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.
We are focused on a broad spectrum of indications for dyslipidemia patients ranging from the orphan indication HoFH to more prevalent conditions, such as HeFH, ASCVD, SHTG, and NASH totaling over 20 million patients and an estimated $33B market size by 2025. To learn more about these clinical indications, click here.
In 2017, Gemphire completed 2 Phase 2b studies: COBALT-1 (HoFH patients; NCT02722408) and ROYAL-1 (HeFH/ASCVD patients; NCT02634151). In Q2 of 2018, we expect to report top-line data from INDIGO-1 (SHTG patients; NCT02944383). We initiated two Phase 2a trials in NASH/NAFLD in late 2017 and early 2018 and expect to report top-line data from these trials in late 2018 and early 2019, respectively. To learn more about our clinical program, click here.
Gemphire is led by an experienced leadership team with a track record of developing novel therapies to treat life threatening cardiovascular/metabolic and orphan diseases from leading companies including Pfizer/Parke-Davis/Warner-Lambert, Esperion, ProNAi, Cerenis, Alphacore, Pipex/Synthetic Biologics, and Pharmacia & Upjohn. Like many biotech companies, we operate on a virtual model with contract partners for manufacturing, clinical operations, regulatory, and preclinical toxicology. In addition, we complement our team with global medical and scientific advisors. To learn more about our team, click here.