“We believe it is not a fundamental problem with the clinical design itself.”
Approval in Australia is expected to take approximately 2 months... Applications from the US and Korea are also promoted.
Olix (226950) is seeking to resubmit this month in response to the rejection of the New Zealand phase 2a clinical trial plan application for ‘OLX301A’, a macular degeneration treatment development program. Following the announcement of the rejection the day before, the supplementary data and clinical implementation plans for each country were specifically announced.
Olix explained in a shareholder notice on the 13th that it plans to closely review the reasons for rejection, supplement the necessary data, and push for resubmission in October. The company said, “We believe that this issue is not due to a fundamental problem with the clinical trial protocol design itself.”
Previously, Olix announced on the 12th that New Zealand's Northern B Health and Disability Ethics Committee (HDEC) had rejected the clinical trial application. According to the announcement, the committee determined that the application did not meet local ethical standards and relevant laws.
In this notice, the company explained that in order to conduct clinical trials in New Zealand, it must obtain regulatory approval from Medsafe, the pharmaceutical regulator, and ethics approval from HDEC. It was also emphasized that the agency that notified this rejection was HDEC, not Medsafe.
Olix announced that it would quickly respond to follow-up procedures based on its experience in obtaining Medsafe approval for the New Zealand phase 2a clinical trial plan for OLX104C, a treatment for male pattern hair loss.
The Australian phase 2a clinical trial completed the application for trial plan approval on September 16. The company explained that in the past it took about one to two and a half months to get clinical approval in Australia, and that it expects the approval period to be about two months this time as well. However, he added that the actual approval timing may vary depending on local procedures and progress.
We plan to expedite the submission of clinical trial plans in the United States and Korea as well. The company plans to ensure that there are no disruptions to the overall development schedule for the global phase 2a clinical trial by simultaneously preparing for New Zealand's resubmission and clinical preparations in other countries.
The phase 2a clinical trial of the OLX301A program is designed to evaluate the efficacy and safety of the candidate OLX10212 by injecting it into the vitreous cavity of the eye in patients with age-related macular degeneration (AMD) with geographic atrophy (GA) in both eyes.
