Verrica Announces Positive Preliminary Topline Results From Part 2 of Phase 2 Study of VP-315 for BCC

Basal cell carcinoma affecting the trunk | Image credit: DermNet

Verrica Pharmaceuticals recently announced new preliminary positive results from part 2 of its phase 2 clinical trial investigating VP-315 for the treatment of basal cell carcinoma (BCC). VP-35 is a potential first-in-class oncolytic peptide.¹

The 2-part phase 2 trial (NCT05188729) is an open-label, multicenter, dose-escalation, proof-of-concept study with a safety run-in designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of VP-315 when administered intratumorally to adults with biopsy-proven BCC. A total of 92 patients were enrolled in the trial with a histological diagnosis of BCC in at least one eligible target lesion.

“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 Jonathan Kantor, MD, a dermatologist and Mohs surgeon at Florida Center for Dermatology, the leading enrollment site for the study, in the news release. “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 preliminary results of part 2 are based on 93 confirmed BCC lesions that were treated during part 2. According to the announcement, regarding histologic reduction in tumor size and overall reduction in tumor size, data from 3 of the 93 lesions are pending.

Important preliminary results from part 2 include:

• 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 patients 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 patients (those with no residual tumor and those with residual tumor) of 86% (n=90)

“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. 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,” said Ted White, president and chief executive officer of Verrica, in the news release.

Verrica stated that it expects genomic and T-cell data in the first quarter of 2025 and will request an End-of-Phase 2 meeting with the US Food and Drug Administration (FDA) to evaluate the upcoming development of VP-315.

Verrica’s VP-102 (Ycanth) was approved for the treatment of molluscum contagiosum in July 2023 as the first FDA-approved treatment for the condition. VP-102 is a drug-device combination that contains a GMP–controlled formulation of cantharidin 0.7% w/v and gentian, a surgical dye meant to clearly mark treated lesions.²

References

1. Verrica Pharmaceuticals announces positive preliminary topline results from part 2 of phase 2 clinical study of VP 315 an investigational oncolytic peptide based immunotherapy for the treatment of patients with basal cell carcinoma. News release. Verrica Pharmaceuticals. August 14, 2024. Accessed August 14, 2024. https://verrica.com/press_release/verrica-pharmaceuticals-announces-positive-preliminary-topline-results-from-part-2-of-phase-2-clinical-study-of-vp-315-an-investigational-oncolytic-peptide-based-immunotherapy-for-the-treatment-of-pat/
2. Verrica Pharmaceuticals announces FDA approval of Ycanth (cantharidin) topical solution as the first FDA approved treatment of pediatric and adult patients with molluscum contagiosum. News release. Verrica Pharmaceuticals. July 21, 2023. Accessed August 14, 2024. https://verrica.com/press_release/verrica-pharmaceuticals-announces-fda-approval-of-ycanth-cantharidin-topical-solution-0-7/