TORONTO– Antibe Therapeutics Inc. (TSX: ATE, OTCQX: ATBPF), a clinical stage company leveraging its unique hydrogen sulfide platform to develop safer medicines for pain and inflammation, has placed its absorption, metabolism and excretion (“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 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. In parallel, Antibe will discuss the status of the AME study and the development path going forward with Health Canada. The Company will update its shareholders once this work is complete.
Patient safety is paramount to Antibe in developing clinically relevant and novel medicines to control pain and inflammation. As the AME study was designed in part to identify doses for the initial Phase III trial, these findings indicate that further research is warranted with respect to both the optimal dose range and potential improvements to the formulation. These efforts will impact the plan for the Phase III program.
Supported by a strong team and a $66 million cash position, Antibe is also continuing to advance the development of its pipeline of other novel drug candidates for pain and inflammation.
