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news.Arpida has reported that the patient screening for enrollment into the pivotal Phase III study with the TLT treatment in onychomycosis has been initiated and is progressing at a very good rate. Approximately 220 patients in total will be enrolled in this study.
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The open label Phase III study will evaluate the efficacy, safety and tolerability of the TLT therapy in the treatment of patients with mild-to-moderate toenail onychomycosis. The TLT therapy consists of a one-time laser pre-treatment, followed by daily application of a topical terbinafine (the active substance of Lamisil) formulation. The comparator is 8% ciclopirox lacquer (Penlac) applied daily to nails that have not undergone a prior laser pre-treatment. The treatment duration will be 48 weeks in both arms.
The primary efficacy endpoint is complete cure, which is defined as 100% clear nails, negative fungal culture results and negative KOH microscopy. Arpida aims to demonstrate superiority of the TLT therapy over the comparator. Secondary endpoints include time to complete cure as well as safety and tolerability of the TLT treatment.
Paul Hadvary, head of development at Arpida, said: “The TLT therapy as a targeted approach could offer significant advantages by providing effective treatment while at the same time avoiding systemic exposure and bypassing the potential side effects of oral therapies. We are on track to complete this trial by early 2009.”