Verrica Pharmaceuticals Announces Presentation of Lesion Clearance Data from an Ongoing Phase 2 Study of VP-315 for the Treatment of Basal Cell Carcinoma at the American Academy of Dermatology (AAD) 2023 Innovation Academy Meeting

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Verrica Pharmaceuticals presented lesion clearance data from Part 1 of a Phase 2 study of VP-315 for the treatment of basal cell carcinoma (BCC). The study showed consistent clinical and histological clearance of treated BCC lesions with the 8 mg dose of VP-315, with 67% of subjects showing complete tumor clearance. The company plans to expand Part 2 of the trial based on these positive results.

Presentation highlights the antitumor response of VP-315 for the non-surgical treatment of Basal Cell Carcinoma (BCC) as determined by clinical and histological lesion clearance

There are approximately 3-4 million diagnoses of basal cell carcinomas in the U.S. each year, with a high unmet need for non-surgical treatment options

WEST CHESTER, Pa., Aug. 10, 2023 (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 the presentation of lesion clearance data from Part 1 of an ongoing Phase 2 study of VP-315 for the treatment of basal cell carcinoma (BCC). The presentation is titled “VP-315, an Investigational Non-surgical Immunotherapy in Subjects with Biopsy Proven Basal Cell Carcinoma” and highlights the antitumor response of VP-315 as determined by clinical and histological clearance of treated BCC lesions. Dr. Neal Bhatia MD, Director of Clinical Dermatology Therapeutics Clinical Research in San Diego and Principal Investigator for the study, presented the data at the 2023 American Academy of Dermatology Innovation Academy, which is being held from August 10-13^th, in Tampa, FL.

Part 1 Study Results

• Subjects received once daily dosing of VP-315, administered intratumorally, in up to 2 biopsy-proven BCC lesions for up to 6 treatments over a 2-week period.
• Six lesions were treated at the 8 mg dose and post-treatment clinical assessment and excisions were performed at Day 49 (Range 35-70), followed by histological evaluation.
• Consistent clinical and histological clearance of treated BCC lesions was observed by Day 49 post-treatment with the 8 mg dose of VP-315, with 4 of 6 subjects (67%) showing complete tumor clearance. The other 2 subjects showed a partial response in tumor burden reduction (95% tumor clearance and 30% tumor clearance).
• Optimization of the 8 mg dosing regimen is under investigation in Part 2 of the study.
• These early encouraging results from Part 1 support VP-315 as a potential non-surgical therapeutic approach for BCC.
  

“We are pleased to report these encouraging results for our novel oncolytic peptide therapy, VP-315, in basal cell carcinoma at this year’s American Academy of Dermatology Innovation Academy,” said Ted White, President and Chief Executive Officer of Verrica Pharmaceuticals. “Based on the stronger than expected activity we observed in patients receiving the 8 mg dose of VP-315, we recently made the decision to expand Part 2 of the ongoing Phase 2 trial which we believe will accelerate the clinical development of VP-315.”

“While surgery remains the most commonly used treatment for basal cell carcinoma, many patients are poor surgical candidates due to their general health or experience surgical fatigue and would welcome a non-surgical treatment approach,” said Dr. Gary Goldenberg, Chief Medical Officer of Verrica Pharmaceuticals. “The VP-315 program is designed to address these issues through targeted delivery of an oncolytic peptide specifically engineered to stimulate the patient’s own immune system and destroy cancer cells, while minimizing the impact on the surrounding healthy skin cells. The positive data presented at the 2023 AAD Innovation Academy meeting shows that VP-315 has been observed to induce biologic activity against tumor cells in basal cell carcinoma, demonstrating positive clinical and histologic clearance even at this early stage of development. We are excited to continue our investigation of this highly innovative and promising new treatment for basal cell carcinoma, and with the expansion of Part 2, we have increased the number of participating clinical sites and expect to conclude the study in the first half of 2024.”

About AAD
Headquartered in Rosemont, Illinois, the American Academy of Dermatology was founded in 1938. With a membership of more than 20,500 physicians worldwide, the AAD is committed to: advancing the diagnosis and medical, surgical, and cosmetic treatment of the skin, hair, and nails; advocating high standards in clinical practice, education, and research in dermatology; and supporting and enhancing patient care for a lifetime of healthier skin, hair, and nails.

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.

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.

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 pediatric and adult patients 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 unmet needs in medical dermatology. 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 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,” and similar expressions, and are based on Verrica’s current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development and potential benefits of VP-315, including the enrollment 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. 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 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 June 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

What is the name of the company that presented the data?

The company that presented the data is Verrica Pharmaceuticals Inc.

What is the name of the drug being studied?

The drug being studied is VP-315.

What is the indication for VP-315?

VP-315 is being studied for the treatment of basal cell carcinoma (BCC).

What were the results of the study?

The study showed consistent clinical and histological clearance of treated BCC lesions with the 8 mg dose of VP-315. 67% of subjects showed complete tumor clearance.

What is the plan for the next phase of the trial?

The company plans to expand Part 2 of the trial based on the positive results from Part 1.