Phase IIb Trial for Isomyosamine Begins

“The initiation of our Phase IIb isomyosamine trial marks an important milestone in our mission to develop a novel science for immuno-metabolic regulation and increased longevity,” said Mitchell Glass, M.D., President and Chief Medical Officer of TNF. “A deeper exploration of isomyosamine’s efficacy will be studied in patients with acute post-surgical inflammation and complications from hip or femur fractures. In addition to further functional decline, these patients face a higher likelihood of complications that can compromise or delay recovery and are associated with higher healthcare costs.”

According to Jay Magaziner, Ph.D., Director of the Center for Research on Aging at the University of Maryland and founder of the Baltimore Hip Studies project that evaluates outcomes after hip fractures in older patients, “After hip fracture, older patients can precipitously lose bone, muscle, and function, which is associated with a systemic inflammatory response. If we can block this inflammatory response, we have a chance to reduce the amount of muscle loss and the associated functional loss, leading to better outcomes in hip fracture among older persons.”

The upcoming Phase IIb trial to be initiated at the University of Florida is a randomized, placebo-controlled, double-blind study evaluating the efficacy and safety of isomyosamine in reducing inflammation in patients with sarcopenia undergoing fracture repair. Sixty patients will be treated with isomyosamine or placebo for up to 90 days after surgery. The study will measure the extent and time course of recovery to evaluate functional improvement, comparing active dosing to placebo.

The site’s principal investigator is Porter Young, M.D., an assistant professor of orthopaedic surgery and rehabilitation at the University of Florida. His research centers on acetabulum fractures, pelvis fractures, periarticular fractures and management of polytrauma patients.

Isomyosamine is an oral, next-generation TNF-α inhibitor with the potential to transform the way TNF-α based diseases are treated due to its selectivity and ability to cross the blood brain barrier. Its ease of oral dosing is a significant differentiator compared to currently available TNF-α inhibitors, all of which require delivery by injection or infusion. Isomyosamine has also been shown to selectively block TNF-α action where it is overactivated without preventing it from doing its normal job of responding to routine infection. In addition, in early clinical studies it has not been associated with serious side effects known to occur with traditional immunosuppressive therapies that treat inflammation.