Gemphire Therapeutics Inc. (GEMP) SEC Filing 10-Q Quarterly report for the period ending Saturday, June 30, 2018

·

Announced gemcabene achieved its primary endpoint in the Phase 2 INDIGO-1 study of severe hypertriglyceridemia (SHTG) patients (> 500 mg/dL)

o

Primary endpoint met with median triglycerides (TG) significantly decreased by 47% in gemcabene 600 mg group compared to 27% for placebo (P=0.0063; ranked ANCOVA).

o

The clinical target for SHTG patients is to reach a serum TG level of less than 500 mg/dL. The 600 mg gemcabene group attained a significantly lower median level of serum TGs of 333 mg/dL compared to placebo of 538 mg/dL (P=0.0137) at the end of the study. 

o

Multiple secondary endpoints achieved with 600 mg gemcabene, including placebo-corrected median decreases in LDL-C, non-HDL-C, VLDL-C, apoB, apoE, apoCIII and SAA.

o

Adverse events (AEs) were generally mild to moderate, occurring less frequently with gemcabene than placebo. No severe adverse events (SAEs) were observed with gemcabene.

·

Appointed Steven Gullans, Ph.D., as President and Chief Executive Officer. Dr. Gullans served as Interim President and Chief Executive Officer of Gemphire from May 2017 to May 2018.

·

U.S. Food and Drug Administration (FDA) requested that the Company produce data from a sub-chronic toxicology study to support lifting the partial clinical hold on gemcabene with respect to clinical trials of longer than six months in duration.

o

The Company is working with the FDA to release the partial hold, with the goal of proceeding to an End of Phase 2 meeting and reaching an agreement on the design of a Phase 3 clinical program in dyslipidemia.  It plans to conduct the studies required by the FDA and expects to submit the additional results in the second quarter of 2019.

o

The Company continues to be free to conduct clinical trials with gemcabene that do not extend beyond six months in duration.

·

The investigator-led open label Phase 2a proof-of-concept trial evaluating gemcabene in pediatric NAFLD was terminated due to unexpected liver problems observed in the patients that underwent 12-week MRI-PDFF imaging scans.