Verrica Pharmaceuticals Announces Receipt of Minutes from Type C Meeting with FDA Regarding Clinical Development of YCANTH™ for the Treatment of Common Warts
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The announcement from Verrica Pharmaceuticals regarding the successful outcome of their Type C meeting with the FDA for the development of YCANTH for treating common warts represents a strategic milestone for the company. This development is pivotal as it signifies regulatory progress and could potentially lead to an expanded market for YCANTH, which is currently approved for molluscum contagiosum. The potential label expansion into the common warts market, which affects over 20 million people in the U.S. annually, indicates a substantial growth opportunity for Verrica.
From an industry perspective, the absence of FDA-approved products for common warts underscores the significance of YCANTH's clinical advancement. The market opportunity for a new, effective treatment is sizable and Verrica's focus on addressing unmet needs in dermatology could translate into a competitive edge. However, it is essential to consider the risks associated with clinical development, including the possibility of unfavorable results in Phase 3 trials or further regulatory hurdles.
The progress of YCANTH into a pivotal Phase 3 study is noteworthy from a medical research standpoint. The drug's existing approval for molluscum contagiosum sets a precedent for its safety and efficacy profile in a related dermatological condition. This prior approval may provide a level of confidence in the drug's potential for treating common warts. However, the distinct pathophysiology of common warts compared to molluscum contagiosum necessitates rigorous Phase 3 testing to establish YCANTH's efficacy and safety in this new indication.
It's also important to understand the clinical and commercial implications of a successful label expansion. If YCANTH proves effective for common warts, it could become a standard of care, significantly impacting treatment paradigms. The drug's impact on patient quality of life and healthcare costs will be critical factors in its adoption and success in the market.
The financial implications of Verrica Pharmaceuticals' announcement are multifaceted. The potential label expansion for YCANTH into the treatment of common warts represents not only a new revenue stream but also a diversification of the company's product portfolio. Given the size of the target market, a successful Phase 3 trial and subsequent FDA approval could lead to a notable increase in the company's valuation.
Investors should closely monitor Verrica's progress through the Phase 3 development, as any updates will likely impact the company's stock performance. The capital requirements for a Phase 3 study and the timeline to market should also be considered, as these factors will influence the company's financial health and its ability to sustain operations until potential product launch.
WEST CHESTER, Pa., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica” or “the Company”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that it received the minutes from the Company’s recent Type C meeting with the U.S. Food and Drug Administration (FDA), which was held on November 6, 2023, to discuss the Phase 3 clinical development plan for YCANTH for the treatment of common warts. More specifically, the Company believes that the Type C meeting satisfied its objective to gain the FDA’s advice and agreement on the overall design of a pivotal Phase 3 study of YCANTH that would support an efficacy supplement for the proposed indication of common warts. YCANTH is currently only approved to treat molluscum contagiosum in adults and children two years of age and older.
“We believe our recent Type C meeting with the FDA was highly productive and led to mutual alignment with respect to the design of a Phase 3 development plan to evaluate YCANTH for the treatment of common warts,” said Ted White, President & Chief Executive Officer of Verrica Pharmaceuticals. “Based upon positive results from our Phase 2 studies, we consider YCANTH to have significant potential to address this sizable market opportunity which affects over 20 million people in the U.S. annually with no FDA approved products. We remain focused on addressing some of the largest unmet needs in dermatology, and the successful outcome of this Type C meeting is an important step forward as we evaluate label expansion opportunities for YCANTH.”
About YCANTH™ (formerly VP-102)
YCANTH™ is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin delivered via a single-use applicator that allows for precise topical dosing and targeted administration for the treatment of molluscum. YCANTH™ is currently approved by the FDA to treat molluscum — a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. Please visit YCANTHPro.com for additional information.
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.
YCANTH™ should only be administered by a trained healthcare professional. YCANTH™ is not for home use.
About Common Warts
Common warts (verruca vulgaris) are skin growths caused by a contagious viral skin infection, most commonly on the fingers or hands. The human papilloma virus (HPV), the causative agent in common warts, is transmitted by touch. The virus enters the skin and causes skin growths by inducing the skin cells to multiply rapidly. Common warts are benign, but treatment is recommended to prevent the spread of infection and relieve the patient’s physical and psychological discomfort.
About Verrica Pharmaceuticals Inc.
Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. On July 21, 2023, Verrica’s lead product, YCANTH (cantharidin), became the first treatment approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum, a highly contagious viral skin infection affecting approximately 6 million people in the United States, primarily children. VP-102 is also in development to treat common warts and external genital warts, two of the largest remaining unmet needs in medical dermatology since YCANTH’s approval. Verrica is developing VP-103, its second cantharidin-based product candidate, for the treatment of plantar warts. Verrica has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize VP-315 (formerly LTX-315 and VP-LTX-315) for non-melanoma skin cancers including basal cell carcinoma and squamous cell carcinoma. 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 the Company’s expectations with regard to the clinical development and potential FDA approval of and commercialization of VP-102 for the treatment of common warts in the United States. 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, 2022, Verrica’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, 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
tkohler@verrica.com
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com
Chris Calabrese
LifeSci Advisors
ccalabrese@lifesciadvisors.com
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