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Andrew J. Stewart Coats, Founder and Non-Executive Director
Professor Andrew Coats MBA, DSc, DM, co-founded Actimed Therapeutics in 2017, having previously founded Myotec (later renamed PsiOxus Therapeutics). Andrew has over 30 years of experience as an academic manager, having been both Dean of Medicine and Deputy Vice-Chancellor at the University of Sydney and head of Clinical Cardiology at Imperial College and the Royal Brompton Hospital in London. Andrew also served as CEO of the Norwich Research Park in the UK. Andrew is an experienced board director and chairman with an MBA from London Business School. He has over 20 years of experience of company boards in roles including audit, remuneration, nominations and governance committees in biotechnology, publishing health care and education, including the George Institute of International Health, the Woolcock Institute, Lone Star Heart, Myotec, PsiOxus, Radcliffe Group, ESN Cleer and Faraday (Australia). Andrew has been on the board of the Heart Failure Association (HFA) of the ESC since 2012 and will be its President from 2020 to 2022. He has been a member of over 20 international clinical trial steering committees in the fields of heart failure and cachexia and has over 700 career research papers, 95,000 citations and an h-Index of 130.
Stefan D. Anker, Founder, Non-executive Director & Chair of Scientific Advisory Board
Professor Stefan Anker MD, PhD, co-founded Actimed Therapeutics in 2017, having previously founded Myotec (later renamed PsiOxus Therapeutics). Stefan has 30 years academic research experience in heart failure, cachexia and clinical trials with positions at Royal Brompton Hospital and Imperial College in London as well as University Göttingen and Charité Berlin. Stefan has been a tenured University-Professor in Germany since 2007, leading a highly active research group, and he is founding Editor-in-Chief of two successful scientific journals (including the Journal of Cachexia, Sarcopenia and Muscle). Stefan was Vice President of the European Society of Cardiology (ESC) from 2016 to 2018, and served on the ESC board from 2012 to 2018. He has served on the board of the Heart Failure Association (HFA) of the ESC since 2006; and was HFA President from 2012 to 2014.
Yann Colardelle, Founder
Yann Colardelle is a professional in communications and medical education who has been involved in research and education in cachexia for more than 15 years. In 1998 he founded Medical Education Global Solutions, a leading independent medical education company with a focus on global and multidisciplinary projects.
Yann holds a degree from the University of Provence and an eMBA at Paris Dauphine. As a founder, he envisions Actimed therapeutics as the organisation that will change the paradigm of cachexia management and improve the lives of patients and their families and carers.
London, UK – 4th September 2024. 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, announces that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to S-oxprenolol (ACM-002) for the treatment of amyotrophic lateral sclerosis (ALS).
ALS (also known as Lou Gehrig’s disease) is a progressive, fatal neuromuscular disease that affects nerve cells in the brain and spinal cord, eventually leading to a loss of muscle control and paralysis. ALS prevents motor neurons sending impulses from the brain and spinal cord to the muscles, causing muscle atrophy and weakness and has a mean survival of 3.5 years. Voluntary muscle action is progressively lost and in late-stage ALS patients may have difficulty communicating, swallowing, moving, and breathing. There is currently no cure for ALS.
Cachexia, a complex wasting disease, may occur in the early stages of ALS and has a significant impact on quality of life, proving terminal in some patients. In pre-clinical ALS models, S-oxprenolol has demonstrated significant benefits including slowing disease progression, improvement in survival, attenuation of muscle loss, motor neuron protection, reduction in loss of body mass and improvements in lean body mass1.
Robin Bhattacherjee, Chief Executive Officer of Actimed Therapeutics commented “We are pleased to receive Orphan Drug Designation for S-oxprenolol in ALS, where loss of body mass and muscle wasting can have a significant impact on survival. ALS is a devastating orphan disease of high, unmet medical need and the early non-clinical data we have generated for S-oxprenolol in this indication suggest that it could have a potential role in meeting some of the important needs of this under-served patient population”.
FDA Orphan Drug Designation is granted to investigational therapies which are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions that affect fewer than 200,000 people in the United States. Orphan Drug Designation provides several benefits to drug developers, including certain development cost benefits in the US, increased FDA interaction and eligibility for seven-year market exclusivity following approval.
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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.
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 recent meta-analysis demonstrated that cachexia was associated with an 82% higher relative risk of mortality in patients with 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 is currently preparing for further clinical studies in cancer cachexia having received an Investigational New Drug (IND) approval from FDA for this programme in August 2023.
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.
FOR MORE INFORMATION
Actimed Therapeutics
www.actimedtherapeutics.com
MEDiSTRAVA Consulting
Frazer Hall, Erica Hollingsworth
Tel: +44 (0)203 928 6900
Email: actimed@medistrava.com
1 Suzuki et al, JCSM 2018; 9, 183-212. (Poster 5-17, page 200)
2 Anker M et al., J. Cachexia, Sarcopenia and Muscle; 2019: 10: 22 – 24
3 Argilés JM et al, Nat Rev Cancer 2014; 14:754-62
4 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
5Wolf J et al., PMID 28184974 DOI: 10.1007/s00115-117-0293
trademark registration number 6734037 in the USA