[Edaily Reporter Na Eun-kyung] #Aptabio announced on the 16th that it has received notification from the U.S. Food and Drug Administration (FDA) lifting the clinical hold on its U.S. Phase 1 clinical trial for ABF-101, an oral treatment for age-related macular degeneration, and will resume the trial.

Previously, in February, the FDA had placed a clinical hold on the ABF-101 Phase 1 trial. According to the company, this was not due to issues with the drug’s mechanism of action or safety, but rather resulted from administrative and procedural issues related to non-clinical data from a Japan-based contract research organization (CRO).

Aptabio subsequently submitted supplementary data and conducted additional tests, and the clinical hold was lifted after the FDA determined that the relevant requirements had been met. The company plans to resume the U.S. Phase 1 clinical trial and continue with subsequent development.

ABF-101 is an oral candidate drug for age-related macular degeneration (AMD) currently under development by Aptabio. Since intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections are currently the standard of care for AMD, there is growing interest in the development of an oral treatment.

An Aptabio official stated, “We will accelerate the development of ‘ABF-101’ following the resumption of clinical trials,” adding, “As transactions related to age-related macular degeneration have recently become active in the global market, we plan to secure differentiated clinical data.”

Aptabio has completed patient dosing for the global Phase 2 clinical trial of “Isuzinacxib” (APX-115), a treatment for contrast-induced acute kidney injury, and is set to announce key results (topline data) in the second half of the year. The immunotherapy APX-343A is currently undergoing a combination clinical trial with Merck (MSD) USA’s blockbuster immunotherapy Keytruda.

The company plans to participate in “Bio USA 2026,” taking place in San Diego, U.S., starting on the 22nd, to discuss business development and partnerships with global pharmaceutical companies.