ABF-101, an oral macular degeneration treatment under development by Aptabio, received a hold notice from the U.S. Food and Drug Administration (FDA) during its phase 1 clinical trial.
According to Aptabio on the 24th, the company received the FDA's clinical hold notification email through its contract research organization (CRO) on the 21st.
Aptabio had been conducting single- and multiple-ascending dose studies in the United States to evaluate the safety, tolerability, and pharmacokinetics of oral ABF-101. The subjects were healthy adults and patients with age-related macular degeneration (AMD).
The FDA was said to have requested supplementation of certain nonclinical data. The measure followed the discovery of internal operational issues during an on-site inspection of a Japan-based nonclinical contract testing organization by the Pharmaceuticals and Medical Devices Agency (PMDA) under Japan's Ministry of Health, Labour and Welfare.
The company said, "The FDA recommended placing on hold or suspending the related clinical trial until the completeness and reliability of the genotoxicity test data conducted by the institution are reconfirmed," adding, "Accordingly, we have temporarily suspended the ongoing trial and immediately started supplementing the relevant nonclinical data."
The company plans to resume the trial immediately upon receiving restart approval from the FDA after submitting the supplementary data.