Antibe Places AME Study Of Otenaproxesul On Pause Due To Pre-specified Safety Threshold Exceeded

(RTTNews) - Antibe Therapeutics Inc. (ATE.TO, ATBPF.OB) said it has placed its absorption, metabolism and excretion or "AME" study of otenaproxesul on a required pause because a pre-specified safety threshold was exceeded.

The study is one of several nonclinical and clinical studies being conducted in advance of otenaproxesul's planned Phase III program.

The AME study had enrolled a total of 42 subjects on either a 75 mg or 100 mg daily dose of otenaproxesul, of whom 35 had completed the 28-day drug administration period, with seven subjects having been administered the drug for 21 days.

Three subjects in the 100 mg cohort, who had completed the full drug administration period, exhibited liver transaminase elevations exceeding five times the upper limit of normal, triggering the required pause. Other indicators of liver function for these subjects were normal.

The study incorporates an in-clinic post-administration observation period of 14 days, which is continuing. Although the treatment duration was longer than in previous Antibe studies, these observations were unexpected given the results of efficacy, safety and pharmacokinetic studies conducted to date, the company said.

The company said it will continue to collect and analyze additional data over the next several weeks to understand the cause and implications of these events and to determine the optimal plan for the continued development of otenaproxesul.