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Last10K.com | 10-Q Quarterly Report Mon Nov 13 2017
Exhibit 99.1
Gemphire Therapeutics Presents Data at American Heart Association (AHA) Scientific Sessions Showing that Gemcabene Significantly Reduces Atherogenic Remnant Lipoprotein and LDL-C as Add-on to Statins in a Cardiometabolic Population and Reports Third Quarter 2017 Financial Results
Gemcabene reduced LDL-C by 20% and hsCRP by 53% when added to moderate intensity statin therapy
In cardiometabolic patients gemcabene improves atherogenic burden and reduces inflammation
LIVONIA, Mich., November 13, 2017 Gemphire Therapeutics Inc. (NASDAQ: GEMP), a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for cardiometabolic disorders, including dyslipidemia and NASH, today announced the presentation of preclinical and clinical study results, its financial results for the three and nine month periods ended September 30, 2017, and provided a corporate update. The study results were featured in poster presentations Sunday November 12th and today at the American Heart Association® (AHA) in Anaheim, California.
“The third quarter of 2017 was marked by great progress in advancing gemcabene in dyslipidemia and NASH,” said Steven Gullans, Ph.D., interim CEO of Gemphire. “ROYAL-1 was the second of two recent Phase 2b studies to successfully meet its primary endpoint, and new data from ROYAL-1 presented at the American Heart Association meeting have given us further insights into gemcabene’s benefits to patients. We are now preparing for end of Phase 2 meetings for the hypercholesterolemia indications with the FDA and EMA and anticipate that these will take place early in 2018, with the goal of reaching agreement on the overall design of the planned Phase 3 development program. We are also moving forward in NASH, and plan to begin a Phase 2 trial before year end 2017.”
American Heart Association Scientific Sessions 2017
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Final results for ROYAL-1 Clinical Data: Gemcabene Add-on Therapy to High- and Moderate-Intensity Statin Stratums in Hypercholesterolemic Patients |
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Greater effects were observed in a cardiometabolic population, patients with mixed dyslipidemia, who have a particularly high atherogenic particle burden. In the mixed dyslipidemia group of patients, gemcabene 600 mg demonstrated a placebo adjusted LDL-C reduction of 23% (p < 0.05). |
The following information was filed by Gemphire Therapeutics Inc. (GEMP) on Monday, November 13, 2017 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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Gemphire Therapeutics Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2017 10-K Annual Report includes:
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Gemphire Therapeutics Inc. provided additional information to their SEC Filing as exhibits
Ticker: GEMP
CIK: 1638287
Form Type: 10-Q Quarterly Report
Accession Number: 0001558370-17-008803
Submitted to the SEC: Mon Nov 13 2017 9:04:06 AM EST
Accepted by the SEC: Mon Nov 13 2017
Period: Saturday, September 30, 2017
Industry: Pharmaceutical Preparations
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