OliX Pharmaceuticals (226950.KQ) said its application for a Phase 2a clinical trial in New Zealand of OLX10212, a candidate treatment for age-related macular degeneration, was rejected by a local ethics committee for failing to meet national ethical standards and relevant laws. The company plans to address the findings and pursue a review and resubmission.
OliX said in a regulatory filing on the 12th that its Phase 2a trial protocol application for OLX10212 had been turned down by New Zealand's Northern B Health and Disability Ethics Committee (HDEC).
The trial was designed to evaluate the efficacy and safety of OLX10212 in patients with age-related macular degeneration (AMD) accompanied by bilateral geographic atrophy (GA). The drug was to be administered by intravitreal injection in a multicenter, randomized, sham-controlled study.
According to the filing, the HDEC concluded that the trial application did not meet New Zealand's ethical standards and relevant laws. The committee did not disclose which specific requirements were not met.
The rejection stems from a failure to meet ethical and legal requirements during the application process. The filing presented no separate assessment of the candidate's efficacy or safety.
An OliX official said the company is closely reviewing the issues raised by the HDEC and preparing for a review and resubmission, adding that it will move quickly on the related procedures.