Pemvidutide

Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and non-alcoholic steatohepatitis (NASH). Pemvidutide incorporates the EuPort^TM domain, a proprietary technology that increases its serum half-life for weekly dosing and may slow the entry of pemvidutide into the bloodstream for improved tolerability. Pemvidutide also has been shown to substantially decrease the amount of fat within the liver which could have beneficial effects on insulin resistance and cardiorenal risk, common problems in people with obesity. In clinical trials, pemvidutide demonstrated striking reductions in body weight, liver fat, serum lipids and markers of liver inflammation.

Pemvidutide is a dual receptor agonist that can activate both GLP-1 and glucagon receptors and thereby mimic the complementary effects of diet and exercise on weight loss. The GLP-1 activity of pemvidutide is expected to suppress appetite while its glucagon activity is expected to increase energy expenditure and the burning of fat. By combining GLP-1 and glucagon activity in a single peptide containing a EuPort domain, pemvidutide has the potential to achieve significant weight loss without the need for a long and inconvenient dose-titration regimen.

A Phase 1 randomized, placebo-controlled clinical trial of pemvidutide in obese and overweight volunteers has been completed. After receiving 12 weekly doses of pemvidutide, significant weight loss occurred in each of the pemvidutide treated groups compared to placebo. At the 1.8 mg dose, 100% participants lost at least 5% of weight, and more than half lost more than 10% of the body weight in 12 weeks.

It is estimated that nearly 80 million¹ people in the United States have non-alcoholic fatty liver disease (NAFLD). If unaddressed, NAFLD may progress to NASH, where excess fat in the liver causes chronic inflammation leading to fibrosis, and eventually cirrhosis. Currently, there are no approved treatments for NASH.

In a Phase 1b randomized, placebo-controlled study of pemvidutide in subjects with NAFLD, significant reductions in liver fat content and markers of liver inflammation were observed after only 12 weeks. At the 1.8mg dose, subjects saw relative reduction in liver fat of 69% as measured by MRI-PDFF, and up to a 21% reduction in serum alanine aminotransferase (ALT) levels. In addition to these important effects, pemvidutide also resulted in significant weight loss in the subjects.

The ability of pemvidutide to rapidly, and significantly, reduce liver fat content, liver inflammation and body weight is unique among current NASH therapeutic candidates.