Verrica Pharmaceuticals Announces Acceptance of Two Abstracts Featuring Positive Preliminary Topline Results of VP-315 for the Treatment of Basal Cell Carcinoma at the 2024 Fall Clinical Dermatology Conference
Verrica Pharmaceuticals (NASDAQ: VRCA) announced positive preliminary results from Part 2 of their Phase 2 study for VP-315, a novel oncolytic peptide treatment for basal cell carcinoma (BCC). The study, involving 82 patients with 92 tumors, showed that 51% of treated tumors achieved complete histological clearance, while patients with residual tumors experienced an average 71% reduction in tumor size. The treatment demonstrated a favorable safety profile with no serious adverse events. Two abstracts featuring these results will be presented at the 2024 Fall Clinical Dermatology Conference. The company plans to request an FDA End-of-Phase 2 meeting in first half 2025, targeting the 3-4 million annual BCC cases in the U.S.
Verrica Pharmaceuticals (NASDAQ: VRCA) ha annunciato risultati preliminari positivi dalla Parte 2 del loro studio di Fase 2 per VP-315, un nuovo trattamento peptidico oncolitico per il carcinoma basocellulare (BCC). Lo studio, che ha coinvolto 82 pazienti con 92 tumori, ha mostrato che il 51% dei tumori trattati ha raggiunto una completa clearance istologica, mentre i pazienti con tumori residui hanno sperimentato una riduzione media del 71% della dimensione del tumore. Il trattamento ha dimostrato un profilo di sicurezza favorevole, senza eventi avversi gravi. Due abstract contenenti questi risultati saranno presentati alla Conferenza Clinica di Dermatologia dell'Autunno 2024. L'azienda prevede di richiedere un incontro con la FDA per la fine della Fase 2 nella prima metà del 2025, puntando ai 3-4 milioni di casi annuali di BCC negli Stati Uniti.
Verrica Pharmaceuticals (NASDAQ: VRCA) anunció resultados preliminares positivos de la Parte 2 de su estudio de Fase 2 para VP-315, un nuevo tratamiento de péptidos oncolíticos para el carcinoma basocelular (BCC). El estudio, que involucró a 82 pacientes con 92 tumores, mostró que el 51% de los tumores tratados logró una eliminación histológica completa, mientras que los pacientes con tumores residuales experimentaron una reducción promedio del 71% en el tamaño del tumor. El tratamiento demostró un perfil de seguridad favorable sin eventos adversos graves. Dos resúmenes con estos resultados se presentarán en la Conferencia Clínica de Dermatología de Otoño 2024. La compañía planea solicitar una reunión con la FDA al final de la Fase 2 en la primera mitad de 2025, con un objetivo de 3-4 millones de casos anuales de BCC en los EE.UU.
베리카 제약 (NASDAQ: VRCA)는 기저세포암(BCC)을 위한 새로운 온콜리틱 펩타이드 치료제인 VP-315의 2단계 임상시험 파트 2에서 긍정적인 초기 결과를 발표했습니다. 92개의 종양을 가진 82명의 환자가 참여한 이 연구에서 치료된 종양의 51%가 완전한 조직학적 제거를 달성한 반면, 잔여 종양이 있는 환자는 종양 크기가 평균 71% 감소했습니다. 이 치료는 심각한 부작용 없이 안전성을 보여주었습니다. 이러한 결과를 담은 두 개의 초록이 2024 가을 임상 피부과 회의에서 발표될 예정입니다. 회사는 2025년 상반기에 FDA와의 임상 2단계 종료 회의를 요청할 계획이며, 미국에서 연간 300-400만 건의 BCC 사례를 목표로 하고 있습니다.
Verrica Pharmaceuticals (NASDAQ: VRCA) a annoncé des résultats préliminaires positifs de la Partie 2 de son étude de Phase 2 pour VP-315, un nouveau traitement péptidique oncolytique pour le carcinome basocellulaire (BCC). L'étude, impliquant 82 patients avec 92 tumeurs, a montré que 51% des tumeurs traitées avaient atteint une élimination histologique complète, tandis que les patients ayant des tumeurs résiduelles ont connu une réduction moyenne de 71% de la taille de la tumeur. Le traitement a montré un profil de sécurité favorable sans événements indésirables graves. Deux résumés contenant ces résultats seront présentés lors de la Conférence Clinique de Dermatologie de l'Automne 2024. L'entreprise prévoit de demander une réunion de fin de Phase 2 avec la FDA au cours du premier semestre 2025, visant les 3 à 4 millions de cas annuels de BCC aux États-Unis.
Verrica Pharmaceuticals (NASDAQ: VRCA) gab positive vorläufige Ergebnisse aus Teil 2 ihrer Phase-2-Studie zu VP-315, einer neuartigen onkolytischen Peptidbehandlung für das Basalzellkarzinom (BCC), bekannt. Die Studie, an der 82 Patienten mit 92 Tumoren teilnahmen, zeigte, dass 51% der behandelten Tumoren eine vollständige histologische Clearance erreichten, während Patienten mit residuellen Tumoren eine durchschnittliche Tumorgröße von 71% reduzierten. Die Behandlung wies ein günstiges Sicherheitsprofil auf und es traten keine schwerwiegenden unerwünschten Ereignisse auf. Zwei Abstracts mit diesen Ergebnissen werden auf der Dermatologischen Konferenz im Herbst 2024 präsentiert. Das Unternehmen plant, im ersten Halbjahr 2025 ein Treffen mit der FDA zum Ende der Phase 2 zu beantragen, wobei es die 3-4 Millionen jährlichen BCC-Fälle in den USA ins Visier nimmt.
- 51% of treated tumors achieved complete histological clearance
- 71% average reduction in tumor size for patients with residual tumors
- No treatment-related serious adverse events reported
- Large market opportunity targeting 3-4 million annual BCC cases in U.S.
- 49% of treated tumors did not achieve complete clearance
Insights
The Phase 2 results for VP-315 demonstrate promising efficacy in treating basal cell carcinoma (BCC), with
These preliminary results are particularly significant given BCC's high prevalence, with 3-4 million cases diagnosed annually in the U.S. The non-surgical nature of VP-315, administered via direct tumor injection, could represent a paradigm shift in BCC treatment, especially for patients seeking alternatives to surgery.
However, investors should note that further validation is needed through upcoming genomic and T-cell data in Q1 2025, followed by an FDA End-of-Phase 2 meeting. The path to commercialization still requires successful Phase 3 trials and regulatory approval.
The commercial potential for VP-315 is substantial in the multi-billion-dollar BCC market. With 3-4 million annual U.S. cases, even modest market penetration could generate significant revenue for a company with a market cap of just
The positive Phase 2 data could attract partnership interest from larger pharmaceutical companies, given the significant market opportunity and the need for non-surgical alternatives in BCC treatment. However, investors should consider that commercialization is still years away, requiring substantial capital for Phase 3 trials and potential marketing efforts.
- Posters to highlight the safety data, tolerability data, and antitumor efficacy data of VP-315 for the treatment of basal cell carcinoma as determined by histological clearance -
WEST CHESTER, Pa., Oct. 24, 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 the acceptance of two abstracts that will be presented as posters at the Fall Clinical Dermatology Conference, which is being held from October 24-27, 2024, in Las Vegas, Nevada. The posters will feature clinical data from Part 2 of the Company’s Phase 2 study of the Company’s novel oncolytic peptide, VP-315, for the treatment of basal cell carcinoma (“BCC”).
The presentations are titled “Results of a Phase 2 Multicenter Study Evaluating the Safety and Tolerability of VP-315, an Investigational therapy for Basal Cell Carcinoma” and “Results of a Phase 2 Multicenter Study to Evaluate the Efficacy of VP-315, an Investigational therapy for Basal Cell Carcinoma”. The posters will include safety and histologic clearance data from 82 patients with up to 2 target BCC tumors (total 92 tumors) in Part 2 of the Phase 2 study evaluating VP-315 for the treatment of BCC, including patients with tumors on the head and neck.
Part 2 of the Phase 2 trial was designed to further explore dosing regimens to help identify the recommended regimen for a Phase 3 study program. Approximately
“We believe the positive preliminary topline results from Part 2 of the Phase 2 study for VP-315 are a meaningful step forward in potentially providing BCC patients with additional treatment options,” said Ted White, President and Chief Executive Officer of Verrica. “We are encouraged by our preliminary results, which we believe support the use of VP-315 as a first line therapy for use in both primary, and neoadjuvant settings. As a novel oncolytic peptide administered directly into the tumor, VP-315 has the potential to offer a non-surgical alternative for the three to four million cases of BCC diagnosed in the U.S. each year, representing a multi-billion-dollar commercial opportunity for Verrica.”
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 BCC. The study enrolled 92 adult subjects with a histological diagnosis of BCC 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 chemotherapeutic peptide immunotherapy administered directly into a tumor to induce immunogenic cell death and thereby unleashing a broad spectrum of tumor antigens for T cell responses, 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. 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. Verrica’s product YCANTH® (VP-102) (cantharidin), is the first and only commercially available 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. YCANTH® (VP-102) is also in development to treat common warts and external genital warts, two of the largest remaining 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 non-melanoma skin cancers including basal cell carcinoma and squamous cell carcinoma. 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 statements concerning the potential of VP-315, the Company’s research, development and regulatory plans for VP-315, the timing of the Company’s planned clinical trials for VP-315 and reporting data from the Company’s clinical trials, and the potential market size opportunity for the treatment of basal cell carcinoma. 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 Vernica’s Annual Report on Form 10-K for the year ended December 31, 2023, Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 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:
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com
Chris Calabrese
LifeSci Advisors
ccalabrese@lifesciadvisors.com
FAQ
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