Verrica Pharmaceuticals’ lead candidate, a drug-device combination for dermatology indications, hit its primary endpoints in two phase 3 trials testing it in the skin infection molluscum contagiosum. The treatment beat out placebo in completely clearing treatable lesions and reducing the number of lesions in both studies.
The West Chester, Pennsylvania-based company plans to file an NDA for the asset, dubbed VP-102, in the second half of 2019.
VP-102 is being developed for common warts, plantar and external genital warts, as well as molluscum, a contagious viral skin infection most commonly seen in children. The skin lesions tend to clear on their own, but this can take a year or longer, and during that time, skin-to-skin contact can spread the virus to other people or to parts of a person’s body that aren’t infected. There is no FDA-approved treatment for molluscum, though dermatologists may treat the lesions using methods such as curettage—scraping the bumps from the skin—or freezing them off with liquid nitrogen.
“Current methods of treatment have significant limitations including pain, scarring, unproven efficacy and many are unsuitable for use in children,” said Lawrence Eichenfield, M.D., chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego and lead investigator for the VP-102 phase 3 molluscum program, in a statement. “VP-102 addresses an unmet medical need to treat these serious skin lesions which can quickly spread among children and within families, and when left untreated, can lead to social stigma, anxiety, skin inflammation and secondary infections.”
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The data, presented on Saturday at the annual meeting of the American Academy of Dermatology, follow topline results announced in January. Both trials, called CAMP-1 and CAMP-2, were randomized, double-blind placebo-controlled trials that pitted VP-102 against placebo in a total of 528 patients with molluscum. VP-102 is a topical treatment containing a solution of 0.7% cantharidin in a single-use applicator.
Patients were treated once every three weeks for up to a total of 12 weeks. By the end of the study, 46% of treated patients in CAMP-1 and 54% of treated patients in CAMP-2 had complete clearance of all treatable molluscum lesions. The numbers for the placebo groups were 18% and 13%, respectively. VP-102 performed similarly in the mean reduction of the number of lesions: 69% and 83% reduction in CAMP-1 and CAMP-2. Placebo patients in CAMP-1 had a 20% increase in lesions, while those in CAMP-2 had a 19% reduction.
“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,” said Verrica CEO Ted White in the statement. “These important data reinforce the potential for VP-102 as a first-in-class topical therapy to become the standard of care for molluscum.”
Verrica filed in May 2018 to raise up to $86 million in its IPO to push VP-102 through phase 3 and onto the market. In June, it priced the IPO in the middle of its range, reeling in $75 million.