London, UK – 13th December 2024. Actimed Therapeutics Ltd (“Actimed”), a UK based clinical stage speciality pharmaceutical company focused on bringing innovation to the treatment of cancer cachexia and other muscle wasting disorders, announces that results from its Phase 1 pharmacokinetic (PK), pharmacodynamic (PD) and bioavailability study of S-pindolol benzoate (ACM-001.1) in healthy volunteers (NCT06028321) have been published in The Journal of Cachexia, Sarcopenia and Muscle.
This was a two-stage Phase I study. The first stage assessed the comparative bioavailability and pharmacokinetics of a single dose of S-pindolol benzoate and two single doses of racemic pindolol. The second stage evaluated the steady-state pharmacokinetics and pharmacodynamics of multiple doses of S-pindolol benzoate in healthy volunteers.
The study met all pre-defined endpoints, demonstrating that S-pindolol benzoate has predictable pharmacokinetics up to a dose of 15 mg twice daily, with low inter-subject variability after single and multiple doses. Moreover, bioavailability of S-pindolol after equivalent doses of racemic pindolol and S-pindolol benzoate was comparable, and although not a prespecified objective, formal bioequivalence margins were met.
The study also showed:
- An absence of in vivo stereo-conversion of S-pindolol into R-pindolol
- Dose linearity and dose proportionality of S-pindolol benzoate over a wide range of doses
- S-pindolol benzoate was generally well tolerated
- A lack of food effect with S-pindolol benzoate - and an important consideration for use in cancer patients who have a high incidence of appetite loss
Robin Bhattacherjee, Chief Executive Officer of Actimed Therapeutics commented “The anti-catabolic and pro-anabolic pharmacology of our lead compound S-pindolol benzoate position it as a novel and promising new therapy for cancer cachexia. These data demonstrate that S-pindolol benzoate is essentially bioequivalent to the S-pindolol present in racemic pindolol and provide strong support for the further clinical development of S-pindolol benzoate for the treatment of cancer cachexia and potentially other conditions associated with muscle wasting”.
The publication may be accessed here: https://doi.org/10.1002/jcsm.13651
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About Actimed Therapeutics
Actimed Therapeutics is a clinical stage speciality 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 deaths2. A recent meta-analysis demonstrated that cachexia was associated with an 82% higher relative risk of mortality in patients with NSCLC versus no cachexia3.
Despite its prevalence and devastating clinical effects, there is no globally approved drug for the treatment or prevention of cancer-related cachexia.
The lead product of Actimed, S-pindolol benzoate (ACM-001.1) targets multiple pathways that drive cachexia and has generated promising proof of concept Phase 2a clinical data in cachexia patients. Actimed is currently preparing for further clinical studies in cancer cachexia having received an Investigational New Drug (IND) approval from FDA for S-pindolol benzoate in August 2023 for the treatment of cancer cachexia.
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 Orphan Drug Designation to S-oxprenolol for the treatment of ALS by the FDA 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
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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
