Gemphire Therapeutics plans to advance its product candidate gemcabene into Phase 3 development in 2018 and is preparing for end of Phase 2 meeting w/ the FDA and EMA in early 2018
"I believe we have accumulated a compelling body of clinical data demonstrating the ability of gemcabene to reduce low density lipoprotein cholesterol (LDL-C) in both orphan and broad dyslipidemic conditions," said Dr. Steven Gullans, Interim CEO of Gemphire. "Gemcabene is a unique late stage clinical asset and the only compound in development across the full spectrum of dyslipidemia that targets the triple threat of LDL-C, inflammation and triglycerides (TG). We look forward to reviewing these data with the FDA and EMA to seek agreement on the design of our comprehensive Phase 3 clinical program to confirm the benefits observed in prior studies and to support regulatory approval for the various indications and commercialization in the major markets."
- 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 FDA and 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.
- ROYAL-1 study accepted for presentation at AHA Scientific Sessions in November 2017.
- COBALT-1 study to be presented at the FH Foundation's Summit meeting on Monday, September 25th.
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