Actimed Therapeutics announces FDA approval of its Investigational New Drug application for Phase 2b/3 IMPACT clinical trials of S-pindolol benzoate to treat cancer cachexia

• First Investigational New Drug (IND) approval for Actimed  - a significant corporate milestone
• Approval granted for the IMPACT programme – IMProving cancer cachexia with ACTAs (Anabolic/Catabolic Transforming Agents): one study treating cachexia associated with colorectal cancer (CRC) and another in non-small cell lung cancer (NSCLC)
• Actimed to initiate this international clinical development programme for S-pindolol benzoate in cancer cachexia, pending completion of Series B financing, and plans to dose first patient in 2024

London, UK – 7 September 2023. Actimed Therapeutics Ltd (“Actimed”), a UK based clinical stage specialty pharmaceutical company focused on bringing innovation to the treatment of cancer cachexia and other muscle wasting disorders, today announces that it has received approval from the US FDA for its IND application for one Phase 2b/3 clinical study of S-pindolol benzoate (the “IMPACT” clinical trial programme) to treat cachexia associated with colorectal cancer (IMPACT CRC) and  another in patients with non-small cell lung cancer (IMPACT NSCLC).

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 2a, proof of concept trial, the ACT-ONE trial¹, 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 2b/3 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”.

Earlier this year, Actimed commenced the preparations to formally launch its Series B financing round which is designed to fund the IMPACT clinical programme to completion. WG Partners, a London-based Life Sciences specialist advisory firm, is assisting Actimed in the Series B financing which is now well advanced.