A multitude of centers of excellence within MMS worked together globally to support this project, including, Biostatistics, Clinical Programming, Data Management, Interactive Response Technology (IRT), Pharmacovigilance, and Medical Writing.
“The flexibility and seamless working relationship between Gemphire and MMS has proven my confidence in our teams to be one step closer to bringing a product to market that can effectively reduce triglycerides in those that need it most,” said Dr. Uma Sharma, Chief Scientific Officer, MMS. “Our teams are committed to making sound decisions based on strong scientific principles. Our emphasis on being nimble and accommodating across service areas always shines through in the quality of our end deliverables.”
“The choice in collaborating with MMS to meet this milestone for the Phase 2b INDIGO-1 trial was simple, given their deep scientific knowledge and strategic resource models,” said Dr. Steven Gullans, CEO, Gemphire. “There are approximately 3.5 million SHTG patients in the United States in need of lowering their TG levels below 500 mg/dL to reduce their risk of developing acute pancreatitis. The key findings for INDIGO-1 demonstrate promising evidence thus far, and we look forward to advance gemcabene into Phase 3 trials.”
INDIGO-1 was designed as a dose-ranging, 12 week, multicenter, double-blind, placebo-controlled, randomized trial in patients with SHTG (TG =500 mg/dL and < 1500 mg/dL) with or without background statin therapy.
Read the full details on how Gemcabene met both primary and secondary endpoints here: http://ir.gemphire.com/phoenix.zhtml?c=254241&p=irol-newsArticle&ID=2356476
MMS is a global, leading clinical research organization (CRO) that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex regulatory submission challenges. As a data-focused CRO, we are pioneers and leaders in regulatory submissions for our sponsors. Strong industry experience and a data-driven approach to drug development make MMS a valuable partner in creating compelling submissions that meet rigorous regulatory standards. For more information, visit www.mmsholdings.com.
About Gemphire Therapeutics Inc.
Gemphire Therapeutics Inc. (NASDAQ:GEMP) is a clinical-stage biopharmaceutical company that is committed to helping patients with cardiometabolic disorders, including dyslipidemia and NASH. The Company is focused on providing new treatment options for cardiometabolic diseases through its complementary, convenient, cost-effective product candidate gemcabene (CI-1027 licensed from Pfizer in 2011) as add-on to the standard of care, especially statins, that will benefit patients, physicians, and payors. Gemcabene’s lack of drug-drug interactions with highest dose of statins such as Lipitor offer a first-in-class, once-daily oral drug candidate for additional LDL-C, triglycerides (fat), and inflammation lowering.
Gemcabene has been tested as monotherapy and in combination with all doses of statins and other drugs in nearly 1,100 subjects across 23 Phase 1 and Phase 2 clinical trials and has demonstrated promising evidence of efficacy, safety and tolerability. To learn more about gemcabene, click here.