as a first-line therapy in both primary and neoadjuvant settings. As a novel oncolytic peptide that is directly administered into tumors, VP-315 offers a potential non-surgical alternative for the millions of BCC cases diagnosed annually in the U.S., representing a substantial commercial opportunity for Verrica.

In terms of the Phase 2 trial details, it is an open-label, multicenter, dose-escalation study with a safety run-in phase. This design aims to evaluate the safety, pharmacokinetics, and efficacy of VP-315 for adults with biopsy-confirmed BCC. The trial enrolled 92 adult subjects who had at least one eligible target lesion.

VP-315, an oncolytic chemotherapeutic peptide immunotherapy, is administered directly into tumors to induce immunogenic cell death, thereby triggering a broad immune response against tumor antigens. This approach could offer a non-surgical treatment option for patients with skin cancer. Developed from pioneering research in host defense peptides, VP-315 is under exclusive worldwide license by Verrica for dermatologic oncology indications, including non-metastatic melanoma and non-metastatic Merkel cell carcinoma. The initial focus is on basal cell and squamous cell carcinomas.

Basal cell carcinoma is the most frequently diagnosed cancer in the U.S., with a growing global incidence. Annually, 3-4 million new cases are reported in the U.S., highlighting the need for new treatment options. Currently, BCC is primarily treated through invasive surgeries, which can lead to complications such as pain, infection, bleeding, and scarring.

Verrica Pharmaceuticals is a dermatology therapeutics company working on treatments for skin diseases that require medical intervention. Their product YCANTH® (VP-102), a cantharidin-based treatment, is FDA-approved for treating molluscum contagiosum, a contagious viral skin infection affecting millions in the U.S., especially children. YCANTH® is also being developed for common and external genital warts. Additionally, Verrica is developing VP-103, another cantharidin-based product, for plantar warts. Through a worldwide license agreement with Lytix Biopharma AS, Verrica is advancing the development and commercialization of VP-315 for non-melanoma skin cancers, including basal cell and squamous cell carcinomas.