Advancing a class on top of statins
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About Gemphire

Gemphire Therapeutics Inc. (NASDAQ:GEMP) is a clinical-stage biopharmaceutical company headquartered in Michigan that is developing and commercializing therapies to help patients with cardiometabolic disorders, including dyslipidemia and NASH. We are focused on providing new treatment options for cardiometabolic diseases through our 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 895 subjects across 18 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.

Gemphire has launched 3 Phase 2b studies: COBALT-1 (HoFH patients; NCT02722408), ROYAL-1 (HeFH/ASCVD patients; NCT02634151), and INDIGO-1 (SHTG patients; NCT02944383), with a fourth planned trial in NASH (AZURE-1). 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.

History

Gemphire Therapeutics Inc. is a clinical-stage biotech company headquartered in Michigan. Gemphire licensed its lead asset gemcabene from Pfizer Inc. in 2011. Gemcabene, an oral once-daily drug candidate, is being developed to treat the large unmet medical need of patients with high cardiovascular and pancreatitis risk who are unable to reach optimal LDL cholesterol or triglyceride levels with statin or other therapies.

Product

Our current product candidate, gemcabene, is a novel, first-in-class, small molecule therapy designed to target known lipid metabolic pathways to lower levels of LDL-C (bad cholesterol), hsCRP (inflammatory markers), and TG (triglycerides). To date, gemcabene has been tested as a single agent and in combination with statins in 895 subjects in 17 completed clinical trials, including 7 Phase 2 trials. In these studies, gemcabene has been well tolerated compared to placebos and effective in consistently lowering LDL-C by ~30%, hsCRP by ~40%, and triglycerides by ~40%.

Target Markets

Gemcabene represents a potential therapy to add to the portfolio of existing lipid lowering drugs. Homozygous Familial Hypercholesterolemia (HoFH) is a rare genetic lipid disorder inherited from both parents, resulting in impaired or total loss of function in the LDL receptor. Most patients with HoFH do not reach treatment goals and are at a high risk of cardiovascular disease. Gemphire is focused on pursuing the clinical development and commercialization of gemcabene to fill unmet needs for HoFH and dyslipidemia patients. See Products and Trials for more details.

Management

Gemphire is led by an experienced leadership team which is headquartered in Michigan 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.

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