“We have determined that the rejection does not stem from fundamental issues with the clinical study design.”
Company expects a two-month approval window in Australia; plans for parallel filings in the U.S. and South Korea are underway.
OliX (226950) is moving to resubmit its Phase 2a clinical trial application for "OLX301A," a therapeutic candidate for macular degeneration, in New Zealand this month following a recent rejection. Following the public disclosure of the rejection, the company clarified its plans to supplement the necessary documentation and outlined its clinical development strategy across different regions.
In a letter to shareholders on the 13th, OliX explained that it has thoroughly reviewed the reasons for the rejection and is preparing a revised submission for October. The company stated, "We have determined that this matter does not result from any fundamental problems with the clinical trial protocol design itself."
Previously, on the 12th, OliX disclosed that the Northern B Health and Disability Ethics Committee (HDEC) in New Zealand had rejected the clinical trial application. According to the disclosure, the committee determined that the application failed to meet local ethical standards and relevant regulatory requirements.
In its update, the company clarified that conducting clinical trials in New Zealand requires both regulatory approval from Medsafe, the nation’s pharmaceutical regulator, and ethical approval from the HDEC. It emphasized that the rejection notice originated from the HDEC, not Medsafe.
OliX noted that it would leverage its prior experience in successfully obtaining Medsafe approval for the Phase 2a trial of its androgenetic alopecia treatment, OLX104C, to expedite the follow-up process.
Regarding the Phase 2a clinical trial in Australia, the application was submitted on September 16. The company stated that past approvals in Australia typically took between one month and two and a half months, and it anticipates a similar timeline of approximately two months for the current application. However, it added that the actual approval date may vary depending on local procedures and progress.
OliX also plans to accelerate clinical trial submissions in the United States and South Korea. The company aims to ensure that the global development timeline for the Phase 2a trial remains on track by preparing the New Zealand resubmission in parallel with clinical preparations in other jurisdictions.
The Phase 2a trial for the OLX301A program is designed to evaluate the safety and efficacy of the candidate substance, OLX10212, via intravitreal injection in patients with age-related macular degeneration (AMD) accompanied by geographic atrophy (GA) in both eyes.
