Actimed Therapeutics Announces Publication of Successful S-pindolol benzoate (ACM-001.1) Phase 1 Study in The Journal of Cachexia, Sarcopenia and Muscle
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
