Celtic Pharmaceutical, a private equity firm focused on the biotechnology and pharmaceutical industries, has enroled the first patient into its Phase III trial of TDT 067, terbinafine in Transfersomes, for the topical treatment of onychomycosis or fungal nail infection.
The trial is a three-arm, double-blind study to be conducted in approximately 40 centres around the world.
It is powered to provide potentially registrational data on the efficacy, tolerability and safety of topically applied terbinafine delivered through the Transfersome targeted delivery technology over 48 weeks.
PPD, a contract research organisation, has been appointed to conduct the study.
Dr. Phoebe Rich of Oregon Dermatology and Research Center, Oregon Health and Sciences University, the principal investigator for North America, says: "This important trial uses exciting new technology to deliver antifungal drug deep into the site of infection in the nail. This drug could potentially address the huge unmet need for topical therapy for onychomycosis.”
John Mayo and Stephen Evans Freke, managing general partners, Celtic Pharma, said: “We are delighted to progress to Phase III clinical development of TDT 067, where we anticipate confirmation that this is a medically and commercially important advance in the treatment of this common disease. Based on what we have seen in Phase II development, we believe that we have a product candidate that is comparable in efficacy to currently available oral therapy but without the potential for serious safety issues.”
