TORONTO, ONTARIO — (January 16, 2015) — 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 drug for chronic pain and inflammation. ATB-352, the second drug in Antibe’s pipeline, targets the urgent global need for a safer, non-addictive analgesic for treating severe acute pain, while ATB-340 is a GI-safe derivative of aspirin. www.antibethera.com
Antibe’s subsidiary, Citagenix Inc. (“Citagenix”), is a leader in the sales and marketing of tissue regenerative products servicing the orthopedic and dental marketplaces. Since its inception in 1997, Citagenix has become an important source of knowledge and experience for bone regeneration in the Canadian medical device industry. Citagenix is active in 15 countries, operating in Canada through its direct sales teams, and internationally via a network of distributor partnerships. www.citagenix.com
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
This news release includes certain forward-looking statements, which may include, but are not limited to, the growth of product sales, engaging new distributors and independent representatives, the completion of financing transactions and the licensing and development of drugs and medical devices. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “will”, “anticipate”, “believe”, “plan”, “estimate”, “expect”, “intend”, “propose” and similar expressions. Forward-looking statements involve known and unknown risks and uncertainties that could cause actual results, performance, or achievements to differ materially from those expressed or implied in this news release. Factors that could cause actual results to differ materially from those anticipated in this news release include, but are not limited to, the Company’s ability to secure additional financing, its inability to execute its business strategy and successfully compete in the market, and risks associated with drug and medical device development generally. Antibe Therapeutics Inc. assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those reflected in the forward-looking statements except as required by applicable law.
Antibe Therapeutics Inc.
Chief Executive Officer
Tel: +1 416-473-4095
Read all news