- The FDA has lifted the clinical hold on LogicBio Therapeutics Inc's (NASDAQ:LOGC) LB-001 Investigational New Drug Application (IND) to resume patient enrollment in Phase 1/2 SUNRISE trial in pediatric methylmalonic acidemia patients.
- Methylmalonic acidemia is an inherited disorder in which the body cannot process certain proteins and fats (lipids) properly.
- The FDA acknowledged that the company satisfactorily addressed all clinical hold issues in its letter.
- The company plans to start dosing in Q3 2022.
- Related: Why Did LogicBio Therapeutics Shares Plunge To 52-Week Low Today?
- In connection with the lifting of the clinical hold, LogicBio amended the SUNRISE protocol to reflect its dialogue with the FDA.
- LogicBio expects to proceed with dosing after implementing the changes to the SUNRISE protocol, which include enhanced monitoring measures and the use of a complement inhibitor if there are laboratory findings indicating a potential TMA.
- LogicBio plans to treat the next patients, who may be as young as six months old, at the 5e13 vg/kg dose and continually assess safety outcomes.
- Outlook: LogicBio is reinstating its previous guidance and expects to present interim clinical data from the SUNRISE trial by the end of Q2 of 2022.
- Price Action: LOGC shares are up 64.7% at $0.82 during the premarket session on the last check Monday.
