OliX said Tuesday that it has obtained ethics committee approval from the Northern B Health and Disability Ethics Committee (HDEC) in New Zealand regarding the Phase 2a clinical trial of its macular degeneration treatment, 'OLX301A'.
Following the approval of the Phase 2a clinical trial protocol in Australia last month, OliX's OLX301A has demonstrated its potential by securing ethics committee approval in New Zealand. The company is proceeding with global clinical development as planned, including having previously submitted a Phase 2a Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA).
This New Zealand HDEC approval is the result of resubmitting supplementary materials after the clinical trial application was rejected last month. With this approval, OliX has completed the ethics committee procedures required to conduct clinical trials in New Zealand.
In New Zealand, conducting a clinical trial requires separate approvals from both the ethics committee (HDEC) and the pharmaceutical regulatory authority, the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). OliX completed its submission of the clinical trial protocol approval application to Medsafe on September 30. It is currently awaiting the review results.
Last month, OliX publicly disclosed that its Phase 2a clinical trial protocol application for OLX301A in New Zealand had been rejected, sparking concerns from some quarters. The company expects this New Zealand HDEC approval to provide momentum for the global clinical trials of OLX301A.
An OliX official stated, "We are continuing preparations so that we can promptly initiate the first dosing in this clinical trial, which targets patients with age-related macular degeneration accompanied by Geographic Atrophy (GA)."
in THEBIO