The FDA has completed the review of Moderna’s (NASDAQ:MRNA) IND application for mRNA-3927, its investigational mRNA therapeutic for propionic acidemia (PA) and allowed it to proceed to clinic.
Moderna plans to initiate an open-label Phase 1/2 study of multiple ascending doses of mRNA-3927 in primarily pediatric patients with PA in U.S. and Europe. The objectives of this study are to evaluate the safety and tolerability of mRNA-3927 administered via IV infusion, characterize the pharmacokinetic profile of mRNA-3927 and assess the pharmacodynamic response as assessed by changes in plasma biomarkers.
This is the second rare disease candidate from Moderna’s pipeline with an open IND.
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