Verrica Pharmaceuticals has reported positive results from the pivotal Phase III CAMP-1 and CAMP-2 clinical trials of VP-102 to treat molluscum contagiosum, a type of contagious, viral skin infection.
Both trials met their primary endpoint, where a clinically and statistically significant proportion of subjects who received VP-102 experienced complete clearance of all treatable molluscum lesions at 12 weeks.
The company noted that the infection takes an average of about 13 months, or several years in some cases, for resolution without treatment.
VP-102 is a topical therapy comprising a 0.7% cantharidin solution in a single-use applicator. It is intended for treating molluscum, verruca vulgaris and external genital warts.
The two randomised, double-blind, multi-centre, placebo-controlled Phase III trials assessed the efficacy of dermal VP-102 application compared to placebo in a total of 528 patients aged two years and above at 31 sites in the US.
Nearly 46% and 54% of patients treated with VP-102 experienced complete clearance of all treatable molluscum lesions in the CAMP-1 and CAMP-2 trials respectively, compared to 18% and 13% in the placebo arm.
The VP-102 group also achieved a 69% and 83% mean reduction in the number of molluscum lesions in CAMP-1 and CAMP-2 respectively.
Verrica Pharmaceuticals president and CEO Ted White said: “Complete clearance of molluscum lesions in a short amount of time is important to patients, especially parents of young children who are impacted by this highly contagious skin infection.
“These important data reinforce the potential for VP-102 as a first-in-class topical therapy to become the standard of care for molluscum.”
VP-102 was found to be well-tolerated in both trials, with no serious adverse events recorded.
Results from the trials have been presented at the American Academy of Dermatology (AAD) annual meeting being held in Washington, DC, US from 1-5 March.
Based on the positive data, Verrica intends to submit a new drug application (NDA) to the US Food and Drug Administration (FDA) in the second half of this year.