Actimed Therapeutics enrolls first patients in Phase 2a PROACT study programme
- 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 the 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 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 benzote 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.