FDA lifts a clinical hold on Selecta gene therapy after another delay hampers R&D plans
Three months after Selecta BioSciences got word that the FDA had slapped a clinical hold on its Phase I/II study of methylmalonic acidemia drug SEL-302 to clear up some CMC issues, the biotech says they are back in business.
“I am pleased to announce that on March 9th the FDA lifted the clinical hold on our SEL-302 gene therapy program to treat methylmalonic acidemia. We look forward to starting our phase 1 clinical trial expeditiously and to bring hope to those patients and families seeking a potentially durable and lifelong treatment for this terrible disease,” said Selecta CEO Carsten Brunn in a prepared statement.
Back in November Brunn emphasized that regulators had not raised any clinical issues around the gene therapy, which leads that segment of the pipeline. The disease prevents children from metabolizing amino acids, triggering dangerous toxicity.
Asklepios had been partnered on this program until the spring of last year when it handed back full rights to Selecta. At the time, the biotech flagged a delay on its IND due to “a manufacturing issue we believe is related to a component sourced from a third-party.”
Selecta has been roughed up badly by the shellacking being handed out to biotech companies. Its stock has shed 55% of its value in the past year. And it’s not the only gene therapy player to feel the regulatory heat in the past year, as a fresh crop of safety fears has afflicted a large group of biotechs.