Hexima Limited announced the results of its phase II clinical study of pezadeftide (HXP124) for the treatment of onychomycosis (HXP124-ONY-002). HXP124-ONY-002 was designed and conducted as a phase II, multi-centre, randomized, double-blind, vehicle-controlled study to investigate the efficacy, safety and tolerability of pezadeftide (HXP124) in three dosing cohorts in patients with mild to moderate onychomycosis. Subjects were randomised to receive once daily topical application of 2% (20 mg/mL) pezadeftide or vehicle to all infected toenails in one of three cohorts (randomization 3:1 pezadeftide to vehicle): Cohort 1: 2 treatment periods of 6 weeks; N=29 pezadeftide, 9 vehicle Cohort 2: 2 treatment periods of 6 weeks plus once-weekly maintenance dosing for 23 weeks; N=30 pezadeftide, 10 vehicle Cohort 3: 5 treatment periods of 6 weeks plus 1 treatment period of 1 week; N=30 pezadeftide, 9 vehicle.
A total of 117 patients were enrolled; 14 were withdrawn or dropped out prior to completing the study. Patients were assessed for safety and efficacy at scheduled visits (weeks 13, 24, 36) during the course of the study and at the final follow-up visit at week 40. Inclusion and exclusion criteria were generally consistent with those adopted in pivotal clinical studies of the leading branded topical product in the US market.
There was a balanced distribution of patients between cohorts according to age, weight, height, and BMI, 80% were male, 20% female and 89% of enrolled patients were Caucasian. Completers were defined as having complied and received 85% or more of drug doses. Pezadeftide was well-tolerated and safe, with only three Serious Adverse Events (fall, angina and depression) reported and none reported as drug-related.
Overall, Adverse Events (144) were primarily mild, with no unexpected Treatment Emergent Adverse Events, and were similar in reported and observed for pezadeftide and vehicle-treated patients, regardless of Cohort. The summary of efficacy as at week 40 is shown in the table below. These endpoints are the pre- defined efficacy parameters in the phase II study and are as defined by FDA.
There was no consistent effect observed in pezadeftide-treated patients at week 40 compared to vehicle-treated, with the best efficacy results observed in Cohort 2.