Verrica Pharmaceuticals Announces Last Patient Dosed in Part 2 of Phase 2 Study of VP-315, a Potential First-in-Class Oncolytic Peptide-Based Immunotherapy, for the Treatment of Basal Cell Carcinoma
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The advancement in treatments for basal cell carcinoma (BCC) is a critical area in oncology, given the high incidence rate of this skin cancer. The development of VP-315 as a potential first-in-class oncolytic peptide is noteworthy because it represents a novel therapeutic approach that diverges from traditional surgical methods. Oncolytic peptides are a form of biological therapy that harnesses the body's immune system to target and destroy cancer cells, potentially offering a less invasive option with fewer side effects such as pain, infection and scarring that are associated with surgical interventions.
From a clinical standpoint, the progress of VP-315 into the latter stages of Phase 2 trials is significant. It suggests that the treatment has shown sufficient safety and efficacy in earlier trials to warrant continued investigation. If the forthcoming lesion clearance data demonstrate positive outcomes, it could lead to a shift in the standard of care for BCC, improving patient quality of life and potentially reducing healthcare costs associated with surgical treatments.
The enrollment completion and last patient dosing in Verrica's Phase 2 trial of VP-315 is a pivotal milestone for the company's pipeline, which investors closely monitor. The focus on lesion clearance data as a key endpoint is particularly relevant, as it directly measures the treatment's efficacy in clearing cancerous cells. For stakeholders, the implications of successful trial results are multifaceted: it could enhance the company's valuation, attract partnership opportunities and pave the way for Phase 3 trials. However, it is essential to recognize that clinical trials are inherently risky and positive Phase 2 results do not guarantee success in subsequent phases or regulatory approval.
Given the high prevalence of BCC, a successful treatment could meet a substantial market demand. It is crucial to analyze the competitive landscape, as any new therapy would need to demonstrate superiority or complementary benefits to existing treatments. Moreover, the adoption of new treatments by healthcare providers hinges on factors such as cost-effectiveness, reimbursement policies and clinical guidelines, which will be shaped by the detailed outcomes of the trial.
The dermatology therapeutics market is an area of keen interest for investors due to the high prevalence of skin conditions and the constant demand for innovative treatments. Verrica's progress in developing VP-315 could capture a significant share of the BCC treatment market if the Phase 2 results are favorable. The anticipation of lesion clearance data from the trial is likely to influence Verrica's stock volatility as the market responds to potential indicators of the drug's future success or failure.
Long-term market potential for VP-315 hinges on several factors, including the final clinical trial results, regulatory hurdles, pricing strategy and market penetration rates. If VP-315 is approved, Verrica could potentially disrupt the BCC treatment paradigm, which is currently dominated by surgical procedures. The introduction of a non-surgical option could lead to market expansion by addressing patients who are unable or unwilling to undergo surgery. The company's strategic positioning and ability to execute a successful go-to-market plan will be critical in realizing the drug's commercial potential.
There are approximately 3-4 million diagnoses of basal cell carcinomas in the U.S. each year, with a high unmet need for new treatment options
Company reiterates lesion clearance data from Part 2 of Phase 2 expected in Q2 2024
WEST CHESTER, Pa., Jan. 05, 2024 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that the last patient has been dosed in Part 2 of the Company’s Phase 2 trial of VP-315, a potential first-in-class oncolytic peptide, for the treatment of basal cell carcinoma.
“We are pleased to announce that Part 2 of our Phase 2 clinical trial of VP-315 for the treatment of basal cell carcinoma has been fully enrolled and the last patient has been dosed,” said Ted White, Verrica’s President and Chief Executive Officer. “Basal cell carcinoma is the most common form of skin cancer in the U.S. each year and patients are in need of alternative solutions to surgery which can cause pain, infection and scarring. Verrica’s VP-315 program is designed to provide for the targeted delivery of an oncolytic peptide engineered to stimulate the patient’s immune system and destroy cancer cells. Our study remains on track, and we look forward to sharing the data from our Phase 2 clinical trial later this year.”
About the Phase 2 Trial of VP-315
The Phase 2 trial is a 2-part, open-label, multicenter, dose-escalation, proof-of-concept study with a safety run-in designed to assess the safety, pharmacokinetics, and efficacy of VP-315 when administered intratumorally to adults with biopsy-proven basal cell carcinoma. The study is expected to enroll approximately 80 adult subjects with a histological diagnosis of basal cell carcinoma in at least one eligible target lesion. For additional information about this clinical trial, please visit clinicaltrials.gov, identifier NCT05188729.
About VP- 315
VP-315 is a potential first-in-class oncolytic peptide immunotherapy administered directly into a tumor to induce immunogenic cell death, which may offer a non-surgical option for patients suffering from skin cancer. 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. Verrica has an exclusive worldwide license to develop and commercialize VP-315 for dermatologic oncology indications, including non-metastatic melanoma and non-metastatic merkel cell carcinoma, and intends to focus initially on basal cell and squamous cell carcinomas as the lead indications for development. VP-315 has demonstrated positive tumor-specific immune cell responses in multi-indication Phase 1/2 oncology trials. The timing of any future clinical trials of VP-315, if any, will be determined after the conclusion of the current Phase 2 trial for basal cell carcinoma.
About Basal Cell Carcinoma
Basal cell carcinoma is the most common form of cancer in the U.S., and incidence is rising worldwide. There are approximately 3-4 million diagnoses of basal cell carcinomas in the U.S. each year, with a high unmet need for new treatment options. Basal cell carcinoma is generally treated with invasive surgery to remove the tumor, which can cause pain, infection, bleeding and scarring.
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 benefits of VP-315, including the results of the Phase 2 clinical trial, the expansion of the VP-315 program into squamous cell carcinoma, the potential of VP-315 to be first-in-class, and the initiation of any future trials or clinical programs for VP-315, including a Phase 3 trial. 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
FAQ
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