Epygenix Therapeutics Inc, a privately held biopharmaceutical company, has completed a phase one placebo controlled double blind two period study to evaluate the safety and pharmacokinetics of escalating single and multiple oral doses of EPX-100 in fasting healthy subjects and following a high-fat meal, it was reported on Friday.
The company says that this Phase one study confirmed that the product is safe, well-tolerated, and does not show any clinically significant abnormalities among equal numbers of male and female subjects (N=12 each). Pharmacokinetics were dose-proportional and consistent with preclinical animal studies.
The company is to start EPX-100 Phase two efficacy studies with Dravet Syndrome patients in the United States and Australia based on results from this Phase one study. It is preparing these clinical studies with the team at Greenlight Clinical.
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