Antibe Therapeutics Inc. (TSX: ATE) shared today that it is putting on pause the absorption, metabolism, and excretion study of its osteoarthritis pain treatment lead candidate otenaproxesul. This follows after the clinical study exceeded the pre-specified safety threshold.
The study is part of the drug candidate’s Phase III trial involving 42 subjects. Three of the subjects who were administered 100mg of otenaproxesul exhibited liver transaminase elevations exceeding five times the upper limit. The company, however, noted that other indicators of liver function for these subjects were normal.
These elevations were discovered during the 14-day in-clinic post-administration observation period for subjects who have completed the full drug administration period. Antibe relayed that these observations were unexpected based on the efficacy, safety, and pharmacokinetic studies previously conducted on the drug.
The firm said it plans to discuss the status of the paused study and its outlook with Health Canada.
Antibe Therapeutics last traded at $3.39 on the TSX.
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