Gemphire Therapeutics Inc. (NASDAQ: GEMP) vaulted Friday after the company disclosed that Gemcabene met primary and secondary endpoints in INDIGO-1 study.
The company, based in Livonia, Michigan, is a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for cardiometabolic disorders, including dyslipidemia and nonalcoholic steatohepatitis (NASH). Today, it announced that it achieved the primary endpoint, reduction of TGs by gemcabene, in its Phase 2b INDIGO-1 trial in SHTG patients with baseline serum TGs >500 mg/dL.
Among the key findings were 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%), SAA (23%); (p-values <0.05; ranked ANCOVA).
No severe adverse events (SAEs) were observed with gemcabene and adverse events (AEs), which were generally mild to moderate, occurred less frequently with gemcabene than placebo.
Said CEO Steven Gullans. "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 in the company jumped $5.32, or 101.5%, to $10.56.
Related Stories
