Gemphire: Cholesterol med hit primary, secondary goals in Phase 2

Gemphire Therapeutics Inc. (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.

Key findings:

• Primary endpoint met with median TGs significantly decreased by 47% in gemcabene (600 mg) treated patients compared to 27% for placebo-treated patients (P=0.0063; ranked ANCOVA).
• The 600 mg gemcabene group attained a significantly lower median level of serum TGs of 333 mg/dL compared to placebo of 538 mg/dL (P=0.0137) at the end of the study.
• Statistically significant secondary endpoints achieved with 600 mg gemcabene, including placebo-corrected median decreases in LDL-C (24%), non-HDL-C (16%), VLDL-C (19%), apoB (12%), apoE (14%), apoCIII (11%), SAA (23%); (p-values <0.05; ranked ANCOVA).
• No severe adverse events (SAEs) were observed with gemcabene and adverse events (AEs), which were generally mild to moderate, occurred less frequently with gemcabene than placebo.

“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.”

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