Epirium Bio Inc. has obtained IND clearance from the FDA for MF-300, a first-in-class orally administered, 15-hydroxyprostaglandin dehydrogenase (15-PGDH) enzyme inhibitor.
Arbor Biotechnologies Inc. has gained IND clearance from the FDA for ABO-101, a novel gene editing therapeutic designed to address primary hyperoxaluria type 1 (PH1). A phase I/II study in adult and pediatric patients with PH1 is expected to begin in the first half of 2025.
Vigeneron GmbH has received IND approval from the FDA for VG-801, a novel mRNA trans-splicing gene therapy to treat Stargardt disease and other retinal dystrophies associated with mutations in the ABCA4 gene. IND clearance enables initiation of a phase I/II trial, with a clinical trial application (CTA) submission to the EMA also planned in the coming months.
