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First Investigational New Drug (IND) approval for Actimed – a significant corporate milestoneApproval 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.
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. Actimed was founded in 2017 by Stefan Anker and Andrew Coats, two eminent physicians in muscle wasting research, together with Yann Colardelle, a professional in communications and medical education who has been involved in research and education in cachexia for many years.
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 cachexia² and it is estimated that cachexia is responsible for up to 20% of all cancer deaths³. A 2023 meta-analysis demonstrated that cachexia was associated with an 82% higher relative risk of mortality in patients with non-small cell lung cancer (NSCLC) versus no cachexia⁴.
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 has received Investigational New Drug (IND) approval for its planned phase 2b/3 clinical studies (IMPACT programme) in cachexia in NSCLC and colorectal cancer (CRC).
Actimed also owns the global rights to its second asset, S-oxprenolol, 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 survival5. 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.
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¹A Coats et al Espindolol for treatment and prevention of cachexia: the ACT-ONE trial. J Cachexia Sarcopenia Muscle 2016; 7: 355–365
²Anker M et al., J. Cachexia, Sarcopenia and Muscle; 2019: 10: 22 – 24
³Argilés JM et al, Nat Rev Cancer 2014; 14:754-62
⁴Bonomi 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
⁵Wolf J et al., PMID 28184974 DOI: 10.1007/s00115-117-0293