02.02.2022 12:14:38
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LogicBio Therapeutics' Phase 1/2 SUNRISE Trial Of LB-001 Placed On Clinical Hold
(RTTNews) - LogicBio Therapeutics, Inc. (LOGC) said FDA has notified the company that its phase 1/2 SUNRISE trial of LB-001 in pediatric patients with methylmalonic acidemia has been placed on clinical hold. The company noted that, until it 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.
In January 2022, the fourth patient dosed in the SUNRISE trial experienced a drug-related serious adverse event, which was categorized as a case of thrombotic microangiopathy. As a result, the FDA notified the company that the SUNRISE trial has been placed on clinical hold.
LogicBio said it will be working closely with the FDA and the Data Safety Monitoring Board for the trial to determine the next steps for the SUNRISE trial and the LB-001 program.
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