The FDA has placed a clinical hold on LogicBio Therapeutics Inc's (NASDAQ:LOGC) Phase 1/2 SUNRISE trial of LB-001 in pediatric patients with methylmalonic acidemia (MMA).
- The hold follows after two adolescent patients in the trial were diagnosed with thrombotic microangiopathy (TMA), a clinical syndrome defined by the formation of tiny clots in blood vessels.
- The Company is evaluating LB-001 in a Phase 1/2 trial to treat children with the rare metabolic disease methylmalonic acidemia, which results in patients not breaking down certain fats and proteins.
- In that study, two of four patients reported cases of TMA, neither of which proved fatal.
- In the first case, LogicBio instituted new safety protocols in the SUNRISE trial following the patient's diagnosis. That case was resolved as of December 2021.
- In the second case, the patient was diagnosed with TMA in January of this year and is currently being monitored.
- Until the Company has more clarity regarding the impact of the clinical hold, LogicBio is suspending guidance on the timing of announcing interim data for the SUNRISE trial. Earlier it expected data in Q2 of FY22.
- Price Action: LOGC shares are down 55% at $0.67 during the market session on the last check Wednesday.
