First Dosing of Patient in Phase 2 Study Evaluating VP-315 for BCC

Verrica Pharmaceuticals recently announced that the first patient has been dosed in its part 2 of a phase 2 study (NCT05188729) evaluating VP-315, a potentially first-in-class oncolytic peptide, for the treatment of basal cell carcinoma (BCC).¹ Part 2 of the study is designed to investigate dosing regimens to determine the recommended dose for part 3 of the study, expected to begin in the first half of 2024.

The phase 2 trial is a 3-part, open-label, multicenter, dose-escalation, proof-of-concept study with a run-in designed to evaluate the safety, pharmacokinetics, and efficacy of VP-315 administered intratumorally to adults with biopsy-proven BCC. Approximately 66 total adult patients will be enrolled in the trial who have a histological diagnosis of BCC in at least one eligible target lesion.

VP-315 is an oncolytic peptide immunotherapy administered directly into a patient’s tumor to induce immunogenic cell death, creating a potential non-surgical option for patients. According to Verrica, “The technology is based on pioneering research in ‘host defense peptides’ – nature’s first line of defense towards foreign pathogens. VP-315 is a chemotherapeutic administered intratumorally and works by inducing lysis of intracellular organelles of tumor cells such as mitochondria, thereby unleashing a broad spectrum of tumor antigens for T cell responses.” Additionally, VP-315 has shown positive tumor-specific immune cell responses in multi-indication phase ½ oncology trials.

Verrica has recently been discussed in dermatology news for the development of a 2nd novel drug, VP-102 for the treatment of molluscum contagiosum. In February of this year, the US Food and Drug Administration (FDA) accepted Verrica’s resubmitted New Drug Application for VP-102. The FDA assigned VP-102 a Prescription Drug User Fee Act date of July 23, 2023. Verrica’s VP-102 has the potential to become the first FDA-approved treatment for molluscum contagiosum.

Additionally, the third drug Verrica is in the process of developing is VP-103, a second cantharidin-based drug-device for the treatment of plantar warts caused by the human papilloma virus. Verrica has not yet begun phase 2 trials of VP-103.

Reference

1. Verrica Pharmaceuticals announces dosing of the first patient in part 2 of phase 2 study evaluating VP-315 for the treament of basal cell carcinoma. Verrica Pharmaceuticals. Published April 12, 2023. Accessed April 12, 2023.https://www.biospace.com/article/releases/verrica-pharmaceuticals-announces-dosing-of-the-first-patient-in-part-2-of-phase-2-study-evaluating-vp-315-for-the-treatment-of-basal-cell-carcinoma/