Recently, Bayer (BAYRY.US) and its wholly-owned independent operating subsidiary Asklepios BioPharmaceuticals (AskBio) announced that the US FDA has granted the AB-1002 project fast-track qualification.
The Zhitong Finance App learned that recently, Bayer (BAYRY.US) and its wholly-owned independent operating subsidiary Asklepios BioPharmaceuticals (ASKBio) announced that the US FDA has granted the AB-1002 project fast-track qualification. AB-1002 is a single-dose gene therapy under development. It acts on the heart to promote the production of a constitutive active form of protein inhibitor 1 (I-1c) and block the effects of protein phosphatase 1. Inhibiting the function of this protein associated with congestive heart failure (CHF) may have therapeutic effects.
According to reports, patients are currently being recruited for the GenePHIT (gene phosphatase inhibitory therapy) clinical phase 2 trial. GeneFit is a phase 2 adaptive, double-blind, placebo-controlled, randomized, multicenter trial to evaluate the safety and efficacy of a single dose of AB-1002 in male and female patients 18 years of age and older with non-ischemic cardiomyopathy with symptoms of New York Heart Association (NYHA) grade III heart failure. Subjects were randomly divided into low dose, high dose, or placebo treatment groups in a 1:1 manner. Key outcome measures include cardiovascular death and changes in NYHA ratings relative to baseline, left ventricular ejection fraction (LVEF), maximum oxygen consumption (PvO2), and 6-minute walk test (6MWT).