The Food and Drug Administration (FDA) OKed phase 2b/3 trials to evaluate the use of S-pindolol benzoate for the treatment of cachexia and other muscle wasting disorders in patients with cancer, according to a press release published Axtimed Therapeutics, the manufacturer of the drug.

Cachexia, also known as wasting syndrome, is a medical condition that causes the body to lose muscle and fat. It can be seen as a symptom of chronic illness and is associated with colorectal cancer and non-small cell lung cancer.

One study (IMPACT CRC) focused on the use of S-pindolol benzoate to treat cachexia in patients with colorectal cancer, while the other study (IMPACT NSCLC) focused on the use of S-pindolol benzoate in patients with non-small cell lung cancer.

Cachexia is known as the secondary disease of cancer that can lead to 20% of cancer deaths, according to the press release. The unmet needs for this disease are extremely significant, as components such as weight loss aren’t tracked within these patients and no globally approved products to treat cachexia are accessible for the patient population.

“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 program for this potential new treatment in this area of high unmet need”, explained Dr. Jose Garcia, 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 program, in the release.

A prior phase 2a with S-pindolol benzoate showed promising results. The study was completed by Actimed and met all objectives for its trial, by showing that in vivo stereo-conversion (from S-pindolol to R-pindolol) was nonexistent and S-pindolol benzoate is biologically equivalent to that present in racemic pindolol — which is used to prevent cachexia — after single and multiple doses with dose-proportional and dose-dependent pharmacokinetics.

S-pindolol benzoate has developed a reliable new therapy for patients with cancer cachexia and reveals anti-catabolic (a product that slows down the breakdown of muscle) and pro-anabolic (a product that stimulates the growth of tissue within the body) pharmacology.

Actimed will fully test S-pindolol benzoate and its reliability within the phase 2b/3 IMPACT clinical trials. The researchers are expected to dose its first trial participant within 2024.

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