BRIEF—FDA lifts clinical hold on Selecta gene therapy

The US Food and Drug Administration (FDA) has removed the clinical hold on Selecta Biosciences’ SEL-302 gene therapy program to treat methylmalonic acidemia.

Selecta, a US biotech company, was forced by the FDA to pause the program in November 2021 due to issues relating to chemistry, manufacturing and controls, though the agency is now satisfied that the research can continue.

Carsten Brunn, president and chief executive of Selecta, who announced the news while presenting the company’s latest financial results, said: “We look forward to starting our Phase I clinical trial expeditiously and to bring hope to those patients and families seeking a potentially durable and lifelong treatment for this terrible disease.”