– Analysis suggested statistically significantly higher lesion clearance with VP-102 compared to vehicle in all regions of the body, including those deemed most sensitive –
– If approved, VP-102 will be marketed in the United States as YCANTH™ (cantharidin 0.7% Topical Solution), and would be the first FDA-approved treatment for molluscum –
WEST CHESTER, Pa., Jan. 18, 2020 (GLOBE NEWSWIRE) — Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for viral skin diseases requiring medical interventions, today announced the presentation of positive data from a post-hoc pooled analysis of the pivotal Phase 3 CAMP trials evaluating the safety and efficacy of VP-102 (cantharidin 0.7% topical solution), Verrica’s lead product candidate for the treatment of molluscum contagiosum (molluscum). The new analysis showed that the percentage of patients with complete clearance of all lesions was statistically significantly higher in the VP-102 group than vehicle, across all body regions. Results from this analysis are being presented in a poster on January 18th-22nd at the 17th Annual Winter Clinical Dermatology Conference in Kohala Coast, Hawaii.
“The results of this study are important, as they suggest that this investigational molluscum treatment can potentially bring about complete clearance, regardless of where on the body the lesion is located,” said Lawrence Eichenfield, MD, Chief of Pediatric and Adolescent Dermatology, Rady Children’s Hospital, San Diego, CA, and principal investigator of the VP-102 Phase 3 molluscum program. “If approved, VP-102 may potentially be an important option for physicians, as they can have the option to treat even the most sensitive areas, including the groin, head, and neck.”
In this analysis of the CAMP studies, the intent-to-treat (ITT) patient population had molluscum lesions in specific areas at baseline, including: head/neck (n=77 VP-102, n=53 vehicle); chest/abdomen (n=142, 118); back/buttocks (n=117, 91); groin (n=28, 25); upper extremities (n=179, 131); and lower extremities (n=186, 141). Efficacy was measured by the percentage of subjects with complete clearance of lesions in each location by visit. Data demonstrated a statistically significantly greater percentage of complete lesion clearance by the end of the study (Day 84) across all body regions analyzed among patients receiving VP-102, as compared to vehicle. Specific results showed:
In the study, VP-102 safety results demonstrated similar adverse event rates across all body regions. Incidence of application site Treatment Emergent Adverse Events (TEAEs) were evaluated based on the pre-specified subset of application site reactions reported during or after Treatment Visit 1 and before Visit 2. The most common TEAEs included application site vesicles, pain, pruritus, scab, erythema, dryness, discoloration, and edema.
About Verrica Pharmaceuticals Inc.
Verrica is a dermatology therapeutics company developing medications for viral skin diseases requiring medical interventions. The Company’s late-stage product candidate, VP-102, is a potential first-in-class topical therapy for the treatment of molluscum contagiosum and common warts. Molluscum is a highly contagious viral skin infection affecting approximately six million people, primarily children, in the United States, and common warts are contagious skin growths affecting 22 million people. There are currently no FDA-approved treatments for molluscum or common warts. Following positive topline results from two pivotal Phase 3 trials, the Company submitted an NDA on September 13, 2019 for VP-102 for the treatment of molluscum; on November 26, 2019, the Company received notice that the FDA accepted the NDA for filing, with a Prescription Drug User Fee Act (PDUFA) goal date of July 13, 2020. If approved, VP-102 will be marketed in the United States under the conditionally accepted brand name YCANTH™. Verrica intends to commence a Phase 3 program in the first quarter of 2020 to evaluate VP-102 for common warts. VP-102 is also currently in a Phase 2 trial for the treatment of external genital warts. A second product candidate, VP-103, is in pre-clinical development for plantar warts. For more information, visit www.verrica.com.
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Verrica’s current beliefs and expectations. These forward-looking statements include expectations regarding the potential benefits and potential approval of VP-102 for the treatment of molluscum and the clinical development of VP-102 for additional indications, including common warts, external genital warts and plantar warts. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the drug development process and the regulatory approval process, Verrica’s reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Verrica’s Annual Report on Form 10-K for the year ended December 31, 2018, filed with the U.S. Securities and Exchange Commission on March 7, 2019, and other filings Verrica makes with the U.S. Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and are based on information available to Verrica as of the date of this release, and Verrica assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.