Japanese trial shows TO-208 efficacious in molluscum contagiosum
Key takeaways:
- Phase 3 results show a statistical improvement in molluscum contagiosum during TO-208 treatment vs. placebo.
- Torii Pharmaceuticals plans on submitting a manufacturing and marketing application for TO-208.
Torii Pharmaceutical Co. Ltd. has reported positive top-line results for a phase 3 trial evaluating TO-208 for the treatment of molluscum contagiosum in Japan, Verrica Pharmaceuticals announced in a press release.
In March 2021, Torii Pharmaceutical, a partner of Verrica Pharmaceuticals, signed an exclusive licensing agreement for the development and commercialization of TO-208 (cantharidin) — also known as VP-102 and marketed as Ycanth in the United States — in Japan, where the company then conducted a double-blind, randomized, parallel-group, phase 3 study to evaluate TO-208 for the treatment of molluscum contagiosum.
“We are obviously excited by the positive results from this confirmatory phase 3 trial for TO-208 for the treatment of molluscum in Japan, which underscores the consistent safety and efficacy of VP-102 and FDA-approved Ycanth,” Ted White, CEO of Verrica Pharmaceuticals, said in the press release.
In the trial, patients with molluscum contagiosum applied TO-208 or placebo once every 21 days for up to four applications. The results showed that a statistically significant proportion of patients treated with TO-208 achieved complete clearance compared with placebo.
Based on the results of this phase 3 trials, Torii plans on submitting a manufacturing and marketing application for TO-208 in Japan.