The FDA has placed a clinical hold on Adverum Biotechnologies’ investigational new drug application for its gene therapy candidate for wet age-related macular degeneration until it receives further information regarding the company’s manufacturing process, according to a press release.
The company completed enrollment and dosing in the first cohort of the phase 1 OPTIC trial of ADVM-022, a single administration gene therapy; however, the FDA requested additional chemistry, manufacturing and controls information and requirements regarding the manufacturing process of ADVM-022, the release said.
Adverum has submitted a response and is working with the FDA during the review.
“We are working with the FDA to resolve this matter as quickly as possible,” Adverum CEO Leone Patterson said in the release. “We are deeply committed to the development of our novel gene therapy ADVM-022 for patients with wet AMD. In the OPTIC trial, the [data monitoring committee] reviewed the safety data and unanimously agreed that we could proceed to dosing the second cohort. No patient has experienced [a serious adverse event], with a follow-up period of up to 5 months. We look forward to sharing 24-week primary and secondary outcomes from the first cohort of patients at a scientific meeting in the second half of this year.”