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Gemphire Therapeutics Provides Clinical Update

Thursday, January 5, 2017   (0 Comments)
Posted by: Kate Oesterle
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Enrollment in the ROYAL-1 Clinical Trial Investigating Gemcabene in Hypercholesterolemia Is Ahead of Plan and Expected to be Completed This Month – Data Expected in the Third Quarter of 2017


Interim Data from the COBALT-1 Trial for Homozygous Familial Hypercholesterolemia (HoFH) Patients Expected the Week of January 30, 2017

INDIGO-1 Trial Commenced for Severe Hypertriglyceridemia (SHTG) Patients


LIVONIA, Mich., Jan. 05, 2017 (GLOBE NEWSWIRE) -- Gemphire Therapeutics Inc. (NASDAQ:GEMP), 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 diseases, and nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH), today provided the following update on the Company’s three clinical trials for its product candidate, gemcabene:

  • Enrollment is greater than 90% complete toward the target enrollment of 104 patients in Gemphire’s ROYAL-1 Phase 2b trial designed to investigate gemcabene in the treatment of patients with hypercholesterolemia not adequately controlled on high-intensity or moderate-intensity stable statin therapy.  Due to the faster than expected enrollment, Gemphire now expects to complete enrollment in January and release top line data from ROYAL-1 trial in the third quarter of 2017.  The Company believes the rapid enrollment may be a reflection of the large unmet need for additional LDL-C lowering in cardiovascular patients not at goal even on intense statin therapy and/or ezetimibe.   
  • Gemphire expects to announce interim results for its open-label COBALT-1 trial investigating gemcabene in patients with clinically diagnosed HoFH during the week of January 30, 2017.
  • Gemphire commenced its Phase2b INDIGO-1 trial in SHTG patients in December 2016 with a successful Investigators’ Meeting representing over 30 clinical sites, followed by the first SHTG patient pre-screened.  The Company expects to report top-line results from INDIGO-1 in the fourth quarter of 2017.

“Early completion of enrollment in the ROYAL-1 trial in hypercholesterolemia patients will be an important accomplishment in the clinical development of gemcabene.  We are very encouraged by the high level of interest shown by both patients and physicians in gemcabene, our novel, once-daily, oral therapy, and are pleased the trial is expected to be fully enrolled in only two months,” said Mina Sooch, President and Chief Executive Officer of Gemphire.  “The patient groups that have been enrolled in ROYAL-1 represent a large market of approximately 10 million patients in the U.S. alone that are currently unable to effectively manage their dyslipidemia despite current statin and ezetimibe therapies.”


Read full article here.

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