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Atrogi receives regulatory approval from German health authority

Alexandra Ekman Ryding

Atrogi has received approval from the German authority BfArM to initiate a phase 1 study with their small molecule drug candidate ATR-258 in healthy volunteers and type 2 diabetics.

The trial is expected to be completed by year end 2022 with the final report in Q1/2,2023.

“Following extensive pre-clinical work, the first study in humans 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 specializing in early clinical trials. ATR-258 is a completely new class of drug for the treatment of T2D and through its unique MoA, it not only leads to positive effects on the glucose levels, but it also alleviates the insulin signaling system, actually restoring it. To our knowledge, no other today marketed T2D drug has the ability to lower glucose levels, treat some of the most common comorbidities among T2D patients, and mend the dysfunctional insulin signaling pathway. ATR-258 is truly unique,” says Alexandra Ekman Ryding, CEO of Atrogi.

ATR-258

ATR-258 is based on ground-breaking research into adrenergic signaling by Professor Tore Bengtsson at Stockholm University leading to the discovery of how to selectively stimulate b2-adrenergic receptors to promote glucose uptake in skeletal muscle resulting in a reduction of blood glucose levels, achieved independently of insulin.  Atrogi believes ATR-258 has great potential as a treatment for type 2 diabetes, normalizing glucose homeostasis as well as combating common comorbidities, actually restoring normal physiological functions.

The Phase I protocol covers three parts, Part A: Single Ascending Dose of the drug candidate given to healthy volunteers, Part B: Multiple Ascending Dose administered to healthy volunteers and Part C: continuous administration of ATR-258 at a fixed dose during 28 days in patients with type 2 diabetes. Eligible Diabetes patients should have a HbA1c level of 7-9% after a Metformin wash-out period over 4 weeks.

Photo of Alexandra Ekman Ryding