Gemphire Therapeutics Inc. (NASDAQ: GEMP) shares more than doubled early on Thursday after the company announced results from its midstage trial. Specifically, these are results from its Phase 2b INDIGO-1 trial in severe hypertriglyceridemia (SHTG).
Ultimately, the study met the primary endpoint with median triglycerides (TGs) significantly decreased by 47% in gemcabene (600 mg) treated patients compared to 27% for placebo-treated patients. Also, 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 at the end of the study.
Statistically significant secondary endpoints achieved with 600 mg gemcabene, including placebo-corrected median decreases in LDL-C (24%), non-HDL-C (16%), VLDL-C (19%), apoB (12%), apoE (14%), apoCIII (11%) and SAA (23%).
Overall the INDIGO-1 results further support Gemphire’s rationale for developing gemcabene as a treatment for nonalcoholic fatty liver disease/nonalcoholic steatohepatitis.
Dr. Steven Gullans, CEO of Gemphire, commented:
We are pleased to reach this milestone of meeting both primary and multiple secondary endpoints and look forward to advancing gemcabene into Phase 3 trials. There are approximately 3.5 million SHTG patients in the United States in need of lowering their TG levels below 500 mg/dL to reduce their risk of developing acute pancreatitis. Our once daily tablet has demonstrated promising evidence of safety, efficacy and tolerability in more than 1,100 subjects thus far. Moreover, in prior studies 600 mg of gemcabene reduced LDL-C, hsCRP and other biomarkers that are typically elevated in a broad range of dyslipidemic conditions.
Shares of Gemphire traded more than 101% higher early Friday, at $10.56 in A a 52-week range of $4.75 to $21.59. The consensus analyst price target is $23.60.