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Gemphire Therapeutics to Advance Gemcabene into Phase 3

Tuesday, September 19, 2017   (0 Comments)
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Gemphire Therapeutics Inc. (NASDAQ: GEMP), a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for cardiometabolic disorders, including dyslipidemia and NASH, today announced plans to advance its product candidate gemcabene into Phase 3 development in 2018. Gemcabene successfully achieved the primary endpoint in two recently completed Phase 2b studies, COBALT-1 and ROYAL-1, and the Company is now preparing for end of Phase 2 meetings with both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), anticipated to take place in early 2018.

 

The primary focus of these meetings is to reach agreement on the design of the Phase 3 development programs for its hypercholesterolemia indications. Twenty clinical studies have shown gemcabene to be safe and effective as monotherapy or in combination with all current treatments for hypercholesterolemia, including the highest intensity statins, PCSK9 inhibitors and ezetimibe, and thus appears to be beneficial for high-risk patients that have not achieved lipid goals.


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