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Gemphire Announces Top-Line Data from ROYAL-1 Phase 2b Clinical Trial in Hypercholesterolemic Patients

Gemcabene met the primary endpoint and demonstrated a statistically significant lowering in LDL-C

Company to host conference call at 8:00 am ET, Monday, August 7, 2017

LIVONIA, Mich., Aug. 07, 2017 (GLOBE NEWSWIRE) -- Gemphire Therapeutics Inc. (GEMP) today announced top-line data based upon the Company’s preliminary review of the limited top-line data set from the completed double-blind, placebo-controlled, randomized Phase 2b ROYAL-1 trial. ROYAL-1 evaluated the efficacy, safety, and tolerability of oral gemcabene 600 mg dosed once daily.

ROYAL-1 enrolled patients who were not adequately controlled, with an existing LDL-C value ≥100 mg/dL (2.59 mmol/L) and a TG value < 500 mg/dL (5.65 mmol/L), on stable high- or moderate-intensity statin and/or ezetimibe therapy. Patients were stratified according to background statin intensity and diabetes status. One hundred and five subjects were enrolled at sites in the US and randomized to either gemcabene 600 mg or placebo for a total of 12 weeks. The primary endpoint was the percent change in LDL-C from baseline. Secondary endpoints included safety as well as the percent change from baseline in non-HDL-C, TC, TG, HDL-C, VLDL-C, Apo B, hsCRP and several other biomarkers.

Fifty-six (56) females and 49 males with a mean age of 61 years were enrolled. The mean baseline LDL-C was 130 mg/dL. Gemcabene 600 mg produced a mean percent change in LDL-C of -17.2% vs -5.5% for placebo (ANCOVA:p=0.0057). Gemcabene 600 mg produced a median percent change in hsCRP of -40.0% (ranked ANCOVA: p<0.0001) vs -6.1% for placebo. Additional secondary results and subpopulations assessments will be provided once the full dataset has been analyzed.

“In ROYAL-1, gemcabene met the primary endpoint and demonstrated a statistically significant lowering in LDL-C, although the magnitude of LDL-C lowering was less than observed in certain prior studies of gemcabene,” stated Dr. Lee Golden, Chief Medical Officer. “The company will perform additional analyses to thoroughly evaluate the results of the trial. Once the additional analyses are complete, we will provide an update.”

There were no serious adverse events in the study. Adverse events (AEs) were generally mild to moderate in intensity and consistent with previously reported AEs. Three subjects discontinued from the study, 1 from the gemcabene and 2 from the placebo groups. The subject randomized to gemcabene discontinued because of reported dizziness. No subjects in the study had a transaminase elevation > 3x ULN. One placebo subject had a creatine kinase elevation > 5x ULN on...