LogicBio Therapeutics Shares Skyrocket As FDA Lifts Clinical Hold On Its Pediatric Trial

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  • The FDA has lifted the clinical hold on LogicBio Therapeutics Inc's 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.
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