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news.Galmed Pharmaceuticals has announced the completion of the statistical analysis of a pharmacokinetic (PK) study of three doses, including two high doses (400mg and 600mg), of its drug candidate, aramchol, in 66 healthy adult male volunteers.
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No Serious Adverse Events (SAEs) were observed in the study.
Galmed’s Chief Medical Officer, Dr. Maya Halperin stated, "The completion of the analysis adds important data to the favorable safety profile of aramchol, which we’ve consistently observed in our earlier clinical trials, as well as in our long-term, high dose animal toxicology studies."
Dr. Halperin continued, "The study results support Galmed’s decision to administer the two higher doses of aramchol in its Phase IIb clinical trial in Non-Alcoholic Steato-Hepatitis (NASH) patients, which will be conducted in Israel, Latin America and Europe, as well as its Phase IIa clinical trial in cholesterol gallstone patients, which was initiated in Israel earlier this month."
The study was a single-site, randomized, partially double-blind, placebo-controlled study conducted in three parts. The first two parts of the study assessed PK, safety and tolerability of aramchol tablets administered in single doses of 200 mg, 400mg and 600mg either following a ten-hour overnight fast or a high-fat, high-calorie meal.
The third part of the study assessed PK, safety and tolerability of aramchol tablets administered in the same three doses as the first two parts of the study for ten consecutive days, in each case within one hour after a light breakfast.
Although no SAEs were observed, a total of 27 adverse events were observed (26 mild and one moderate). Out of the 27 adverse events, 24 were considered as unrelated to aramchol and three as possibly related (all three of which were mild).
The PK data gathered by Galmed from the three parts of the study revealed that aramchol is appropriate for a once daily oral administration with food.
As previously disclosed, Galmed is currently prepared to initiate its Phase IIb trial of aramchol in NASH patients as scheduled, which, if successful, may serve as a basis for Phase III pivotal trials for the treatment of NASH to be conducted in the United States and Europe.
Galmed expects to report interim results of this Phase IIb trial in the second half of 2015, and final results in the second half of 2016.