FDA approval of an investigational NDA for phase IIb/III IMPACT clinical trial of S-pindolol benzoate to treat cancer cachexia

Cachexia has long been recognised as a secondary disease to cancer can lead to up to 20% of cancer deaths. Despite this, weight loss in patients with cancer is rarely assessed or managed actively. Other than supportive care, no globally approved products are available for this patient population so there remains an important unmet need for effective new treatments. S-pindolol has demonstrated promising results in a Phase IIa, proof of concept trial, the ACT-ONE trial, and Actimed has successfully completed a pharmacokinetic/pharmacodynamic (PK/PD) study with S-pindolol benzoate (ACM-001.1) that met all pre-defined objectives. These included demonstrating an absence of in vivo stereo-conversion (from S-pindolol to R-pindolol) and demonstrating that S-pindolol benzoate is essentially bioequivalent to the S-pindolol present in racemic pindolol with dose-proportional and dose-dependent pharmacokinetics after single and multiple doses.

The anti-catabolic and pro-anabolic pharmacology of S-pindolol benzoate position it as a novel and promising new therapy for cancer cachexia. Actimed has designed the Phase IIb/III IMPACT clinical trials programme to allow a full evaluation of the safety and efficacy of S-pindolol benzoate, with plans to dose the first trial participant in 2024.

Jose Garcia MD, PhD, Professor of Medicine at the University of Washington School of Medicine, Director of the Geriatric Research Educational and Clinical Centre (GRECC) at the Puget Sound Veterans Affairs Healthcare System, and US Principal Investigator for the IMPACT trial programme commented “Despite the advances in cancer treatment over recent years, there are few treatment options and no new globally approved products for treating cancer cachexia. This places a tremendous burden on patients, their caregivers and families and can have a direct impact on mortality. I am therefore very pleased to be leading the IMPACT US clinical trial programme for this potential new treatment in this area of high unmet need”.

Elaine Morten PhD, Head of Regulatory Affairs and Technical Development for Actimed Therapeutics commented “Approval of our first IND application is a significant corporate milestone for Actimed and will allow us to begin the critical next phase of our planned clinical studies for our lead compound, S-pindolol benzoate. It is our intention to obtain further clinical trial approvals in other major territories so that, with the necessary funding, we can complete the IMPACT studies as expeditiously as possible”.