Benzinga | Nov 10, 2020 07:34AM EST

Verrica Pharmaceuticals Announces Topline Results In Phase 2 Clinical Study Of VP-102 In Patients With External Genital Warts; Says Achieved Positive Results On Primary And Secondary Endpoints

- 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 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 with EGW in subjects 18 years of age or older. The study included two sequential parts: Part A and Part B. Part A was conducted in 18 subjects at four research sites. Subjects received treatment with VP-102 to treatable EGW every 21 days for up to four treatments and were told to wash off VP-102 within either 2, 6, or 24 hours of application. Safety results from Part A supported use of VP-102 for both 6-hour and 24-hour treatment exposures in Part B.

Part B was conducted in an additional 87 subjects at nine research sites comparing vehicle to VP-102 applied for either 6 or 24 hours for up to four treatments. The primary analyses were conducted at Day 84. Topline analyses included data from the assessment of EGW at study visits at days 21, 42, 63, and 84.

Study Results and Demographics:

* Subjects presented with a mean wart count of 8.2 with a range of 2 to 30 EGW at baseline. Approximately 50% of subjects had EGW for one year or longer; approximately 23% of subjects had EGW for more than five years.

* Pooled results from the 6- and 24-hour treatment exposures showed 35.1% (20/57) of subjects treated with VP-102 achieved complete clearance of all treatable EGW at Day 84 compared to 2.4% (1/42) of subjects treated with vehicle (p=0.0001).

* For both the 6- and 24-hour treatment exposures, subjects treated with VP-102 achieved statistically significantly larger reductions in percent change from baseline in the number of treatable EGW compared to vehicle at Day 84: 6-hour (p< 0.0001), 24-hour group (p=0.0003).

* VP-102 was well-tolerated. Side effects experienced by the VP-102 treated subjects were consistent with the pharmacodynamic action of cantharidin as a blistering agent. These side effects were primarily mild-to-moderate and included application site vesicles, pain and erythema. No subjects discontinued from the study due to adverse events and there were no serious adverse events reported that were considered related to treatment by the investigator.

In addition to requesting an End-of-Phase 2 meeting with the FDA on next steps for the development of VP-102 for the treatment of EGW, Verrica plans to submit the Phase 2 CARE-1 data for presentation at future medical meetings and for publication in a peer-reviewed medical journal.