PsiOxus completes enrollment in MT-102 Phase II trial on cancer cachexia

PsiOxus Therapeutics, Ltd. (PsiOxus), a development stage biotechnology company, has completed patient enrollment for its Phase II clinical trial to study MT-102, a small molecule therapeutic for the treatment of cancer cachexia. The agent's unique dual mode of action, which has both anti-catabolic and pro-anabolic activity, directly impacts two of the principle pathophysiological hallmarks of cachexia and has been shown to have beneficial effects upon both cachexia and age-related sarcopenia in vivo.

Cancer cachexia is a wasting syndrome characterized by loss of muscle and fat, and occurs in the majority of patients with advanced, refractory malignancies. The disease accompanies a wide range of serious illnesses including cancer, heart failure, COPD, renal failure, cirrhosis and rheumatoid arthritis and is associated with significant morbidity and mortality. Sarcopenia is the loss of muscle mass and function that results from the process of aging.

"Cachexia is a very serious, but often underestimated and poorly managed medical consequence of cancer," said Dr. John Beadle, CEO of PsiOxus Therapeutics. "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. There is thus a significant unmet medical need with tremendous market potential for an approved, effective treatment for these patients. Our lead compound MT-102 is a very promising mode of treatment that has shown to have a positive impact on weight change, body composition and physical performance in pre-clinical models. Completion of recruitment in this clinical study is the next critical step in assessing the compound's effectiveness to help fight these wide-spread diseases."

This Phase II multinational, randomized, double blind, placebo controlled clinical study of MT-102 has enrolled 87 patients with Stage III or IV lung cancer or colorectal cancer that are also suffering severe weight loss and fatigue. The trial is designed to demonstrate reversal of weight loss following treatment with MT-102, but will also examine improvement in functional ability and quality of life as quantified by a battery of previously validated instruments.

The human safety profile of MT-102 has been demonstrated in two Phase I/II clinical studies. The preclinical efficacy profile has been demonstrated in both cachexia and sarcopenia. A preclinical model of cancer cachexia found that MT-102 demonstrated superior efficacy relative to other tested agents. MT-102 not only significantly improved body weight, muscle mass, fat mass and mobility, but it also significantly improved survival.