Olix Pharmaceuticals, Inc. announced on the 30th that it had received approval from the Bellberry Human Research Ethics Committee (Bellberry HREC) for the Australian Phase 2a clinical trial protocol of its age-related macular degeneration (AMD) treatment candidate “OLX301A” (chemical name OLX10212).
This clinical trial will evaluate the efficacy and safety of OLX301A in 64 patients with age-related macular degeneration (AMD) complicated by geographic atrophy (GA). It will be conducted as a multicenter, randomized, sham-controlled trial, with the primary endpoint being the progression of damage in the epiretinal zone (EZ)—which reflects the condition of retinal photoreceptors—at 24 weeks post-administration.
The EZ is a structural indicator that reflects the condition of retinal photoreceptors, which are closely linked to visual function. Since damage to the EZ can occur before the expansion of GA lesions or vision loss, it allows for the assessment of photoreceptor damage at an earlier stage—damage that is difficult to detect based solely on changes in the area of existing GA lesions.
OLX301A is a therapeutic candidate currently under development based on “OASIS-Eye,” a platform within Olix Pharmaceuticals, Inc.’s proprietary RNA interference technology platform, OASIS, that is specialized for ophthalmic diseases. In a previously conducted U.S. Phase 1 clinical trial, the safety and tolerability of both single and repeated doses were confirmed. Early signs of efficacy, such as improvements in best-corrected visual acuity (BCVA), were also observed in some patients.
Based on this approval, Olix Pharmaceuticals, Inc. plans to proceed with follow-up procedures to initiate local clinical trials in Australia. The company also plans to pursue multinational clinical trials to enhance the efficiency of patient recruitment and clinical operations.
Lee Dong-ki, CEO of Olix Pharmaceuticals, Inc., stated, “This approval for the Phase 2a clinical trial in Australia marks a significant step forward in fully validating the therapeutic efficacy of OLX301A,” he said. “While currently approved GA treatments are effective at slowing the progression of the disease, they have not demonstrated substantial improvements in visual acuity. Furthermore, some treatments raise safety concerns, such as an increased risk of choroidal neovascularization (CNV), leaving a significant unmet medical need.”
He added, “Through this clinical trial, we will focus on demonstrating the clinical value of OLX301A while also accelerating discussions on technology transfer with potential global partners.”
