• Two-part preclincal and clinical development programme launched to assess potential benefits of administering S-pindolol benzoate during and post-GLP-1 receptor agonist therapy to improve muscle mass, cardiac protection and bone mineral density in obese subjects.

London, UK – 20^th May 2025. Actimed Therapeutics, a UK-based clinical stage specialty pharmaceutical company focused on the treatment of cancer cachexia and other muscle wasting disorders, today announces the commencement of a new development programme investigating the potential benefits of using S-pindolol benzoate (ACM-001.1) during and post-GLP-1 receptor agonist (GLP-1RA) therapy in the management of obesity and related metabolic conditions.

This new initiative comprises a two-part programme:

1. A preclinical programme, designed to explore the pharmacological mechanisms, safety and efficacy of S-pindolol in a diet-induced model of obesity in animals who are receiving or who have received a GLP-1 RA. The in vivo phase of these studies has completed, and they will be reported in the coming months.
2. PROACT (Preserving, Restoring, and Optimising (lean mass and muscle) with ACTAs) – a Phase 2a clinical trial, which will assess the safety and efficacy of S-pindolol benzoate in obese patients during and post-GLP-1 RA therapy. The first patient is expected to be enrolled by mid-year.

Approved GLP-1RAs have shown significant efficacy in reducing fat mass, but this is frequently accompanied by an unwanted reduction in lean body mass (LBM), including skeletal muscle^1,2. The loss of LBM is of particular concern in older or frail individuals or patients with co-morbidities as it could lead to impaired function and increased morbidity. 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 ratio³.

S-pindolol benzoate is an agent with pro-anabolic and anti-catabolic properties, and in both nonclinical and clinical studies of cancer cachexia, has demonstrated the ability to improve muscle mass. This suggests a potential utility in obese patients during or following GLP-1RA therapy. Moreover, through its ß1-adrenoreceptor blocking effects, S-pindolol has the potential to enhance cardiovascular benefits associated with GLP-1RAs.

Robin Bhattacherjee, Actimed CEO, commented: “We are extremely excited to announce the launch of this new development programme, PROACT, which is a natural extension of our mission to address serious muscle wasting conditions. We believe the use of S-pindolol benzoate in patients receving or who have received GLP-1RAs represents a highly promising therapeutic strategy. This programme underscores our continued commitment to advancing innovative therapies that can significantly improve outcomes for patients at risk of muscle wasting.”

Dr David Ebsworth, Actimed Executive Chairman, commented:  "This programme represents a thoughtful and strategic expansion of our development pipeline. By leveraging the unique properties of S-pindolol benzoate in combination with GLP-1RAs, we are addressing a significant unmet need while remaining firmly aligned with our strategic focus on muscle wasting disorders. We would like to thank our lead investors for their continued support, which enables us to pursue opportunities like this that are both scientifically compelling and commercially promising."

The company remains fully committed to the ongoing development of S-pindolol benzoate for cancer cachexia and is continuing efforts to raise funds for the IMPACT clinical programme.

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About Actimed Therapeutics 
Actimed Therapeutics is a clinical stage specialty pharmaceutical company focused on bringing innovation to the treatment of muscle wasting disorders to transform the care of an underserved and vulnerable patient population.

The lead area of focus for Actimed is specifically in cachexia. 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 cachexia¹ and it is estimated that cachexia is responsible for up to 20% of all cancer deaths¹. A recent meta-analysis demonstrated that cachexia was associated with an 82% higher relative risk of mortality in patients with NSCLC versus no cachexia¹.

Despite its prevalence and devastating clinical effects, there is no globally approved drug for the treatment or prevention of cancer-related cachexia. 

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 cancer cachexia. Previous studies with S-pindolol have generated promising Phase 2a proof of concept data in cachexia patients and Actimed has conducted a pharmacokinetic and pharmacodynamic (PK/PD) study of S-pindolol benzoate to characterise this new form.  ACM-001.1 has achieved Investigational New Drug (IND) status from FDA.

Actimed also owns the global rights to its second asset, S-oxprenolol (ACM-002), which is being developed by the Company for the muscle wasting seen in amyotrophic lateral sclerosis (ALS) where loss of body mass and muscle wasting may impact survival⁴. Actimed was granted US Orphan Drug Designation to S-oxprenolol for the treatment of ALS in 2024. Actimed has licensed the global rights to develop and commercialise S-oxprenolol for cancer cachexia and any 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

¹Wilding JPH, Batterham RL, Calanna S, et al. (2021) N Engl J Med.;384 (11):989–1002. doi: 10.1056/NEJMoa2032183

²McCrimmon RJ, Catarig A-M, Frias JP, et al. (2020) Diabetologia.;63:473–485. doi: 10.1007/ s00125-019-05065-8

³Wilding JPH, Batterham RL, Davies M, et al. Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension. Diabetes Obes Metab. 2022; 24(8): 1553-1564. doi:10.1111/dom.14725

⁴Anker M et al., J. Cachexia, Sarcopenia and Muscle; 2019: 10: 22 – 24

⁵Argilés JM et al, Nat Rev Cancer 2014; 14:754-62

⁶ 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

⁷ Wolf J et al., PMID 28184974 DOI: 10.1007/s00115-117-0293