JAMA Dermatology Publishes Results from Verrica’s Two Pivotal Phase III CAMP (Cantharidin Application in Molluscum Patients) Trials

Rhea-AI Summary

Verrica Pharmaceuticals (Nasdaq: VRCA) announced the publication of positive results from its pivotal Phase III CAMP studies on VP-102 for treating molluscum contagiosum in the Journal of the American Medical Association (JAMA) Dermatology. The studies, involving over 500 participants, indicated that 46% in CAMP-1 and 54% in CAMP-2 achieved complete clearance of lesions with VP-102, compared to 18% and 13% respectively for the vehicle group (p<0.001). VP-102 was well tolerated, with no serious adverse events reported. The results may enhance the prospects of VP-102 as a safe FDA-approved treatment for a viral skin infection.

Positive

• Publication of positive Phase III study results in a reputable journal enhances credibility.
• VP-102 demonstrated significant efficacy, achieving up to 54% lesion clearance compared to 13% in controls.
• The trials included over 500 participants, showcasing a substantial sample size for efficacy data.
• No serious adverse events were reported, indicating a favorable safety profile.

Negative

• The FDA issued a Complete Response Letter for the NDA for VP-102 in July 2020, indicating unresolved issues.
• Regulatory approval remains uncertain and may be impacted by risks inherent in the drug development process.

WEST CHESTER, Pa., Sept. 23, 2020 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that positive results from the two pivotal Phase III CAMP (Cantharidin Application in Molluscum Patients [CAMP-1 and CAMP-2]) studies evaluating the safety and efficacy of VP-102 in children and adults with molluscum were published in the Journal of the American Medical Association (JAMA) Dermatology.

The CAMP studies evaluated a topical application of VP-102, a propriety drug-device combination containing cantharidin 0.7% (w/v) in a shelf-stable formulation, in over 500 children and adults with molluscum at 31 treatment sites. Treatment with VP-102 demonstrated superior results compared to vehicle in the percentage of participants with complete clearance of molluscum lesions at the end of the trial (day 84). In CAMP-1, 46% of participants treated with VP-102 achieved complete clearance of molluscum lesions compared to 18% of participants in the vehicle group (p<0.001); in CAMP-2, 54% of participants treated with VP-102 achieved complete clearance of molluscum lesions compared to 13% of participants in the vehicle group (p<0.001). VP-102 was well-tolerated in both trials, with no serious adverse events reported in VP-102 treated subjects. The results were previously presented at the 2019 American Academy of Dermatology (AAD) annual meeting in a late-breaking oral presentation.

“Publication in JAMA Dermatology is a significant achievement for our company and highlights the robust body of data supporting the potential of VP-102 as a safe and effective topical therapy for molluscum, a viral skin infection for which there are no FDA-approved treatments,” commented Ted White, Verrica President and CEO. “We are proud to advance the field of medical dermatology by completing the first large-scale, randomized controlled trials evaluating cantharidin with a consistent formulation, dosing schedule, and method of application for the treatment of molluscum. Compounded cantharidin is associated with the treatment of molluscum, but patients and physicians do not currently have access to a proven safe and standardized formulation. VP-102 has the potential to be the first product in commercial development to enable consistent and safe application of topical cantharidin. We look forward to potentially bringing VP-102 therapy to the millions of molluscum patients, primarily children, who are in need of a safe and effective FDA-approved treatment.”

The published article, “Safety and Efficacy of VP-102, a Proprietary, Drug-Device Combination Product Containing Cantharidin, 0.7% (w/v), in Children and Adults with Molluscum Contagiosum,” can be accessed on the JAMA Dermatology website and the Publications section of the Verrica website at www.verrica.com.

About Verrica Pharmaceuticals Inc.

Verrica is a dermatology therapeutics company developing medications for 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. Verrica submitted an NDA for VP-102 for the treatment of molluscum in September 2019. A Complete Response Letter was received from the FDA regarding the NDA for VP-102 on July 13, 2020. If approved, VP-102 will be marketed in the United States under the conditionally accepted brand name YCANTH™. In addition, Verrica has successfully completed a Phase 2 study of VP-102 for the treatment of common warts and is currently conducting a Phase 2 study of VP-102 for the treatment of external genital warts. The Company is also developing VP-103, its second cantharidin-based product candidate, for the treatment of plantar warts. For more information, visit www.verrica.com.

Forward-Looking Statement

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 Company’s expectations with regard to its interactions and communications with the FDA, the potential approval of the NDA for VP-102 following resubmission, and the potential benefits and potential commercialization of VP-102 for the treatment of molluscum, if approved. 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, uncertainties related to the COVID-19 pandemic and other risks and uncertainties that are described in Verrica’s Annual Report on Form 10-K for the year ended December 31, 2019, Verrica’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, 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.

FAQ

What are the results of the Phase III CAMP studies for VRCA?

The Phase III CAMP studies demonstrated that 46% and 54% of participants treated with VP-102 achieved complete clearance of molluscum lesions compared to 18% and 13% for the vehicle group.

What is VP-102 and its significance for VRCA?

VP-102 is a proprietary drug-device combination intended for treating molluscum contagiosum, a viral skin infection with no FDA-approved treatments.

What is the current regulatory status of VP-102?

Verrica received a Complete Response Letter from the FDA regarding the NDA for VP-102 in July 2020, which indicates that the approval process has challenges.

When was the positive study published for VP-102 by Verrica Pharmaceuticals?

The positive results from the CAMP studies were published on September 23, 2020, in JAMA Dermatology.