Betagenon /Balticgruppen Bio AB announces the start of a bridging PK and safety clinical trial of a novel solid pharmaceutical composition of AMPK activator compound O304 [17-August-2020] STOCKHOLM , Aug. 17, 2020 /PRNewswire/ -- In previous Phase I and Phase IIa clinical trials in healthy subjects and in type 2 diabetics, the small molecule AMPK activator compound O3
STOCKHOLM, Aug. 17, 2020 /PRNewswire/ -- In previous Phase I and Phase IIa clinical trials in healthy subjects and in type 2 diabetics, the small molecule AMPK activator compound O304 was administered as a suspension and with limited oral bioavailability. A novel formulation of O304 has now been developed that unexpectedly improved oral bioavailability markedly in animals. A patent application (matter of composition) with priority date to 2039 without extensions has been submitted. Approvals from the Medicine Product Agency, Sweden, and the Ethics committee to conduct the clinical study have recently been granted. Thomas Edlund, CEO of Betagenon AB; “An open, randomised, parallel-group study evaluating the exposure of and safety of O304 Na-salt after single and multiple dosing and in combination with dapagliflozin (Forxiga) at steady state in healthy volunteers has now been initiated.” About AMP Activated Protein Kinase (AMPK) About O304 In Phase I and Phase IIa clinical trials O304 showed good safety/tolerability with the expected pharmacokinetics. Moreover, the beneficial metabolic, micro- and macro-circulatory effects observed in animals successfully translated into findings in man. The available data support efficacy of O304 in obesity, diabetes, heart failure and chronic kidney disease. Betagenon/ Balticgruppen Bio AB is a privately owned Swedish Biotechnology company. Betagenon has received funding from EU’s research and innovation framework program Horizon 2020 (EU project 754268 - AMPK-DIAB). Contact: This information was brought to you by Cision http://news.cision.com The following files are available for download:
SOURCE Betagenon AB |