Verrica Pharmaceuticals Holds Type A Meeting with FDA for VP-102 for Molluscum Contagiosum

Rhea-AI Summary

Verrica Pharmaceuticals Inc. (Nasdaq: VRCA) held a Type A meeting with the FDA on June 27, 2022, to discuss the NDA resubmission for VP-102, aimed at treating molluscum contagiosum. The company expressed satisfaction with the FDA's collaborative approach regarding stability data and post-approval options. VP-102 could become the first FDA-approved treatment for this contagious skin disease affecting six million people, primarily children. In addition, VP-102 has completed Phase 2 studies for common and external genital warts, highlighting Verrica's commitment to dermatological needs.

Positive

• FDA meeting showed collaborative progress on VP-102 approval.
• Potential first FDA-approved treatment for molluscum contagiosum.
• Strong support from caregivers and the medical community.

Negative

• None.

WEST CHESTER, Pa., June 28, 2022 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (Verrica) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that the Company held a Type A meeting with the U.S. Food and Drug Administration (FDA) on June 27, 2022 regarding the path forward for the resubmission and potential approval of the New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum).

“We are pleased with our communications with the FDA leading up to and during yesterday’s Type A meeting,” said Ted White, Verrica’s President and Chief Executive Officer. “In particular, we are encouraged by the FDA’s willingness to work collaboratively with us on the amount of stability data required from an alternative contract manufacturing organization (CMO) for our bulk solution at the time of resubmission as well as our options for post-approval use of bulk solution previously manufactured. We remain confident in VP-102 as the potential first FDA-approved treatment option for molluscum, and we continue to be encouraged by the overwhelming support from caregivers and the medical community.”

About VP-102

Verrica’s lead product candidate, VP-102, is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin (0.7% w/v) delivered via a single-use applicator that allows for precise topical dosing and targeted administration. VP-102 could potentially be the first product approved by the FDA to treat molluscum contagiosum — a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. 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 a Phase 2 study of VP-102 for the treatment of external genital warts.

About Molluscum Contagiosum (Molluscum)

There are currently no FDA-approved treatments for molluscum, a highly contagious viral skin disease that affects approximately six million people — primarily children — in the United States. Molluscum is caused by a pox virus that produces distinctive raised, skin-toned-to-pink-colored lesions that can cause pain, inflammation, itching and bacterial infection. It is easily transmitted through direct skin-to-skin contact or through fomites (objects that carry the disease like toys, towels or wet surfaces) and can spread to other parts of the body or to other people, including siblings. The lesions can be found on most areas of the body and may carry substantial social stigma. Without treatment, molluscum can last for an average of 13 months, and in some cases, up to several years.

About Verrica Pharmaceuticals Inc.

Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. Verrica’s late-stage product candidate, VP-102, is in development to treat molluscum, common warts and external genital warts, three of the largest unmet needs in medical dermatology. Verrica is also developing VP-103, its second cantharidin-based product candidate, for the treatment of plantar warts. The Company has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize LTX-315 for dermatologic oncology conditions. For more information, visit www.verrica.com.

Forward-Looking Statements

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,” “look forward,” and similar expressions, and are based on Verrica’s current beliefs and expectations. These forward-looking statements include Verrica’s expectations with regard to interactions with the FDA, the potential resubmission of the NDA for VP-102 and the potential benefits 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, 2021 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.

FOR MORE INFORMATION, PLEASE CONTACT:

Investors:

Terry Kohler
Chief Financial Officer
info@verrica.com

William Windham
Solebury Trout
646.378.2946
wwindham@soleburytrout.com

Media:

Zara Lockshin
Solebury Trout
646.378.2960
zlockshin@soleburytrout.com 

FAQ

What was the purpose of the FDA Type A meeting held by Verrica Pharmaceuticals on June 27, 2022?

The FDA Type A meeting aimed to discuss the resubmission and potential approval of the New Drug Application (NDA) for VP-102, a treatment for molluscum contagiosum.

What is VP-102 and its significance in dermatology?

VP-102 is a proprietary drug-device combination product being developed as a potential first FDA-approved treatment for molluscum contagiosum, affecting about six million people in the U.S.

What has been the response of the FDA regarding VP-102's approval process?

The FDA showed willingness to collaborate on stability data requirements and the potential post-approval use of previously manufactured bulk solution.

How many people are affected by molluscum contagiosum in the U.S.?

Molluscum contagiosum affects approximately six million people in the United States, primarily children.

What were the outcomes of the Phase 2 studies conducted for VP-102?

Verrica successfully completed Phase 2 studies of VP-102 for treating common warts and external genital warts.