Atrogi Announces Positive Clinical Data from First-in-Class Insulin-Independent Treatment for Type 2 Diabetes

All endpoints met for novel b2adrenoceptor agonist ATR-258 treating root cause of T2D

Solna, Sweden 14 March 2024 – Atrogi, a pioneering clinical-stage biotech company advancing treatments for metabolic disorders, announces the full set of results from its Phase 1 a/b trial with ATR-258, its first-in-class treatment for type 2 diabetes (T2D). This clinical trial, conducted on both healthy volunteers and individuals with T2D, underscores the safety of ATR-258 as a novel b2-adrenoceptor agonist, offering a revolutionary approach to type 2 diabetes treatment.

The unique mechanism of action of ATR-258 enables the selective modulation of specific positive intracellular signaling pathways. This innovative approach makes it possible to address the core issue of type 2 diabetes, effectively reversing it to healthy levels as demonstrated in preclinical studies.

Atrogi’s CEO, Alexandra Ekman Ryding, said, “This full phase 1a/b data readout is exactly what we were aiming for, with primary and secondary safety endpoints met. This puts us in a strong position to progress our ground-breaking small molecule compound ATR-258 into a larger multi-centre Phase II trial later this year, underpinned with an upcoming Series B financing. We strongly believe that our novel approach could become a transformative treatment for T2D patients.”

Atrogi´s founder and CSO, Professor Tore Bengtsson, said,“These safety results strongly validate my long-held vision for a more holistic treatment for diabetes that not only treats the underlying cause but also supports overall health and quality of life.  It underscores the therapeutic value of this novel pathway for the treatment of type 2 diabetes. Notably, in the final cohort of people with T2D we had been specifically looking for cardiovascular safety, which is now confirmed.”

Atrogi’s board chair, Anders Ekblom, said, “Diabetes and obesity are major global health challenges. Better treatments are needed that improve glycaemic control while maintaining muscle mass, the latter decreasing more prominently in aging and diabetic populations. Atrogi’s unique discovery of receptor signalling, which treats the root cause of the disease via an insulin independent pathway, has the potential to create unique treatment opportunities and even disrupt the current diabetes market.”

The ‘ATTRACTIVE 1’ trial (1), conducted in Mannheim, Germany, by Clinical Research Services (CRS), was a double-blind, placebo-controlled, randomized trial evaluating the safety of ATR-258 for the treatment of T2D. The complete trial investigated the use of single, and multiple, ascending doses of ATR-258 in 46 healthy volunteers as well as its administration at a fixed dose in 23 T2D patients over 28 days. The final data demonstrated that ATR-258 was safe and well tolerated in healthy volunteers, and, importantly, also in the T2D patients.

References

1. ClinicalTrials.gov identifier: NCT05409924