London, UK – 23rd September 2026. Actimed Therapeutics Ltd (“Actimed”) has successfully completed patient recruitment for the PROACT Study (Protocol ACM 001 2024 01 CT; NCT07101939), a two part, Phase 2a, randomised, double blind, placebo controlled trial evaluating S-pindolol benzoate (ACM 001.1) in obese adults receiving semaglutide and in those who have discontinued semaglutide.
The PROACT Study enrolled more than 100 patients achieving the planned sample size on time. The study is designed to investigate a critical gap in obesity therapeutics: the preservation of lean body mass (LBM) during GLP 1 receptor agonist (GLP-1RA) therapy and the optimization of body composition after GLP-1RA discontinuation. The loss of LBM is an unwanted effect and a potentially serious concern, particularly for older or frail patients or patients with co-morbidities. Moreover, cessation of GLP-1RA therapy can result in a rebound in body weight in favour of fat mass and at the expense of LBM, resulting in a less favourable muscle to fat ratio.
The PROACT design uniquely evaluates ACM 001.1 in both phases of GLP-1RA treatment - during active semaglutide use and after semaglutide cessation, when weight regain may often occur.
Fabio Dorigotti, MD, Actimed Chief Medical Officer said “Completing recruitment in the PROACT Study is a major milestone for Actimed. This trial is the first to rigorously evaluate a targeted anabolic catabolic transforming agent both during semaglutide therapy and after its discontinuation. GLP-1RAs have reshaped obesity care, but the associated loss of lean mass remains a clinically significant challenge. Our study is designed to directly address this gap, and we look forward to generating robust data that will inform the future development of S-pindolol benzoate.”
Robin Bhattacherjee, Actimed Chief Executive Officer added “We are proud to have completed enrolment in this innovative Phase 2a study, and we thank our investigators and participants for their commitment. PROACT is uniquely structured to answer questions that matter to clinicians, patients and health systems as GLP 1 therapies become increasingly widespread. With recruitment now successfully achieved, we are focused on completing this study and delivering high quality data to advance S-pindolol benzoate toward its next phase of development.”
About the PROACT Study
A Two-part Study Design Built to Answer Two Independent Questions
The PROACT Study incorporates a two period, cross over design for Arms 1 and 2, and a parallel group design for Arm 3, enabling the evaluation of S-pindolol benzoate (ACM 001.1) in two distinct clinical contexts:
1. Patients receiving semaglutide
These patients receive semaglutide and either 10 mg or 15 mg S-pindolol benzoate BID or placebo, to determine whether S-pindolol benzoate can preserve lean body mass during GLP-1RA induced weight loss.
2. Patients after semaglutide cessation
Patients receive semaglutide for 20 weeks and are then re randomised to S-pindolol benzoate (10 mg or 15 mg BID) or placebo for another 20-week period, allowing evaluation of the potential of S-pindolol benzoate to improve the proportion of lean mass in weight regained post GLP-1RA therapy.
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 associated with cancer and other serious chronic illnesses, characterised by severe weight loss and is associated with significant morbidity and mortality. Despite its prevalence in cancer patients and devastating clinical impact, there is no globally approved therapy for the treatment or prevention of cancer-related cachexia.
In obese patients receiving GLP-1RAs for weight management, reductions of lean muscle mass can occur alongside fat loss. Preserving muscle while achieving healthy weight reduction remains an important unmet need, highlighting the opportunity for novel approaches that support and preserve a healthy body composition.
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 the benzoate salt of S-pindolol. In addition, early non-clinical data confirms a potential role for S-pindolol benzoate in preserving muscle mass when used in combination with a GLP-1 agonist 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.
(1) Stenson K et al. Health-related quality of life across disease stages in patients with amyotrophic lateral sclerosis: results from a real-world survey. J Neurol 271, 2390–2404 (2024)
(2) Maciel Ac et al The Impact of Respiratory Function on Functionality and Mortality in ALS Patients J. Clin. Med. 2025, 14(19), 6702
FOR MORE INFORMATION
Actimed Therapeutics
www.actimedtherapeutics.com
MEDiSTRAVA
Frazer Hall, Erica Hollingsworth
Tel: +44 (0)203 928 6900
Email: actimed@medistrava.com
