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Verrica Pharmaceuticals Announces Positive Topline Results in Phase 2 Clinical Study of VP-102 in Patients with External Genital Warts (CARE-1)
- 35% of subjects treated with VP-102 achieved complete clearance of all treatable genital warts vs 2.4% for vehicle (p=0.0001) - - VP-102 was well-tolerated
About this update from Verrica Pharmaceuticals Inc.
[{"type":"text","content":"- 35% of subjects treated with VP-102 achieved complete clearance of all treatable genital warts vs 2.4% for vehicle (p=0.0001) -\n - VP-102 was well-tolerated with no reported serious adverse events related to VP-102 - - Approximately 500,000 to 1 million cases of EGW are newly diagnosed per year in the United States - - Based on positive outcome, Verrica will request an End-of-Phase 2 meeting with the FDA - WEST CHESTER, Pa., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (Verrica) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced positive topline results from its Phase 2 CARE-1 clinical study of VP-102, a novel topical therapy containing a solution of 0.7% (w/v) cantharidin in a proprietary single-use applicator, in external genital warts (EGW). VP-102 achieved positive results on both the primary endpoint of complete clearance of all treatable EGW at Day 84 and the secondary endpoint of the percentage reduction of EGW at Day 84. “The positive results of the Phase 2 CARE-1 trial suggest that VP-102 has the potential to provide patients and physicians with a well-tolerated and effective option for treatment,” said Gary Goldenberg, MD, Chief Medical Officer of Verrica. “Based on the positive outcome from CARE-1, we intend to request an End-of-Phase 2 meeting with the FDA for the treatment of EGW in the first quarter of 2021.” “EGW, otherwise known as condyloma acuminata, are one of the most common sexually-transmitted infections in the U.S., often resulting in substantial social stigma, negative impact on quality of life, and an increased risk of HPV-related cervical cancer,” said Neal Bhatia, MD, Director of Clinical Dermatology at Therapeutics Clinical Research in San Diego. “Undertreatment of EGW presents an interdisciplinary public health issue, as patients often seek treatment from a variety of sources including dermatologists, urologists, gynecologists, and primary care physicians. Newer medical therapeutic advances may offer more tolerable and effective approaches to controlling the spread of EGW and therefore can improve outcomes for these patients.” CARE-1 was a Phase 2, double-blind, vehicle-controlled clinical study of VP-102 to determine the dose regimen, efficacy, safety, and tolerability of VP-102 in subjects...