LIVONIA, Mich., Oct. 31, 2016 (GLOBE NEWSWIRE) -- Gemphire Therapeutics Inc. (NASDAQ:GEMP), a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for the treatment of dyslipidemia, today announced that the European Patent Office has granted European Patent No. 2658536 Gemcabene and Derivatives for Treating Pancreatitis covering the use of gemcabene for decreasing the risk of developing pancreatitis in patients having a blood triglyceride level of 500 mg/dL or higher.
Elevated triglycerides are often caused by an inherited disorder or exacerbated by uncontrolled diabetes mellitus, obesity, hypothyroidism and sedentary habits. Patients with triglycerides greater than 500 mg/dL, or severe hypertriglyceridemia (SHTG), have increased risk of developing pancreatitis, a painful and potentially life-threatening inflammation of the pancreas, and Type 2 diabetes. There are over 3 million patients in the United States and tens of millions of patients in the rest of the world with SHTG. There are reports that about 300,000 patients are admitted to hospitals each year in the U.S. as a result of pancreatitis (representing 1 in 10 SHTG patients), and about 20,000 patients annually die from the disease.
Dr. Charles Bisgaier, Co-Founder and Chief Scientific Officer of Gemphire, and sole inventor on this patent, stated that, “There is a well-established link between high triglyceride levels (≥500 mg/dL) and pancreatitis, making this European Patent important because gemcabene may become a valuable treatment option to prevent acute pancreatitis by lowering triglyceride levels. In Phase 2 trial 1027-004, patients with triglyceride levels greater than 200 mg/dL that were treated with gemcabene at 300 mg were observed to have lowered triglycerides by 39% (p<0.001) compared to baseline, and in the same trial in the subset of patients with higher baselines above 500 mg/dL, gemcabene lowered triglycerides by more than 60%.”
The recently issued European patent is expected to provide coverage into 2031. Corresponding patents for gemcabene have also been granted in the United States, Australia, and Mexico with coverage past 2030. These patents are wholly owned by Gemphire.
“Establishing a robust intellectual property estate is a fundamental objective for Gemphire and these patents for gemcabene relating to the SHTG indication strengthen and expand our coverage in one of our three targeted dyslipidemia patient populations,” said Mina Sooch, President and Chief Executive Officer of Gemphire. “Currently available treatments after diet and exercise such as the use of fibrates, prescription fish oils and niacin, are often insufficient in lowering triglyceride levels below 500 mg/dL, and many of these existing treatments do not combine safely with statins.”
Gemphire is initiating a Phase 2b trial, INDIGO-1 in SHTG patients. More information on the trial NCT02944383 can be found at www.clinicaltrials.gov
Gemphire is a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for the treatment of dyslipidemia, a serious medical condition that increases the risk of life threatening cardiovascular disease, and NAFLD/NASH (nonalcoholic fatty liver disease). Please visit www.gemphire.com for more information.
Forward Looking Statements
Any statements in this press release about Gemphire’s future expectations, plans and prospects, including statements about Gemphire’s financial prospects, future operations and sufficiency of funds for future operations, clinical development of Gemphire’s product candidate, expectations regarding future clinical trials and future expectations and plans and prospects for Gemphire and other statements containing the words "believes," "anticipates," "estimates," "expects," "intends," "plans," "predicts," "projects," "targets," "may," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the success and timing of Gemphire’s regulatory submissions and pre-clinical and clinical trials; regulatory developments; changes to Gemphire’s clinical trial designs and regulatory pathways; changes in Gemphire’s capital resource requirements; Gemphire’s ability to obtain additional financing; Gemphire’s ability to successfully market and distribute its product candidate, if approved; Gemphire’s ability to obtain and maintain its intellectual property protection; and other factors discussed in the "Risk Factors" section of Gemphire’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2016, and in other filings Gemphire makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent Gemphire’s views as of the date hereof. Gemphire anticipates that subsequent events and developments will cause Gemphire’s views to change. However, while Gemphire may elect to update these forward-looking statements at some point in the future, Gemphire specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Gemphire’s views as of any date subsequent to the date hereof.
CONTACT: Andrew McDonald, Ph.D. LifeSci Advisors, LLC (646) 597-6987 Jeff Mathiesen, CFO Gemphire Therapeutics Inc. (734)-245-1700