Gemphire Announces Termination of Phase 2a Clinical Trial of Gemcabene in Pediatric NAFLD
GEMPHIRE THERAPEUTICS INC COMMON (GEMP)
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Source: GlobeNewswire
LIVONIA, Mich., Aug. 10, 2018 (GLOBE NEWSWIRE) -- 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), announces today that the Data and Safety Monitoring Board (DSMB) at Emory University School of Medicine overseeing the investigator-led open label Phase 2a proof-of-concept trial evaluating gemcabene in pediatric patients with non-alcoholic fatty liver disease (NAFLD) has recommended that the trial be terminated due to unanticipated problems. This pediatric NAFLD trial was initiated in early 2018. Patients were treated with gemcabene at a dose of 300 mg once daily. The primary endpoint is a measure of the change in serum alanine transaminase (ALT), an enzyme that serves as a biomarker of liver function, from baseline to 12 weeks, and secondary endpoints include, among others, change in hepatic steatosis
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