Early-stage biopharma company Atrogi has received approval from the Federal Institute for Drugs and Medical Devices (BfArM) in Germany to initiate a Phase I study for its drug candidate targeting type 2 diabetes.
The approval means that Atrogi will be able to launch a Phase I study for its small molecule drug candidate ATR-258 in healthy volunteers and type 2 diabetics.
Atrogi is expecting to complete the trial by the end of 2022 with final results available in the first half of 2023.
Based on research into adrenergic signaling by professor Tore Bengtsson at Stockholm University, ATR-258 is a small molecule therapy that works by selectively stimulating b2-adrenergic receptors to translocate GLUT4 to the cell membrane.
This promotes glucose uptake in skeletal muscle resulting in a reduction of blood glucose levels achieved without insulin. Atrogi believes ATR-258 has the potential to produce a frontline treatment for type 2 diabetes that produces minimal side effects.
The Phase I protocol will cover three parts which will assess the safety, efficacy and correct dosage of ATR-258.
The first part will see a single ascending dose of the drug candidate given to healthy volunteers. The second will see a multiple ascending dose administered to healthy volunteers. Lasty, the final stage will see the continuous administration of the drug given at a fixed dose during 28 days in patients with type 2 diabetes. Eligible patients for the trial should have a HbA1c level of 7-9% after a Metformin wash-out period over four weeks.
Alexandra Ekman Ryding, CEO of Atrogi said: “Following extensive pre-clinical work, the first study in man is an important milestone for our company and we are thrilled to initiate the study together with our CRO partner German-based Clinical Research services specialising in early clinical trials. ATR-258 offers a real alternative to insulin by focusing on fully functioning systems in the body, rather than trying to make dysfunctional signalling systems work. It’s an entirely new class of oral type 2 diabetes drugs.”