Atrogi 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.
All endpoints met for novel β₂-adrenoceptor agonist ATR-258 treating root cause of T2D
SOLNA, Sweden, March 14, 2024 (GLOBE NEWSWIRE) -- 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 β2-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’ trial1, 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
Notes to Editors
About Atrogi
Atrogi is a clinical-stage biotech company, developing first-in-class, insulin-independent treatments for type 2 diabetes and related metabolic disorders, including obesity and muscle-wasting disorders. Atrogi’s lead compound, ATR-258 for type 2 diabetes, completed a Phase 1a/b clinical trial in March 2024, with Phase II trials planned by the end of 2024. Atrogi also has a compounds in pre-clinical development for the treatment of obesity and muscle-wasting disorders.
ATR-258 binds to the β2-adrenoceptor, initiating a process that mediates the transportation of glucose into skeletal muscle, lowering blood glucose levels and positively affecting several organs affected by T2D. The proprietary small-molecule compound activates the receptor in a novel manner, causing selective modulation and a distinct signaling profile.
The company has raised over EUR 24 m in total since inception from investors, including Flerie Invest, Korea Investment Partners (KIP) and private investors. This includes a SEK 90 million (approx. EUR 7.6 m) rights issue. The company has also been awarded non-dilutive grants of over EUR 1.5 million from international organizations such as Eurostars, as well as grants from SweLife in recognition of the company’s unique discovery of receptor signaling.
The company is based in Solna, near Stockholm, Sweden. Follow the company on LinkedIn and visit its website.
Media Contacts
Atrogi
Alexandra Ekman Ryding, CEO
alexandra@atrogi.com
Scius Communications (for Atrogi)
katja@sciuscommunications.com
Tel: +44 7789 435 990
Daniel Gooch
Tel: +44 7747 875 479
daniel@sciuscommunications.com
