Gemcabene Meets Primary Endpoint in INDIGO-1 Study of Severe Hypertriglyceridemia (SHTG) Patients

Gemphire Therapeutics (NASDAQ:GEMP), a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for cardiometabolic disorders, including dyslipidemia and nonalcoholic steatohepatitis (NASH), today announced that it achieved the primary endpoint, reduction of TGs by gemcabene, in its Phase 2b INDIGO-1 trial in SHTG patients with baseline serum TGs >500 mg/dL.

As quoted in the press release:

“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, CEO of Gemphire. “There are approximately 3.5 million SHTG patients in the United States in need of lowering their TG levels below 500 mg/dL to reduce their risk of developing acute pancreatitis. Our once daily tablet has demonstrated promising evidence of safety, efficacy and tolerability in more than 1,100 subjects thus far. Moreover, in prior studies 600 mg of gemcabene reduced LDL-C, hsCRP and other biomarkers that are typically elevated in a broad range of dyslipidemic conditions.”

INDIGO-1 was designed as a dose-ranging, 12 week, multicenter, double-blind, placebo-controlled, randomized trial in patients with SHTG (TG ≥500 mg/dL and < 1500 mg/dL) with or without background statin therapy. All patients enrolled in the study were also counseled on the importance of maintaining a heart-healthy diet and limiting alcohol intake. Patients were enrolled into one of three arms: gemcabene 300 mg (n=30), gemcabene 600 mg (n=30) or placebo (n=31) once daily. Demographically the 3 groups were comparable: ~40% diabetic, 50% on statin therapy, median Body Mass Index (BMI) ~31-32, and mean age of 54; one group difference was a larger proportion of females in the placebo group (39%) compared to the gemcabene groups (300 mg: 3%; 600 mg: 17%).  The primary endpoint was median percent change in TGs from baseline to the end of study (defined as the average of weeks 10 and 12). Other endpoints associated with atherogenic burden included percent changes in LDL‑C, hsCRP, apoB, non-HDL‑C, very-low-density lipoprotein cholesterol (VLDL-C) and total cholesterol.

Click here to read the full press release.