LEVERKUSEN (dpa-AFX) - Bayer AG (BAYRY) announced on Thursday that its subsidiary, Asklepios BioPharmaceutical, Inc., also known as AskBio, has received Fast Track Designation from the FDA for the AB-1002 also known as NAN-101 program, aimed at treating patients with advanced congestive heart failure or CHF.
AskBio is currently recruiting participants for the Phase II Gene PHosphatase Inhibition Therapy or GenePHIT trial of AB-1002 intended for treating CHF.
The primary goal of the Phase II adaptive trial of GenePHIT is to evaluate the safety and efficacy of AB-1002 through a single administration using antegrade intracoronary artery infusion in male and female individuals aged over 18 with non-ischemic cardiomyopathy and New York Heart Association Class III heart failure symptoms.
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