Actimed Therapeutics secures significant new patent, extending IP coverage of its lead compound for use in key indication

• Provides extended UK patent coverage relating to lead compound S-pindolol benzoate (ACM-001.1) to 2040.
• International patent application also filed in March 2021.

LONDON, May 4, 2022 /PRNewswire/ -- Actimed Therapeutics Ltd, a clinical stage company focused on bringing innovation to the treatment of muscle wasting disorders, today announced the grant of a new UK Patent (GB 2593902 B) covering new salts of S-pindolol for use in the treatment or prevention of cachexia with an expiry date in 2040.

An international patent application has also been filed under the Patent Cooperation Treaty (PCT) and was published in October 2021, which seeks to extend patent protection for new S-pindolol salts to all relevant major international markets out to 2041.

S-pindolol benzoate (ACM-001.1) is the leading development candidate of Actimed and is protected by the patent for use in the treatment of cachexia. Actimed plans on initiating Phase 2b/3 clinical studies of S-pindolol benzoate in 2023.

Robin Bhattacherjee, CEO of Actimed commented: "We are thrilled to confirm the grant of this new patent which includes protection of our new benzoate salt form of S-pindolol for use in the treatment of cachexia. Strengthening our intellectual property portfolio is fundamental to the commercial value of S-pindolol and supports our plans to develop the first globally approved treatment for cancer cachexia, which affects 50 to 80% of cancer patients worldwide. The granted patent provides enhanced and extended protection of S-pindolol benzoate for use in cachexia until 2040 adding significant value to our lead asset and to the Company as a whole."

Cachexia is a wasting syndrome that can be difficult to reverse and remains a significant hurdle in the treatment of cancer. It causes sudden loss of weight, appetite and muscle and accounts for up to 20% of all cancer deaths¹. In nonclinical models, S-pindolol is an anabolic/catabolic transforming agent² with a multifunctional effect on a trio of pharmacological targets which could make it an important candidate for development in cancer cachexia.

The potential clinical utility of S-pindolol benzoate as a therapeutic for the treatment of cancer cachexia is supported by data from the ACT-ONE³ Phase II clinical study of S-pindolol (ACM-001) which was a proof of concept exploratory, randomised, double-blind, placebo-controlled study in 87 patients with non-small-cell lung cancer (NSCLC) or colorectal cancer (CRC). The trial demonstrated that S-pindolol was well-tolerated and that patients receiving the highest dose showed a median weight gain of 2.74kg compared to a median 1.09kg weight loss in patients receiving placebo over a 4-month period.

The newly granted patent follows the commencement in December 2021 of a pharmacokinetic and pharmacodynamic (PK/PD) clinical study of S-pindolol benzoate (ACM001.1) in healthy subjects. Data from this study are expected in the first half of 2022 and will be used to further inform the Phase 2b/3 programme.

About Actimed Therapeutics

Actimed Therapeutics is a clinical stage biopharmaceutical 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 world leading physicians in muscle wasting research.

The lead area of focus for Actimed is specifically in cachexia. Cachexia is a wasting disease that accompanies cancer and other serious chronic illnesses and is associated with significant morbidity and mortality. Despite its prevalence and devastating clinical effects, there is no globally approved drug for the treatment or prevention of cancer-related cachexia.

It has been estimated that cachexia affects 50?80% of cancer patients and accounts for up to 20% of cancer deaths. Treating cancer cachexia successfully may increase both the length and quality of life for cancer patients.

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 II clinical data in cachexia patients. Actimed is currently preparing for further clinical studies in cachexia in Non-Small Cell Lung Cancer (NSCLC) and Colorectal Cancer (CRC).

Actimed has also licensed the global rights to develop and commercialise S-oxprenolol, for cancer cachexia and any other indications outside of amyotrophic lateral sclerosis (ALS) to Faraday Pharmaceuticals. Actimed retains global rights to S-oxprenolol in ALS, where loss of body mass and muscle wasting may impact survival.

FOR MORE INFORMATION

Actimed Therapeutics
www.actimedtherapeutics.com

MEDiSTRAVA Consulting
Frazer Hall, Evelyn McCormack
Tel: +44 (0)203 928 6900
Email: [email protected]

¹ Argilés JM, Busquets S, Stemmler B, Lopez-Soriano FJ. Cancer cachexia: understanding the molecular basis. Nat Rev Cancer. 2014;14:754?62.

² Pötsch MS, et al. The anabolic catabolic transforming agent (ACTA) espindolol increases muscle mass and decreases fat mass in old rats. J Cachexia Sarcopenia Muscle. 2014 Jun;5(2):149-58

³ Coats AJS, et al. Espindolol for the treatment and prevention of cachexia: a randomized, double-blind, placebo-controlled, international multicentre phase II study (the ACT-ONE trial). J. Cachexia Sarcopenia and Muscle 2016 Jun; 7(3):355-365.