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Gemphire Therapeutics stops study of liver disease drug

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Gemphire Therapeutics stops study of liver disease drug

Livonia, Mich.-based Gemphire Therapeutics Inc. said it was stopping a study of its medicine gemcabene in children with non-alcoholic fatty liver disease.

The company had initiated a phase 2a study of the drug earlier this year to determine whether it could be used to treat the condition in that particular patient population.

However, the study's data and safety monitoring board at the Emory University School of Medicine found that the first three patients who received 12 weeks of treatment saw an increase in their liver fat content — indicating their disease was worsening.

The investigator believed that the unexpected problem was likely due to the therapy and recommended that the trial be stopped. Other patients enrolled in the trial have now been taken off the treatment and Gemphire is currently scheduling early termination visits.

The monitoring board also recommended follow-ups of the subjects to gather safety data.

Gemcabene has been given to about 1,200 adults across multiple phase 1 and 2 studies for up to 12 weeks with no drug-related serious side effects, Gemphire CEO Steven Gullans said in a news release.

The therapy is also being studied in a phase 2a trial for treating certain patients with familial partial lipodystrophy — a rare genetic disorder characterized by an abnormal distribution of fatty tissue.

Gemcabene also met its main goal in a phase 2b study for treating patients with severe hypertriglyceridemia, a common cause of acute pancreatitis and coronary artery disease.