FDA rejects Verrica’s skin warts pitch, a month after flagging application ‘deficiencies’
Two years ago, Verrica Pharma landed a $75 million IPO on the promise they could develop the first ever-FDA approved drug for molluscum contagiosum, an infection that causes warts. Now that won’t happen, at least not this summer.
The FDA today rejected Verrica’s application to have their lead topical drug VP-102 approved for molluscum contagiosum. The news likely came as little surprise to Verrica or its investors; the biotech disclosed in late June that the FDA sent a letter saying “deficiencies” in their application precluded a discussion around labeling or post-marketing commitments.
Verrica said the FDA wanted more information on CMC — chemistry, manufacturing and controls — along with human factors, i.e. how a user will actually handle the product in the real world. In the June letter, Verrica said the FDA had raised concerns about a change the company had made after it became clear that a certain safety issue could arise if healthcare workers did not correctly follow the instructions for applying their therapy. Verrica added a feature to address that issue, but that feature affected human factors testing and required “additional stability data.”
The company said “the FDA did not identify any clinical deficiencies.” They are scheduling a meeting with the agency shortly to discuss next steps.
“We are confident that we can work closely with the FDA to fully address the issues raised in the letter and we continue to believe VP-102 remains viable for FDA approval,” CEO Ted White said.
Despite the rejection, Verrica’s stock stayed buoyant, dipping just 3% on the news. That’s perhaps because the company is aiming for other indications and because the data from pivotal trials for VP-102 bolster the odds of eventual approval.
In one Phase III study released last summer, 46% of patients who received VP-102 saw their warts clear completely, compared to 18% for placebo. In a second Phase III trial, 54% saw complete clearance, compared to 13% for placebo. Overall, patients who received the drug saw a 69% and 83% reduction in lesions, respectively.
Verrica is also now testing VP-102 in common warts. Most recently, they announced that, in an open-label Phase II study, 51% of patients who received the high dose of the drug saw complete clearance of their lesions by day 84. They will use that dose in a Phase III trial. A Phase II trial in genital warts is also ongoing, and a Phase II for plantar warts will start soon.