Gemphire Therapeutics Announces Presentation at ACC Meeting of Phase 2 Clinical Trial Investigating Effect of Gemcabene on Insulin Sensitization
"We are very encouraged by the meaningful effects on both the glucose disposal rate and LDL-C reduction in this study showcasing the differentiated cardiometabolic effects of gemcabene," said
The primary efficacy endpoint was insulin sensitivity as defined by average GDR (mg/kg per min) during the last 30 minutes of the 3-hour euglycemic hyperinsulinemic clamp study. An increase in the GDR suggests an improvement in insulin function. The percentage change from baseline in the GDR was compared for the placebo and 900 mg gemcabene group using a 2-sample t-test. Additionally, a post-hoc analysis was performed on mean percent change in LDL-C, total cholesterol (TC), TGs and GDR using a paired t-test.
Gemcabene was associated with a doubling of 13% mean increase in GDR compared to a 6.8% increase for placebo. Although statistical significance was not observed in the pre-specified analysis, a post-hoc analysis more applicable to the size of this study showed a statistically significant change from baseline to Day 29 in GDR for gemcabene 900 mg (p<0.0178) versus a non-significant effect for placebo.
In addition, gemcabene 900 mg lowered LDL-C by 40% (p<0.0001) and TC by 27% (p<0.0001) consistent with past results in hypercholesterolemic subjects. Gemcabene was generally well-tolerated. There were no deaths, serious adverse events, or withdrawals due to adverse events during the study.
“The current clinical study was conducted in response to preclinical studies that showed increased insulin sensitivity in mouse 3T3 L1 adipocytes and obese diabetic rats by gemcabene,” said
To view the poster, please refer to the “Publications and Presentations” section of the company’s website at www.gemphire.com.
About Gemcabene
Gemphire’s product candidate, gemcabene (CI-1027), is a first-in-class, once-daily, oral therapy that may be suitable for patients who are unable to achieve normal levels of LDL-C or triglycerides with currently approved therapies, primarily statins. Gemcabene's mechanism of action is designed to enhance the clearance of very low-density lipoproteins (VLDLs) in the plasma and inhibit the production of cholesterol and triglycerides in the liver. The combined effect for these mechanisms has been clinically observed to result in a reduction of plasma VLDL-C, LDL-C, and triglycerides. In addition, gemcabene has been shown to markedly lower C-reactive protein. Gemcabene is liver-directed and reduces apoC-III mRNA and plasma levels. Gemcabene also reduces acetyl-CoA carboxylase (ACC) and CCR2/CCR5 receptor mRNA levels, which may have applications in non-alcoholic steatohepatitis (NASH)/non-alcoholic fatty liver disease (NAFLD). Gemcabene has demonstrated proof of concept efficacy in the STAMTM model for NASH developed at
About Gemphire
Gemphire is a clinical-stage biopharmaceutical company that is committed to helping 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 as add-on to the standard of care especially statins that will benefit patients, physicians, and payors. Gemphire has initiated 3 clinical trials for homozygous familial hypercholesterolemia (HoFH), heterozygous familial hypercholesterolemia (HeFH)/atherosclerotic cardiovascular disease (ASCVD), and severe hypertriglyceridemia (SHTG) under NCT02722408, NCT02634151, and NCT02944383, respectively with a fourth planned trial in NASH. 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, expectations regarding operating expenses and cash used in operations, and other statements containing the words "believes," "anticipates," "estimates," "expects," "intends," "plans," "predicts," "projects," "targets," "may," "potential," "will," "would," "could," "should," "continue," “scheduled” 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 requirements or 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 Annual Report on Form 10-K for the period ended
Contact:Andrew McDonald , Ph.D.LifeSci Advisors, LLC (646) 597-6987Jeff Mathiesen , CFOGemphire Therapeutics Inc. (734)-245-1700