Logic B o Phase 1/2 Trial Put on Hold

 LogicBio Therapeutics, Inc. (Nasdaq: LOGC), a clinical-stage genetic medicine company, today provided an update on the LB-001 clinical development program. The U.S. Food and Drug Administration (FDA) has notified the company that its Phase 1/2 SUNRISE clinical trial of LB-001 in pediatric patients with methylmalonic acidemia (MMA) has been placed on clinical hold. The company will host a conference call and webcast this morning to discuss this update.

To date, four patients have been dosed in the SUNRISE trial with LB-001, LogicBio's investigational, single-administration, adeno-associated virus (AAV) genome editing therapy. In accordance with the FDA-cleared protocol, the first two patients dosed were in the older age group (3 to 12 years old) and received 5 x 1013 vg/kg of LB-001. These first two patients are doing well, have not experienced drug-related serious adverse events (SAEs), and are being monitored in accordance with the protocol.

As previously disclosed, the third patient dosed in the SUNRISE trial, who received 5 x 1013 vg/kg of LB-001 and is in the younger age group (6 months to 2 years old), experienced a drug-related SAE, which was categorized as a case of thrombotic microangiopathy (TMA). TMA has been previously reported in association with other AAV genetic therapies. The patient was hospitalized and responded well to intravenous fluids and parenteral nutrition. Following this SAE, the company implemented additional safety measures in the SUNRISE trial, and reported the SAE to the FDA and the Data Safety Monitoring Board for the trial (DSMB). In December 2021, the company announced that the SAE experienced by the third patient had resolved.

In January 2022, the fourth patient dosed in the SUNRISE trial, who received 5 x 1013 vg/kg of LB-001 and is in the younger age group, experienced a drug-related SAE, which was categorized as a case of TMA. The patient is being closely followed by the patient's care team and has been steadily improving. The company reported the SAE to the FDA and the DSMB. The FDA subsequently notified the company that the SUNRISE trial has been placed on clinical hold. LogicBio will be working closely with the FDA and the DSMB to determine the next steps for the SUNRISE trial and the LB-001 program.

Conference Call and Webcast Details

LogicBio will host a conference call and webcast today, Wednesday, February 2, 2022, at 8:30 a.m. ET to discuss the program update. To listen to the conference call, please dial +1 (833) 519-1335 (domestic) or +1 (602) 585-9978 (international) using conference ID number 7545016. A live webcast of the call can be accessed via the Investors section of the company's website at https://investor.logicbio.com. A webcast replay will be available following the call and archived for approximately 30 days.

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