Verrica Pharmaceuticals Announces Presentation of Three Posters Featuring Positive Preliminary Topline Results of VP-315 for the Treatment of Basal Cell Carcinoma at the 2025 Winter Clinical Dermatology Conference
Verrica Pharmaceuticals (NASDAQ: VRCA) presented three posters featuring clinical data from Part 2 of their Phase 2 study of VP-315, a novel oncolytic peptide for treating basal cell carcinoma (BCC), at the 2025 Winter Clinical Dermatology Conference. The study, involving 82 patients with 91 tumors, demonstrated a 97% Calculated Objective Response Rate.
Key findings include: 51% of tumors achieved complete histological clearance, while remaining patients showed an average 71% reduction in tumor size. The treatment showed favorable safety profiles with no Treatment Related Serious Adverse Events, and mostly mild to moderate adverse events.
The company plans to request an End-of-Phase 2 meeting with the FDA in first half of 2025, with genomic and T-cell data expected in Q1 2025. Verrica believes VP-315 could serve as a first-line therapy in both primary and neoadjuvant settings, potentially representing a multi-billion-dollar opportunity as a non-surgical alternative for BCC patients.
Verrica Pharmaceuticals (NASDAQ: VRCA) ha presentato tre poster contenenti dati clinici della Parte 2 del loro studio di Fase 2 su VP-315, un nuovo peptide oncolitico per il trattamento del carcinoma basocellulare (BCC), alla Conferenza Clinica Invernale di Dermatologia del 2025. Lo studio ha coinvolto 82 pazienti con 91 tumori, dimostrando un tasso di risposta obiettiva calcolato del 97%.
I risultati chiave includono: il 51% dei tumori ha raggiunto una completa clearance istologica, mentre i restanti pazienti hanno mostrato una riduzione media del 71% delle dimensioni del tumore. Il trattamento ha mostrato profili di sicurezza favorevoli, senza eventi avversi seri correlati al trattamento, e la maggior parte degli eventi avversi è risultata lieve o moderata.
L'azienda prevede di richiedere un incontro di fine Fase 2 con la FDA nella prima metà del 2025, con dati genomici e sulle cellule T attesi per il primo trimestre del 2025. Verrica crede che VP-315 potrebbe essere utilizzato come terapia di prima linea sia in contesti primari che neoadiuvanti, rappresentando potenzialmente un'opportunità da miliardi di dollari come alternativa non chirurgica per i pazienti con BCC.
Verrica Pharmaceuticals (NASDAQ: VRCA) presentó tres carteles con datos clínicos de la Parte 2 de su estudio de Fase 2 sobre VP-315, un nuevo péptido oncolítico para el tratamiento del carcinoma basocelular (BCC), en la Conferencia Clínica Dermatológica de Invierno de 2025. El estudio, que incluyó a 82 pacientes con 91 tumores, demostró una tasa de respuesta objetiva calculada del 97%.
Los hallazgos clave incluyen: el 51% de los tumores logró una completa eliminación histológica, mientras que los pacientes restantes mostraron una reducción promedio del 71% en el tamaño del tumor. El tratamiento mostró perfiles de seguridad favorables sin eventos adversos serios relacionados con el tratamiento, y la mayoría de los eventos adversos fueron leves o moderados.
La compañía planea solicitar una reunión de fin de Fase 2 con la FDA en la primera mitad de 2025, con datos genómicos y de células T esperados para el primer trimestre de 2025. Verrica cree que VP-315 podría servir como terapia de primera línea tanto en entornos primarios como neoadyuvantes, representando potencialmente una oportunidad de miles de millones de dólares como una alternativa no quirúrgica para los pacientes con BCC.
버리카 제약 (NASDAQ: VRCA)는 2025년 겨울 임상 피부과 회의에서 기초 세포 암종(BCC) 치료를 위한 새로운 항종양 펩타이드인 VP-315의 2상 연구 파트 2의 임상 데이터가 포함된 3개의 포스터를 발표했습니다. 이 연구는 91개의 종양을 가진 82명의 환자를 포함하며 97%의 계산된 객관적 반응률을 보여주었습니다.
주요 결과에는 51%의 종양이 완전 조직학적 제거에 도달했으며, 나머지 환자들은 평균 71%의 종양 크기 감소를 보였습니다. 치료는 치료 관련 심각한 부작용이 없고 대부분 경미한 또는 중등도의 부작용으로 안전성 프로파일이 좋았습니다.
회사는 2025년 상반기 내에 FDA와의 2상 종료 회의를 요청할 계획이며, 2025년 1분기에 유전자 및 T세포 데이터를 예상하고 있습니다. 버리카는 VP-315가 1차 및 보조 치료 설정 모두에서 1차 요법으로 활용될 수 있으며, BCC 환자를 위한 비수술적 대안으로 수십억 달러 규모의 기회를 나타낼 수 있다고 믿고 있습니다.
Verrica Pharmaceuticals (NASDAQ: VRCA) a présenté trois affiches contenant des données cliniques de la Partie 2 de leur étude de Phase 2 sur VP-315, un nouveau peptide oncolytique pour le traitement du carcinome basocellulaire (BCC), lors de la Conférence Clinique Dermatologique d'Hiver 2025. L'étude, impliquant 82 patients avec 91 tumeurs, a démontré un taux de réponse objective calculé de 97%.
Les conclusions clés incluent : 51% des tumeurs ont atteint une élimination histologique complète, tandis que les patients restants ont montré une réduction moyenne de 71% de la taille de la tumeur. Le traitement a présenté des profils de sécurité favorables sans événements indésirables graves liés au traitement, et la plupart des événements indésirables étaient légers à modérés.
L'entreprise prévoit de demander une réunion de fin de Phase 2 avec la FDA au cours de la première moitié de 2025, avec des données génomiques et sur les cellules T attendues au premier trimestre 2025. Verrica estime que VP-315 pourrait servir de thérapie de première ligne tant dans des contextes primaires que néoadjuvants, représentant potentiellement une opportunité de plusieurs milliards de dollars comme alternative non chirurgicale pour les patients atteints de BCC.
Verrica Pharmaceuticals (NASDAQ: VRCA) hat auf der Winter Clinical Dermatology Conference 2025 drei Poster mit klinischen Daten aus Teil 2 ihrer Phase-2-Studie zu VP-315, einem neuartigen onkolytischen Peptid zur Behandlung von Basalzellkarzinomen (BCC), präsentiert. Die Studie umfasste 82 Patienten mit 91 Tumoren und zeigte eine 97% berechnete objektive Ansprechrate.
Wichtige Ergebnisse umfassen: 51% der Tumoren erreichten eine vollständige histologische Beseitigung, während die übrigen Patienten eine durchschnittliche 71%ige Reduzierung der Tumorgröße zeigten. Die Behandlung wies ein günstiges Sicherheitsprofil auf, ohne behandlungsbedingte schwerwiegende unerwünschte Ereignisse, und größtenteils milde bis moderate Nebenwirkungen.
Das Unternehmen plant, in der ersten Hälfte von 2025 ein Treffen zum Abschluss der Phase 2 mit der FDA zu beantragen, wobei genomische und T-Zell-Daten im ersten Quartal 2025 erwartet werden. Verrica glaubt, dass VP-315 sowohl als Erstlinientherapie in primären als auch neoadjuvanten Szenarien dienen könnte, was potenziell eine milliardenschwere Gelegenheit als nicht-chirurgische Alternative für BCC-Patienten darstellt.
- 97% Calculated Objective Response Rate in Phase 2 study
- 51% of tumors achieved complete histological clearance
- 71% average reduction in tumor size for remaining patients
- No Treatment Related Serious Adverse Events reported
- Potential multi-billion-dollar commercial opportunity
- 49% of tumors did not achieve complete clearance
- Phase 3 study design and timeline still pending FDA discussion
Insights
The Phase 2 study results for VP-315 demonstrate remarkable potential in treating basal cell carcinoma (BCC). The 97% Calculated Objective Response Rate is particularly impressive for an oncology treatment. Breaking this down into plain terms - almost every patient showed meaningful tumor shrinkage or elimination.
Key findings that make this significant:
- 51% complete histological clearance - meaning the cancer was completely eliminated in these cases
- 71% average tumor reduction in remaining cases
- Strong safety profile with no serious treatment-related adverse events
For context, current BCC treatments often involve surgical removal, which can be invasive and leave scarring. A non-surgical alternative showing these efficacy levels could revolutionize treatment approaches. The multi-billion dollar commercial opportunity cited is realistic given that BCC is the most common form of skin cancer, with millions of new cases annually in the US alone.
From a market perspective, these results could significantly impact Verrica's valuation, currently at just
- Annual BCC diagnoses number in the millions in the US
- Current treatment costs range from
$5,000 to over$25,000 per case - Growing elderly population driving increased BCC incidence
The planned FDA End-of-Phase 2 meeting in H1 2025 is a important catalyst. Success could accelerate the path to Phase 3 trials. For a small-cap company like Verrica, having a potential blockbuster drug showing strong efficacy in Phase 2 typically attracts significant investor attention and potential partnership opportunities with larger pharmaceutical companies.
The clinical implications of VP-315's performance are substantial. In dermatological oncology, achieving a
The
The upcoming genomic and T-cell data in Q1 2025 will be important in understanding the mechanism of action and potentially expanding applications. This could open doors for combination therapies or treatment of other skin cancers.
– Presented data includes a
– Posters 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., Jan. 21, 2025 (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 three posters that were presented at the 2025 Winter Clinical Dermatology Conference, which was held from January 17-19, in Miami, Florida. The posters featured clinical data from Part 2 of the Phase 2 study (the “Study”) of the Company’s novel oncolytic peptide, VP-315, for the treatment of basal cell carcinoma (“BCC”).
Verrica presented a poster titled “Calculated Objective Response Rate (ORR) of
Part 2 of the Study was designed to explore dosing regimens to help Verrica identify the recommended regimen for a Phase 3 study program. Approximately
In the newly-presented poster, Verrica conducted a post-hoc analysis of the data from the Study and announced a Calculated ORR of
“We remain highly encouraged by the positive preliminary topline results from Part 2 of the Phase 2 study for VP-315, which we believe support a potential change in the treatment paradigm for patients with basal cell carcinoma,” said Dr. Jayson Rieger, PhD, MBA, President and Chief Executive Officer of Verrica. “We believe these results will support the use of VP-315 as a potential first line therapy for use in both primary and neoadjuvant settings, and that VP-315 could provide the millions of basal cell carcinoma patients diagnosed in the United States each year with a non-surgical alternative to painful, invasive surgical treatments. We believe that VP-315 could represent a multi-billion-dollar commercial opportunity for Verrica. We look forward to our discussions with the FDA about designing a development path forward for VP-315 in 2025.”
About the Phase 2 Study of VP-315
The Study 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 tumor. 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 holds an exclusive worldwide license to develop and commercialize VP-315 for certain 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 United States, and its incidence is rising worldwide. There are approximately 3-4 million diagnoses of basal cell carcinoma 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 September 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
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