Blog Exposure – Gemphire Therapeutics Launches Clinical Program for Developing Gemcabene as Treatment for NASH/NAFLD

LONDON, UK / ACCESSWIRE / December 26, 2017 / Active-Investors.com has just released a free research report on Gemphire Therapeutics Inc. (NASDAQ: GEMP). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=GEMP as the Company’s latest news hit the wire. On December 21, 2017, the Company announced the launch of a clinical program to develop its drug candidate – Gemcabene – as a treatment option for NASH/non-alcoholic fatty liver disease (NAFLD). An Investigational New Drug (IND) application has been opened by the Company for non-alcoholic steatohepatitis (NASH). Register today and get access to over 1000 Free Research Reports by joining our site below:

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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Gemphire Therapeutics most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:

www.active-investors.com/registration-sg/?symbol=GEMP

This program is where the Company will start the Phase-IIa proof-of-concept (POC) clinical trials in adult candidates with FPL (familial partial lipodystrophy). FPL is a rare genetic disorder and orphan disease where patients have an abnormal distribution of fatty (adipose) tissue, which can lead to a variety of metabolic abnormalities including NASH.

Commenting on the launch of the Phase-IIa clinical program, Dr. Steven Gullans, Interim CEO of Gemphire, said:

“We are very pleased to initiate this clinical trial as the first step in our plan to develop Gemcabene as a highly differentiated treatment for NASH. As the only compound in development that targets the triple threat of LDL-C, inflammation and triglycerides (TG) – addressing the full spectrum of dyslipidemia – we believe Gemcabene has potential to be highly effective in this adult population, which is burdened by multiple cardiometabolic risk factors.”

About Phase-IIa POC clinical trial

The Company is confident about the success of its clinical program as it is based on the strong preclinical data and scientific rationale that support the use of Gemcabene for treatment of NASH. Gemcabene has a novel action mechanism which the Company believes has a significant potential to establish the effects of the drug on established measures of NASH that can also be evaluated in FPL patients. Additionally, that Company plans to launch the second part of the Phase-IIa POC trials in NASH in Q1 2018. The aim of these trials is to make way for confirmatory trials in a broader NASH population.

The Phase-IIa POC clinical trial is aimed at measuring NASH-related endpoints in FPL. The main objective of these trials is to evaluate the efficacy and safety of two dosing regimens of Gemcabene in up to eight FPL patients with elevated TG (triglycerides) and NAFLD. When entering the trials, the candidates must have a fasting TG value ≥ 250 mg/dL and quantifiable steatosis (stage 2 or 3) while on a stable, low-fat, low-cholesterol diet. After which they will be split into two random groups for treatment where they will either receive a dosage of Gemcabene 300 mg once daily for 24 weeks or a dosage of Gemcabene 300 mg once daily for 12 weeks. This will immediately be followed by a dosage of Gemcabene 600 mg once daily for a further 12 weeks.

The endpoint of the clinical trial is the reduction in TG after 12 weeks of treatment. The second endpoint is to include measures of liver fat (MRI-PDFF) and NAS (histology) at 24 weeks. Those patients who respond to the treatment and show TG lowering > 30% at Week 12, will have a chance to enter a separate long-term therapy with Gemcabene. The Company is expecting to meet its endpoint and share the results in H2 2018.

Rationale for Going ahead with Gemcabene clinical trials

The Company’s decision to move forward with Gemcabene is mainly because of this novel mechanism of action in NASH. Gemcabene has both liver- and cardio-protective properties. Gemcabene’s compound targets the pathology of the disease and has the potential to add complementary mechanisms that lower both TG (fat) and inflammation. The Company has compiled data on Gemcabene from over 950 subjects across 20 completed trials. The studies also show that subjects treated with oral, once-daily Gemcabene, have significant lowering in plasma of atherogenic particles, TG and CRP (a measure of inflammation). Gemcabene has also demonstrated a doubling of mean increase in glucose disposal rate compared to placebo suggesting potential effects on insulin sensitivity.

The data shows that Gemcabene is well tolerated and does not show any liver toxicities at doses between 150 mg to 900 mg for up to 12 weeks. the data also indicated that Gemcabene has a low likelihood for drug-drug interactions, particularly with statins. This is crucial since statins are widely used in diabetic and dyslipidemic patients, the underlying conditions associated with NASH. Gemcabene’s safety profile indicated that it has a competitive advantage in the treatment of NASH/NALFD.

About Familial Partial Lipodystrophy

FPL is a rare genetic disorder and an orphan disease characterized by an abnormal distribution of fatty (adipose) tissue. As the body is unable to store fat correctly, a build-up can occur around all vital organs and in the blood (hypertriglyceridemia). FPL can also cause an abnormal build-up of fats in the liver (hepatic steatosis), which can result in an enlarged liver (hepatomegaly) and abnormal liver function. FPL can lead to loss of metabolic control and a variety of metabolic abnormalities including diabetes, cardiovascular disease, hypertriglyceridemia and NASH. At present there is no FDA approved treatment for FPL Lipodystrophy United, an organization with the mission to provide an interactive community, facilitate support and education for anyone affected by this rare disease is supporting this potential treatment.

About NAFLD/NASH

NASH is a severe disease of the liver caused by inflammation and a build-up of fat in the organ. It is estimated that approximately 2% to 5% of the adult population in US is affected by NASH. In addition, another 10% to 30% of the population has fat in their liver, but no inflammation or liver damage, this condition is called NAFLD or “fatty liver”. The factors causing NASH are unclear, however, the condition occurs in middle-aged and overweight or obese people. Progression of NAFLD/NASH can lead to liver cirrhosis, fibrosis, hepatocellular carcinoma, liver failure, and liver-related death. Currently, there are no FDA approved treatments for NAFLD/NASH.

About Gemcabene

The Company’s drug candidate Gemcabene is a first-in-class, once-daily, oral therapy for patients who are unable to achieve normal levels of LDL-C or triglycerides with currently approved therapies, primarily statins. The unique feature of Gemcabene is its mechanism of action and safety profile, which are highly differentiated from other clinical candidates. Gemcabene’s mechanism of action (MOA) is designed to enhance the clearance of very low-density lipoproteins (VLDLs) in the plasma and inhibition of the production of cholesterol and triglycerides in the liver. Gemcabene has demonstrated POC efficacy for NASH in the rodent STAM™ model developed at SMC Laboratories in Tokyo, Japan. Gemcabene has been tested as monotherapy and in combination with statins and other drugs in 956 subjects across 20 Phase-1 and Phase-2 clinical trials. Given the above efficacy and safety and tolerability profile, Gemcabene has potential for treatment of humans, especially when used as an add-on to several other therapeutic drugs.

About Gemphire Therapeutics Inc.

Livonia, Michigan based Gemphire is a clinical-stage biopharmaceutical Company focused on developing and commercializing therapies for the treatment of dyslipidemia and NASH. The Company is focused on providing new treatment options for cardiometabolic diseases through its complementary, convenient, cost-effective product candidate Gemcabene as add-on to the standard of care, especially statins, that will benefit patients, physicians, and payors.

Stock Performance Snapshot

December 22, 2017 – At Friday’s closing bell, Gemphire Therapeutics’ stock advanced 3.30%, ending the trading session at $8.13.

Volume traded for the day: 25.63 thousand shares.

Stock performance in the last twelve-month period – up 2.39%; and year-to-date – up 3.70%

After last Friday’s close, Gemphire Therapeutics’ market cap was at $83.74 million.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry.

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