Atrogi AB, an early-stage Swedish pharma company, has announced that the first patient has been enrolled in a phase 1a/b study.
Atrogi’s drug candidate, ATR-258 is a first in class novel b2 adrenoceptor agonist with a unique mechanism of action for the treatment of type 2 diabetes and comorbidities. This approach is supported by data presented in a January 2023 clinical publication in Nature Communications. The trial is expected to be completed by April 2023 with the final report in June 2023.
Conducted in Mannheim, Germany, by Clinical Research Services (CRS), the phase 1a/b study is a double-blind, placebo-controlled, randomized study evaluating the safety of ATR-258 for the treatment of type 2 diabetes.
Atrogi’s drug candidate study details
The study protocol covers three parts. Part A is a single ascending dose of the drug candidate given to healthy volunteers, while Part B is a multiple ascending dose administered to healthy volunteers. Both parts A and B have been completed with 48 healthy volunteers.
Preliminary blinded data from the healthy volunteers suggests that ATR-258 was well tolerated without severe adverse reactions. The final part of the study with type 2 diabetes patients has started. In Part C, there will be a daily administration of ATR-258 at a fixed dose for 28 days in 24 type 2 diabetic patients.
”There is a large unmet need for durable and efficient treatments for type 2 diabetes patients. 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,” said Alexandra Ekman Ryding, Atrogi CEO.