UK-based development stage biotechnology company PsiOxus Therapeutics has finished enrolling patients in a double-blind, multinational, placebo-controlled, randomised Phase II clinical study of its small molecule therapeutic for the treatment of cancer cachexia, a wasting syndrome characterised by loss of muscle and fat.
The MT-102 therapeutic has dual mode of action involving anti-catabolic and pro-anabolic activity, which directly impacts two of the principle pathophysiological hallmarks of cachexia.
PsiOxus Therapeutics CEO Dr John Beadle said cachexia is a very serious, but often underestimated and poorly managed medical consequence of cancer.
"Historically, treatment has focused on the underlying illnesses that predispose patients to cachexia, and it is only very recently that cachexia has been regarded as a treatable syndrome in its own right," Beadle said.
An in-vivo study of the drug has demonstrated it to have beneficial effects upon both cachexia and age-related sarcopenia, a loss of muscle mass and function that results from the process of aging.
The Phase II study, which has enrolled 87 patients with stage III or IV lung cancer or colorectal cancer and severe weight loss and fatigue, is designed to demonstrate the reversal of weight loss following treatment with MT-102.
The trial will also examine improvement in functional ability and quality of life as quantified by a battery of previously validated instruments.
A preclinical model of cancer cachexia found that MT-102 demonstrated superior efficacy, improved body weight, muscle mass, fat mass and mobility, as well as survival.
The company said it has also demonstrated the human safety profile of MT-102 in two Phase I/II clinical studies, and preclinical efficacy profile in both cachexia and sarcopenia.