Shares of Gemphire Therapeutics Inc (NASDAQ:GEMP) dove sharply lower Friday after the biopharmaceutical group reported that a Phase 2a trial evaluating its drug gemcabene in pediatric patients with non-alcoholic fatty liver disease was terminated due to “unanticipated problems.”
The data and safety monitoring board at Emory University’s School of Medicine overseeing the trial recommended calling it quits on the late-stage study, citing trial participants’ poor reactions to the drug.
The announcement prompted a 54% drop in Gemphire’s shares, which fell to US$1.50, in Friday's pre-market session.
Indeed, data on the first three patients who underwent 12 weeks of treatment as part of the study showed that all three experienced an increase in liver fat content, which was deemed an “unexpected problem” by the trial investigator as it demonstrated that the disease was worsening.
The other patients taking part in the trial, which began early in the year, have now been taken off of gemcabene.
Emory’s Data and Safety Monitoring Board will provide Gemphire with a report of their examination of the trial’s failure once patient results have been analyzed.
In response to the setback, Dr. Steven Gullans, Gemphire’s CEO, noted that gemcabene has been given to nearly 1,200 adults across 25 Phase 1 and Phase 2 trials for up to twelve weeks with no drug-related serious adverse events reported.
“We remain confident that gemcabene has the potential to be an effective therapy for a host of cardiometabolic patients and we intend to continue to develop gemcabene to address multiple indications,” Gullans said in a statement.
Gemphire, which is headquartered in Livonia, Michigan, focuses on developing therapies for patients with dyslipidemia or abnormally high levels of lipids in the blood, as well as treatments for two serious liver diseases - non-alcoholic fatty liver disease and non-alcoholic steatohepatitis.
Contact Ellen Kelleher at [email protected]