Shares of Gemphire Therapeutics Inc (NASDAQ:GEMP) rocketed in pre-market trade Friday after the clinical-stage biopharmaceutical group reported rosy results from a Phase 2b trial assessing how well its drug gemcabene treats patients with severe hypertriglyceridemia.
In the trial, called INDIGO-1, patients who took 600mg of gemcabene reported far lower triglycerides – as at the median level, their triglyerides fell by 47% compared to a 27% reduction for patients who took a placebo.
Severe hypertriglyceridemia is a condition in which patients have triglycerides, a type of fat, present in the bloodstream at a level greater than 500mg/dL. These high levels are associated with an increase in both the risk for cardiovascular disease and acute pancreatitis.
Prior to the opening bell, Gemphire shares jumped 146% to US$12.89 in response to the good news.
Key endpoints reached
Primary and secondary endpoints were both met in the trial, which lasted twelve weeks and phase 3 trials are expected to follow.
“We are pleased to reach this milestone of meeting both primary and multiple secondary endpoints and look forward to advancing gemcabene into Phase 3 trials,” said Dr Steven Gullans, Gemphire’s chief executive.
“There are approximately 3.5mln patients with severe hypertriglyceridemia in the US who are in need of lowering their triglyceride levels below 500mg/dL to reduce their risk of developing acute pancreatitis,” he added
Another positive to come out of the study was that gemcabene appeared safe and well-tolerated on its own or as an additional therapy to statins.
The INDIGO-1 results also support the company’s plan to use gemcabene as a liver drug to treat non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A pair of phase 2a proof of concept trials assessing gemcabene’s potential to fight NAFLD and NASH are under way, with data expected later this year and early in 2019.
Contact Ellen Kelleher at [email protected]