Company states that "some supplemental data required" for the clinical trial submission.
Application for Australian Phase 2a trial filed in September; follow-up procedures to proceed as originally planned.
OliX (226950) announced that its application for a Phase 2a clinical trial of its macular degeneration therapeutic program, "OLX301A" (generic name OLX10212), has been rejected by the local ethics committee in New Zealand. The company explained that the decision stems from the need to supplement parts of the submitted documentation and stated that it plans to pursue follow-up procedures, including a resubmission, once the requirements are met.
In a regulatory filing on the 12th, OliX notified the public that the Northern B Health and Disability Ethics Committee (HDEC) of New Zealand had rejected the application. The committee determined that the submission did not meet local ethical standards and relevant regulatory requirements.
In a separate statement, the company clarified that the rejection was due to the local review body's opinion that certain submitted data required supplementation. OliX intends to conduct a thorough review of the cited issues and promptly proceed with the necessary updates to facilitate a resubmission. The company confirmed in its regulatory disclosure that it is currently preparing for a re-examination and subsequent filing.
Previously, OliX had announced in a corrected filing on the 30th of last month that it had submitted an application for Phase 2a clinical trial approval for OLX10212 to the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). The institution that issued this rejection is the Northern B ethics committee.
Alongside the rectification process for the New Zealand application, the company is also pushing forward with its Australian clinical trials. OliX noted that it completed its application for the Phase 2a clinical trial in Australia in September and will continue with subsequent procedures in accordance with its original development plan.
The clinical trial is designed to evaluate the efficacy and safety of OLX10212 in patients with age-related macular degeneration (AMD) accompanied by geographic atrophy (GA) in both eyes. The study, conducted across multiple clinical centers, will involve the random assignment of patients into either a drug-treated group or a sham-procedure control group, with the experimental group receiving intravitreal injections of the drug.
