Aro Biotherapeutics Announces U.S. FDA Clearance of IND Application for ABX1100 for Potential Treatment of LOPD

Aro Biotherapeutics Announces U.S. FDA Clearance of IND Application for ABX1100 for Potential Treatment of LOPD

Posted On: 07/02/2025

Announcement coincides with WORLDSymposium™ presentation highlighting knockdown of GYS1 mRNA and protein in muscle, as well as favorable safety and tolerability profile, in normal healthy volunteers

Aro Biotherapeutics a clinical-stage biotechnology company working to develop potent and tissue-targeted medicines, announced that it has received U.S. Food and Drug Administration (FDA) clearance of the Investigational New Drug Application (IND) for ABX1100, a novel therapy currently being investigated in a phase 1 study in late-onset Pompe disease (LOPD) patients.

Aro presented data at the 2025 WORLDSymposium™ in San Diego, California, from a phase 1 study in normal healthy volunteers (NHVs) in which ABX1100 provided durable knockdown of glycogen synthase 1 (GYS1) messenger RNA (mRNA) and protein in the muscle. ABX1100 also was well-tolerated and exhibited predictable pharmacokinetics (PK) in the Phase 1 trial in NHVs.

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https://finance.yahoo.com/news/aro-biotherapeutics-announces-u-fda-133700556.html