Enrollment "well on track" for Ph III TLT trial

Swiss biotechnology firm Arpida has initiated patient screening for enrolment into a pivotal Phase III study of its TLT treatment in onychomycosis. Approximately 220 patients in total will be enrolled in this study and a substantial number have already expressed their interest in participating well in advance of the trial, the firm noted.

The open-label, 48-week, Phase III study will evaluate the efficacy, safety and tolerability of TLT, which consists of a one-time laser pre-treatment, followed by daily application of a topical formulation of Novartis' off-patent antifungal Lamisil (terfenadine) in mild-to-moderate toenail onychomycosis. The comparator is Aventis' Penlac Nail Laquer (8% cicloprox) applied daily to nails that have not undergone a prior laser pre-treatment.