Selecta's Gene Therapy Trial For Genetic Metabolic Disorder Put On FDA Hold

The FDA has placed a clinical hold on Selecta Biosciences Inc's SELB Phase 1/2 trial of SEL-302 (which consists of MMA-101 plus ImmTOR) for methylmalonic acidemia (MMA).

• MMA is a disorder in which the body cannot break down certain proteins and fats, resulting in a buildup of methylmalonic acid in the blood.
• The condition may lead to metabolic acidosis, hyperammonemia, and long-term complications.
• Also Read: Selecta Biosciences Stock Is Trading Lower After Gaining Total Rights To MMA Program From AskBio.
• On November 23, Selecta received a letter from the FDA to obtain additional information on the chemistry, manufacturing, and controls (CMC) related to the MMA-101. 
• There were no outstanding clinical or pre-clinical questions in the FDA letter.
• The clinical trial had not yet been initiated, and no human patients will be dosed with MMA-101 until all of the FDA's questions are resolved. 
• Related Link: Selecta Biosciences Posts Encouraging Data For ImmTOR Platform.
• Price Action: SELB shares are down 13.5% at $2.75 during the premarket session on the last check Friday.