- Two-part clinical study programme to evaluate change in lean and fat mass in patients receiving two different doses of S-pindolol benzoate whilst 1) receiving the GLP-1 agonist semaglutide; and 2) after cessation of semaglutide treatment
- Initial proof-of-concept data expected in second half of 2026
London, UK – 25 June 2025. Actimed Therapeutics Ltd (“Actimed”), a UK based clinical stage specialty pharmaceutical company focused on the treatment of cancer cachexia and other muscle wasting disorders, today announces that the first patients have been enrolled in the Company’s Phase 2a muscle optimisation trial PROACT (Preserving, Restoring, and Optimising (lean mass and muscle) with ACTAs) investigating the use of S-pindolol benzoate in combination with GLP-1 receptor agonists in the management of obesity and related complications.
PROACT is a two-part clinical study programme designed to investigate the safety and the efficacy of S-pindolol benzoate in obese patients. PROACT has two independent primary objectives; firstly, to evaluate the change in lean and fat mass in patients receiving two different doses of S-pindolol benzoate whilst also receiving the GLP-1 agonist semaglutide; and secondly, to evaluate the change in lean and fat mass in patients receiving S-pindolol benzoate after cessation of semaglutide treatment. The main secondary endpoints will be to evaluate the potential role of S-pindolol benzoate on muscle mass, heart and bone composition. Initial data from this proof-of-concept study are expected in the second half of 2026.
Fabio Dorigotti, Actimed Chief Medical Officer, commented: “The role of S-pindolol benzoate, with its unique pro-anabolic and anti-catabolic profile, in improving muscle mass has been demonstrated in previous clinical trials in patients with cancer cachexia. We believe the PROACT study will also confirm the benefit of S-pindolol benzoate in preserving muscle mass when used alongside GLP-1 agonists and in optimising and restoring muscle mass after GLP-1 therapy in obese subjects. Our Phase 2a study is designed and powered to give us early proof of concept in this setting, and we look forward to communicating results from the study later next year.”
Marija Zdravkovic, MD, PhD, FESC, CEO, University Hospital Medical Center Bezanijska kosa, Belgrade, Serbia, added “I am excited to be part of the PROACT study and to contribute to advancing innovative strategies for obesity care. I am particularly delighted that the study will be performed in Serbia and am optimistic that this trial will yield valuable insights and pave the way for a more comprehensive approach to obesity management.
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About Actimed Therapeutics
Actimed Therapeutics is a clinical stage specialty pharmaceutical company focused on advancing muscle health in cancer cachexia, obesity and other muscle wasting disorders.
Cachexia is a wasting disease that is associated with cancer and other serious chronic illnesses and with significant morbidity and mortality. A significant number of cancer patients suffer from cachexia and despite its prevalence and devastating clinical effects, there is no globally approved drug for the treatment or prevention of cancer-related cachexia.
In obese patients receiving current GLP-1RAs for weight loss, muscle preservation is a challenge and new approaches are desirable that preserve a healthy body weight composition.
Actimed is currently preparing for further clinical studies of its lead product ACM-001.1 (S-pindolol benzoate) which is an anti-catabolic and pro-anabolic transforming agent (ACTA) targeting multiple pathways that drive cachexia and muscle preservation. Previous studies with S-pindolol have generated promising Phase 2a proof of concept data in cancer cachexia patients and Actimed has conducted a pharmacokinetic and pharmacodynamic (PK/PD) study of S-pindolol benzoate to characterise this new form. In addition, early non-clinical data confirm a potential role for ACM-001.1 in preserving muscle mass when used in combination with GLP-1s for weight loss.
Actimed also owns the global rights to S-oxprenolol (ACM-002), which is being developed to treat the muscle wasting and loss of body mass seen in amyotrophic lateral sclerosis (ALS) where it may impact survival. US Orphan Drug Designation has been granted to S-oxprenolol for the treatment of ALS. Actimed has licensed the global rights to develop and commercialise S-oxprenolol for all other indications outside of ALS to US company Faraday Pharmaceuticals.
FOR MORE INFORMATION
Actimed Therapeutics
www.actimedtherapeutics.com
MEDiSTRAVA
Frazer Hall, Erica Hollingsworth
Tel: +44 (0)203 928 6900
Email: actimed@medistrava.com
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1 Anker M et al., J. Cachexia, Sarcopenia and Muscle; 2019: 10: 22 – 24
2 Argilés JM et al, Nat Rev Cancer 2014; 14:754-62
3 Bonomi P. et al. The mortality burden of cachexia in patients with non-small-cell lung cancer: A meta-analysis; International Conference of Sarcopenia, Cachexia and Wasting Disorders, June 17 – 18 2023, Stockholm, abstract 2-18, page 139
⁴ Wolf J et al., PMID 28184974 DOI: 10.1007/s00115-117-0293
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