Gemphire Therapeutics Inc. (GEMP) 10-K Annual Report Tue Mar 20 2018

LIVONIA, Mich., March. 15, 2018 (GLOBE NEWSWIRE) -- Gemphire Therapeutics Inc. (NASDAQ:GEMP), a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for cardiometabolic disorders, including dyslipidemia, non-alcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), today announced its financial results for the quarter and fiscal year ended December 31, 2017, and provided a corporate update.

“2017 was a productive and successful year for Gemphire, with significant progress in our comprehensive Phase 2 program for gemcabene which is designed to show proof of concept in a broad spectrum of cardiometabolic conditions, including hypercholesterolemia, severe hypertriglyceridemia, and NASH,” said Steven Gullans, Ph.D., interim CEO of Gemphire. “Our Phase 2 clinical trials completed in 2017, COBALT-1 and ROYAL-1, both met their primary endpoints, demonstrating that gemcabene is capable of lowering LDL-C, triglycerides and inflammation. In 2018, we expect to make meaningful progress on our remaining Phase 2 trials, including concluding our INDIGO-1 trial in severe hypertriglyceridemia (SHTG) patients in Q2, and enrolling open-label pediatric and adult programs in NAFLD/NASH. In addition, our goal is to advance gemcabene into Phase 3 in dyslipidemia in the second half of 2018, once agreement with the FDA is reached.”

“We are especially excited to have launched our investigation of gemcabene as a potential treatment for NAFLD/NASH with our recently initiated Phase 2 trials in pediatric NAFLD and in familial partial lipodystrophy (FPL),” added Dr. Gullans. “Our decision to move forward in NAFLD/NASH is based on the strong rationale for gemcabene to target the underlying pathology of these diseases. We believe that the drug’s novel mechanism of action, which includes both cardio- and liver-protective properties, together with its favorable safety profile, will provide it with a distinct competitive advantage.”

Fourth Quarter and Recent Corporate Highlights

Completed patient enrollment in Phase 2b INDIGO-1 trial investigating gemcabene in severe hypertriglyceridemia (SHTG) patients.

INDIGO-1 is a 12 week, multicenter, double-blind, placebo-controlled, randomized trial in patients with SHTG (TG ≥ 500mg/dL) with or without background statin therapy.

Patients are enrolled into one of three arms: gemcabene 300 mg, gemcabene 600 mg or placebo once daily.

The primary endpoint is triglyceride (TG) reduction from baseline after 12 weeks.

Company remains on track to report top-line results from the study in the second quarter of 2018.

Launched a Clinical Program to Develop Gemcabene as a Treatment for NASH/NAFLD.

Initiated a Phase 2a proof-of-concept (POC) clinical trial investigating gemcabene as a treatment for pediatric NAFLD. Pediatric NAFLD/NASH is a large and untreated market and provides an opportunity to advance gemcabene in an underserved area with millions of affected patients.

This open label pediatric trial is expected to enroll approximately 40 adolescent children between the ages of 12 and 17 who are diagnosed with NAFLD and abnormal liver function as assessed by liver transaminases. Top line results are expected in early 2019.

The following information was filed by Gemphire Therapeutics Inc. (GEMP) on Thursday, March 15, 2018 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-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Material Contracts, Statements, Certifications & more

Gemphire Therapeutics Inc. provided additional information to their SEC Filing as exhibits

Exhibit 23.1: Consents Of Experts And Counsel

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

Ticker: GEMP
CIK: 1638287
Form Type: 10-K Annual Report
Accession Number: 0001558370-18-002275
Submitted to the SEC: Tue Mar 20 2018 5:28:15 PM EST
Accepted by the SEC: Tue Mar 20 2018
Period: Sunday, December 31, 2017
Industry: Pharmaceutical Preparations

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Gemphire Therapeutics Inc. (GEMP) SEC Filing 10-K Annual report for the fiscal year ending Sunday, December 31, 2017

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