Hexima announces the completion of enrolment in phase IIb clinical trial

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Clinical stage biotechnology company Hexima (ASX:HXL) says it has completed the enrolment of patients in its phase IIb clinical trial evaluating pezadeftide (HXP124) as a potential new topical treatment for onychomycosis. 

The company said the study is on schedule and Hexima expects to announce results from the trial in the second quarter of 2022.

"This is an important achievement in pezadeftide’s advanced clinical development program," said the company. "Fifteen clinical sites across Australia and New Zealand enrolled a total of 117 patients into the study. Patients were randomly assigned to three different treatment arms. In each treatment arm patients receive either pezadeftide or the vehicle (without pezadeftide) control."

Dr Robert Rosen, the managing director of Southderm Dermatology in Sydney and one of the lead investigators of the HXP124-ONY-002 study, said, “Onychomycosis is a common and difficult to treat condition and we welcome innovation in this area. We look forward to assessing whether pezadeftide applied topically can be a safe and effective treatment for this disease.”

"Hexima expects this phase IIb clinical trial  to represent its last large multi-centre clinical trial ahead of initiating a phase III program in Q3 2022. In preparation, Hexima expects to file an IND with FDA in Q4 2021 and then conduct an FDA-required small single-centre, maximal use, safety study in the US in H1 2022," said the company.

According to CEO Michael Aldridge, “We are very pleased to have completed enrolment in this advanced and comprehensive study, following some early challenges with COVID-19 related lockdowns.

“We expect to build on the very promising preliminary efficacy we saw in our phase I/IIa clinical trial.  Our goal is to demonstrate the potential of pezadeftide to be a safe and effective treatment in a convenient, consumer friendly, topical format for this very common and difficult to treat infectious disease.”

Peter Welburn, Hexima’s chief development officer added, “The results of this study will be pivotal in determining the optimal dosing strategy for our global phase III program and we anticipate entering discussions with FDA in the second half of 2022.”