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Potential NASH drug tolerated, did not generate serious adverse events
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In a three-part clinical trial, various doses of aramchol were safe, tolerable and did not produce serious adverse events among healthy volunteers, according to study data released by the drug’s manufacturer.
In a randomized, placebo-controlled study, aramchol (Galmed Pharmaceuticals), a conjugate of cholic acid and arachidic acid indicated for patients with nonalcoholic steatohepatitis who also are obese and have glucose intolerance, was used in 66 healthy male volunteers. In the first two parts of the study, researchers analyzed the pharmacokinetic study of three dosages of aramchol at 200 mg, 400 mg and 600 mg, as well as the safety and tolerability, of the tablets given to patients in single doses after a 10-hour overnight fast or a high-fat, high-calorie meal, according to the release. The third part of the study assessed pharmacokinetic, safety and tolerability of aramchol tablets given in the same three doses 1 hour after a light breakfast for 10 consecutive days.
In the phase 2a clinical trial, aramchol effectively reduced liver fat when taken at 300 mg once daily for 3 months.
“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,” Maya Halperin, MD, chief medical officer at Galmed, said in a press release. “The study results support Galmed’s decision to administer the two higher doses of aramchol in its phase 2b clinical trial in [NASH] patients, which will be conducted in Israel, Latin America and Europe, as well as its phase 2a clinical trial in cholesterol gallstone patients, which was initiated in Israel [recently].”
Despite no serious adverse events occurring, 27 adverse events were experienced by patients; 26 mild and one moderate. Twenty-four of the 27 adverse events were unrelated to aramchol, with the remaining three possibly related, according to the release.
The FDA granted fast track designation to Galmed Pharmaceutical’s aramchol in September.
Galmed will initiate a phase 2b clinical trial of aramchol later this year and will enroll 240 patients with NASH, as well as obesity and insulin resistance, from Israel, Europe and various Latin American countries.
The FDA approved Galmed’s new drug application for aramchol in July.