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news.Arete Therapeutics, a developer of small molecule drugs, has announced positive topline Phase I results for AR9281, an orally-administered soluble epoxide hydrolase inhibitor for the treatment of metabolic syndrome. The results of the multi-dose study demonstrate that AR9281 was safe and well tolerated in healthy volunteers.
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The Phase I single-center, multiple ascending dose study tested the safety, tolerance and pharmacodynamics of AR9281 in 24 healthy male and female volunteers. Participants were enrolled in three cohorts, evaluating doses up to 1200mg/day of AR9281 for seven consecutive days.
According to the company, all doses of the drug were well tolerated and no dose-related adverse events were observed. As part of the pharmacodynamic assessment, levels of s-EH activity were measured after day one of the trial and confirmed 100% inhibition of the target in all subjects receiving 1200mg of AR9281.
James Sabry, president and CEO of Arete Therapeutics, said: “We are extremely pleased with the results of this trial, which show that AR9281, a first-in-class soluble epoxide hydrolase (s-EH) inhibitor, produces a dose-dependent inhibition of blood s-EH activity, and is safe and well-tolerated in healthy volunteers.
“In the first quarter of 2009, we will initiate a Phase IIa clinical trial with AR9281, a compound we believe has the potential to become a new alternative for patients with metabolic syndrome.”