Swedish start-up Atrogi has enrolled the first patient in its Phase Ia/b study of ATR-258, a novel b2adrenoceptor agonist for the treatment of type 2 diabetes and comorbidities.
Conducted in Mannheim, Germany by Clinical Research Services (CRS), the trial is expected to be completed by April 2023 with the final report in June 2023.
The Phase I protocol covers three parts, Part A: Single Ascending Dose of the drug candidate given to healthy volunteers, and Part B: Multiple Ascending Dose administered to healthy volunteers.
Both parts A and B have been completed successfully involving 48 healthy volunteers. Preliminary blinded data from the healthy volunteers suggests that ATR-258 was well tolerated without severe adverse reactions.
Now the final part of the study with type 2 diabetes patients has commenced: in Part C: daily administration of ATR-258 at a fixed dose during 28 days in 24 type 2 diabetic patients.
“There is a large unmet need for durable and efficient treatments for type 2 diabetes patients,” said Alexandra Ekman Ryding, CEO. “We believe that our first-in-class drug candidate ATR-258 with its unique mode of action, has the potential to not only help these patients manage their blood glucose levels, but also help treat the actual cause of the disease. As of yet, no other type 2 diabetes drug has managed to achieve this.”