Date: 2016-08-10
Type of information: Clinical trial authorization
phase: 3
Announcement: clinical trial authorization
Company: Moberg Pharma (Sweden)
Product: MOB-015 (topical formulation of terbinafine)
Action
mechanism: antifungal agent. MOB-015 is an internally developed topical formulation of terbinafine building on Moberg Pharma’s experience from its leading OTC product Kerasal Nail®. Oral terbinafine is the gold standard for treating onychomycosis, but associated with safety issues including drug interactions and liver damage.
Disease: onychomycosis
Therapeutic area: Infectious diseases
Country: Canada, Germany, Poland, USA
Trial details:
Latest
news: * On August 10, 2016, Moberg Pharma announced that the FDA has approved the Company’s Investigational New Drug (IND) application and that a No Objection Letter has been received from Health Canada to begin its Phase 3 trial for MOB-015 in the treatment of onychomycosis. This allows Moberg Pharma to start enrolling patients in the U.S. and Canada pending approval from the Institutional Review Board (IRB/independent ethics committee). The approvals concern a randomized, multicenter, vehicle-controlled Phase 3 study. The patients will be evaluated over 52 weeks and the primary endpoint will be the proportion of patients achieving complete cure of their target nail. The company expects to start enrollment in the third quarter of this year. * On July 5, 2016, Moberg Pharma announced it has submitted an Investigational New Drug (IND) application to the FDA for MOB-015 in the treatment of onychomycosis. In addition, the Company has submitted Clinical Trial Applications to the regulatory authorities in Germany, Poland and Canada. The applications concern two randomized, multicenter, controlled Phase 3 studies. In total, approximately 675 subjects will be evaluated over 52 weeks and the primary endpoint will be the proportion of subjects achieving complete cure of their target nail. The company expects to start enrolling patients in the third quarter of this year.
