Gemphire reports Phase IIb data of gemcabene for hypercholesterolemia

Gemphire Therapeutics Inc. (NASDAQ:GEMP) reported top-line data from the Phase IIb ROYAL-1 trial in 105 patients with hypercholesterolemia showing that once-daily 600 mg oral gemcabene (CI-1027) met the primary endpoint of reducing mean LDL-C from baseline to week 12 vs. placebo (17.2% vs. 5.5%, p=0.0057). The company said the "magnitude of LDL-C lowering was less than observed in certain prior studies of gemcabene." On a conference call, Gemphire added that the placebo response in ROYAL-1 was higher than expected.

Gemcabene met the secondary endpoint of reducing median high-sensitivity C-reactive protein (hsCRP) levels from baseline to week 12 vs. placebo (40% vs. 6.1%, p<0.0001). The company said gemcabene's utility for reducing hsCRP could differentiate it from competitors in the cardiovascular space...