WEST CHESTER, PA — Verrica Pharmaceuticals Inc. (Nasdaq: VRCA) announced this week that Part 2 of its Phase 2 clinical trial for VP-315, a potential first-in-class oncolytic peptide, has yielded promising preliminary results for the treatment of basal cell carcinoma (BCC). The trial, which involved 93 confirmed lesions, demonstrated significant tumor size reduction and high rates of complete histological clearance.
VP-315 was shown to be well tolerated, with no serious treatment-related adverse events reported. All patients experienced a reduction in tumor size, with an overall reduction of approximately 86%. Furthermore, 51% of the lesions treated achieved complete histological clearance, meaning no residual tumor cells were detected. For patients with residual tumors, the average reduction in tumor size was around 71%.
Basal cell carcinoma is the most common form of cancer in the United States, with about 3.6 million cases diagnosed annually. This number is expected to rise due to an aging population, improved diagnostic methods, and increased exposure to risk factors.
“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.”
Current treatments for BCC often come with systemic side effects. Dr. Gary Goldenberg, Verrica’s Chief Medical Officer, highlighted the potential impact of VP-315 on patient outcomes. “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,” he said.
Dr. Jonathan Kantor, a dermatologist and Mohs surgeon at the Florida Center for Dermatology, which was the leading enrollment site for the clinical study, expressed optimism about VP-315’s potential to transform BCC treatment. “VP-315 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. Kantor. “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 designed to assess the safety, tolerability, pharmacokinetics, and efficacy of VP-315 when administered intratumorally to adults with biopsy-proven BCC. The study enrolled 92 adult subjects with at least one eligible target lesion.
Looking ahead, Verrica plans to request an End-of-Phase 2 meeting with the FDA in early 2025 to determine the next steps for VP-315’s development. The company expects to present the final Phase 2 data at future medical meetings and is committed to advancing new treatment options for BCC patients.
The encouraging findings from this trial spotlight VP-315’s potential as a groundbreaking therapy for basal cell carcinoma, offering hope for improved patient outcomes and a new approach to treating this common form of cancer.
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