Gemphire's INDIGO-1 Passes With Flying Colors; Stock Up Over 120%

(RTTNews) - Shares of Gemphire Therapeutics Inc. (GEMP) were up more than 120% in extended trading on Thursday, following encouraging results from its phase IIb trial of Gemcabene in severe hypertriglyceridemia patients.

In the trial, dubbed INDIGO-1, Gemcabene demonstrated statistically significant lowering of triglycerides - with median triglycerides being significantly reduced by 47% in Gemcabene (600 mg)-treated patients compared to 27% for placebo-treated patients.

To be more specific, Gemcabene 600 mg treatment reduced median triglycerides (TGs) levels from a baseline of 637 mg/dL to 333 mg/dL, compared to placebo treated patients with a median baseline of 658 mg/dL reduced to 538 mg/dL.

People with TG levels above 500 mg/dL are at an increased risk for acute pancreatitis, a very serious and potentially lethal complication of severe hypertriglyceridemia.

The trial also achieved secondary endpoints - demonstrating statistically significant reductions in serum LDL-C, non-HDL-C, VLDL-C, apoB, apoE, apoCIII, and serum amyloid A (SAA). Gemcabene appeared safe and well-tolerated as monotherapy or as add-on to statins, noted the Company.

Gemphire believes that the INDIGO-1 results further support its rationale for pursuing Gemcabene to treat NAFLD/NASH.

A phase IIa proof-of-concept clinical trial of Gemcabene in adults with familial partial lipodystrophy (FPL), a rare genetic disorder characterized by an abnormal distribution of fatty tissue, which can lead to a variety of metabolic abnormalities including NASH, was initiated in December 2017. Another phase IIa proof-of-concept clinical trial investigating Gemcabene as a treatment for pediatric nonalcoholic fatty liver disease (NAFLD) was initiated in January of this year.

Both the ongoing NAFLD/NASH proof-of-concept trials are dosing patients and remain on track to report data in late 2018 and early 2019.

GEMP closed Thursday's trading at $5.24, down 5.07%. In after-hours, the stock was up 124.24% to $11.75. The stock has traded in a range of $4.75 to $21.59 over the last 1 year.