Gemphire Announces Top-Line Data from ROYAL-1 Phase 2b Clinical Trial in Hypercholesterolemic Patients
GEMPHIRE THERAPEUTICS INC COMMON (GEMP)
Last gemphire therapeutics inc common earnings: 5/9 04:02 pm
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Source: GlobeNewswire
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. (NASDAQ: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 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% (
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