Gemphire Therapeutics (NASDAQ: GEMP) shares are down 45% to USD 1.80 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 Company said the data and safety monitoring board at Emory University overseeing the trial recommended the termination. Gemphire said data on the first three patients undergoing 12 weeks of treatment all experienced an increase in liver fat content, which was deemed an unexpected problem.
"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," said Chief Executive Officer Steven Gullans.
Gemphire also announced on Tuesday it would delay its licensing arrangement with Pfizer Inc. (NYSE: PFE) for gemcabene. The new agreement permits Pfizer to pull out of the license agreement if the first commercial sale of the drug hasn’t occurred by April of 2024, which is three years later than the date previously agreed to.
“The extension to the agreed date by which we need to commercialize gemcabene provides us with additional flexibility to focus on the optimal development path and timeline for gemcabene,”Gullans said in a statement.
Gemphire’s cash balance at June 30th, 2018 was USD 28 Million and management believes that, based on current projections and taking into account the delay of significant cash expenditures for clinical trials and manufacturing, it will be sufficient to fund the Company’s operations into the fourth quarter of 2019.