Selecta Biosciences said that the US Food and Drug Administration (FDA) has imposed a clinical hold on its phase 1/2 clinical trial of SEL-302 gene therapy for the treatment of methylmalonic acidemia (MMA).

SEL-302 consists of MMA-101 plus ImmTOR immune tolerance platform.

The US-based biotech company said that it has been sent a letter from the FDA regarding the clinical hold with an objective to get further details on the chemistry, manufacturing and controls (CMC) associated with the MMA-101 product candidate.

According to Selecta Biosciences, the FDA letter does not have any outstanding clinical or pre-clinical questions.

The early-stage clinical trial in methylmalonic acidemia is yet to be initiated, and no patients will be dosed with MMA-101 unless all of the questions from the FDA are resolved, said Selecta Biosciences.

Carsten Brunn — president and CEO of Selecta Biosciences, commenting on the SEL-302 phase 1/2 trial in methylmalonic acidemia, said: “Patient safety is our primary concern, and we are committed to addressing the FDA’s questions regarding CMC as expeditiously as possible.

“We look forward to working closely with the FDA to satisfy all outstanding concerns, and to providing additional updates early next year.”

  Carsten Brunn, gene therapy, ImmTOR, methylmalonic acidemia, MMA-101, SEL-302, Selecta Biosciences, US FDA, US Food and Drug Administration, USA