TORONTO, Canada I January 16, 2015 I Antibe Therapeutics Inc. (TSXV:ATE; OTCQX:ATBPF) today announced that it has suspended development of its lead drug, ATB-346, due to safety concerns encountered in its Phase I clinical trial.
Safety concerns centered on the finding of significant liver enzyme elevations in one subject in the highest dose cohort. Additional liver enzyme elevations were observed in other subjects in the higher dose cohorts. Antibe is concerned that, when assessed together, these liver enzyme elevations are indicative of potential hepatotoxicity.
“Our primary concern is with the health of the subjects,” said Dan Legault, Antibe’s CEO. “We are very disappointed by these unexpected findings and will fully assess our options moving forward.”
Pre-clinical studies on ATB-346 provided no indication of potential hepatotoxicity. The company continues to collect and assess data and will report back to the scientific community and the market with further details on its data review and corporate strategy as appropriate.
About Antibe Therapeutics Inc.
Antibe develops safer medicines for pain and inflammation. Antibe’s technology involves linking a hydrogen sulfide-releasing molecule to an existing drug to produce a patented, improved medicine. Antibe’s lead drug ATB-346 targets the global need for a safer non-steroidal anti-inflammatory drug (NSAID) for chronic pain and inflammation. ATB-352, the second drug in Antibe’s pipeline, targets the urgent global need for a safer analgesic for severe acute pain.
SOURCE: Antibe Therapeutics
Post Views: 105
TORONTO, Canada I January 16, 2015 I Antibe Therapeutics Inc. (TSXV:ATE; OTCQX:ATBPF) today announced that it has suspended development of its lead drug, ATB-346, due to safety concerns encountered in its Phase I clinical trial.
Safety concerns centered on the finding of significant liver enzyme elevations in one subject in the highest dose cohort. Additional liver enzyme elevations were observed in other subjects in the higher dose cohorts. Antibe is concerned that, when assessed together, these liver enzyme elevations are indicative of potential hepatotoxicity.
“Our primary concern is with the health of the subjects,” said Dan Legault, Antibe’s CEO. “We are very disappointed by these unexpected findings and will fully assess our options moving forward.”
Pre-clinical studies on ATB-346 provided no indication of potential hepatotoxicity. The company continues to collect and assess data and will report back to the scientific community and the market with further details on its data review and corporate strategy as appropriate.
About Antibe Therapeutics Inc.
Antibe develops safer medicines for pain and inflammation. Antibe’s technology involves linking a hydrogen sulfide-releasing molecule to an existing drug to produce a patented, improved medicine. Antibe’s lead drug ATB-346 targets the global need for a safer non-steroidal anti-inflammatory drug (NSAID) for chronic pain and inflammation. ATB-352, the second drug in Antibe’s pipeline, targets the urgent global need for a safer analgesic for severe acute pain.
SOURCE: Antibe Therapeutics
Post Views: 105
