Category: Press Release

All endpoints met for novel b₂–adrenoceptor 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.

Atrogi announced today 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 ß₂ 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 (ClinicalTrials.gov identifier: NCT05409924).

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.

This milestone coincides with a clinical publication in Nature Communications (van Beek et al.,) co-authored by Atrogi´s founder Professor Tore Bengtsson. The report describes the beneficial metabolic effects by a ß₂ adrenoceptor agonist and the results “highlight the potential of ß₂-agonist treatment in improving skeletal muscle glucose uptake and underscore the therapeutic value of this pathway for the treatment of type 2 diabetes.”

”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, Ph.D., CEO.

Reference: van Beek, S.M.M., Bruls, Y.M.H., Vanweert, F. et al. Effect of β2-agonist treatment on insulin-stimulated peripheral glucose disposal in healthy men in a randomised placebo-controlled trial. Nat Commun 14, 173 (2023). https://doi.org/10.1038/s41467-023-35798-5

Atrogi is one of a few companies to be selected for a prestigious grant from Eurostars, an initiative of the European Commission that promotes research, and the intergovernmental innovation network EUREKA. The application was done in consortium with Stockholm University, Maastricht University, the Latvian Institute of Organic Synthesis and Excellerate Bioscience. The grant awarded is approx. 1 million EUR.

“We are very proud to we receive this grant and see it as a recognition of our unique discovery of receptor signaling. Our project was ranked 31 out of 449 applications, and this funding will be important for our development of a new treatment for obesity,” said Alexandra Ekman Ryding, CEO of Atrogi.

Eurostars is a funding and support programme for European research-based small and medium companies’ development of innovative products and services. The programme, which has a 1.14 billion EUR budget for the period 2014-2020, is financed by the European Commission and 36 Member State budgets. The jury’s decision was based on a variety of criteria related to innovation and development, market and commercial potential, as well as expertise of the partners behind the project. This is the second time that Atrogi receives funding from Eurostars.

“Obesity is a growing public health problem and finding new forms of treatment is extremely important to us from a societal perspective. We have high hopes for this groundbreaking project that is being implemented with distinguished researchers from top-tier European universities, institutes and organizations,” said Alexandra Ekman Ryding. The project is expected to begin in this fall.

Diabetes company Atrogi has completed a SEK 90 million rights issue for the continued in-house development of a new class of diabetes drug

The Swedish diabetes company Atrogi has recently completed a rights issue, raising approximately SEK 90 million. Among the anchor investors is South Korea’s largest venture capital company Korea Investment Partners (KIP).

“We see the investment by such a strong and experienced player as KIP as powerful confirmation of our groundbreaking research and the market potential for the drug we are developing. In addition, being able to do so in the middle of the corona crisis also sends a strong message,” says Alexandra Ekman Ryding, CEO, Atrogi.

Atrogi is developing a new drug based on a completely new and unique principle for the treatment of diabetes type 2. The patented substance stimulates glucose uptake in muscle cells and is a treatment that is insulin-independent, a significant advantage as the insulin system functions less effectively in diabetics. Pre-clinical trials show several positive effects over and above the primary goal of reducing blood sugar levels in patients.

Atrogi’s drug candidate is currently undergoing pre-clinical development and with the new capital injection, the plan is to carry out a clinical Phase 1 study in 2021. This is a significant and important stage in the process of developing a whole new class of oral type 2 diabetes drugs.

“Current treatments for type 2 diabetes in large part aim to overstimulate the already dysfunctional insulin-based system, and seldom work well. Over time, this means poor efficacy and a risk of serious illness. Our treatment principle is based on a fully functional system in the body which means that these problems can be avoided,” says Professor Tore Bengtsson, founder of Atrogi.

About Korea Investment Partner (KIP)

Korea Investment Partners is Asia’s leading venture capital and private equity firm with 46 active funds and over $2.9B of assets under management. KIP invests in early stage ventures to growth stage companies, across different industries. Recent investments include Vaccitech (UK), PDC Line Pharma (Belgium-France), EnlivexTherapeutics (NASDAQ: ENLV), and Inovio Pharmaceuticals (NASDAQ: INO). KIP operates globally from its Seoul headquarters, with other offices in Silicon Valley, Singapore, and China (Shanghai, Beijing, Chengdu, and GuangZhou).