TORONTO, CANADA — (June 3, 2019) – Antibe Therapeutics Inc. (“Antibe” or the “Company”) (TSXV: ATE, OTCQB: ATBPF), a leader in developing safer therapeutics for pain and inflammation, is pleased to announce the lead indication for its second pipeline drug, ATB-352, a potent and non-addictive analgesic for the treatment of severe pain. The Company will be targeting post-operative pain as the lead indication for ATB-352, a US$9 billion market that is in desperate need of safer and non-addictive therapies.
“The availability of safe and effective non-opioid therapies for post-operative pain is limited and represents a clear unmet medical need,” remarked Dan Legault, Antibe’s CEO. “Post-operative pain is an ideal indication for ATB-352 given its analgesic potency, gastrointestinal safety and lack of abuse potential. This program has the potential to unlock tremendous value for shareholders, while offering a possible solution to the escalating opioid overdose crisis.”
In the United States, there are 50 million surgical procedures annually that require post-operative pain medication. A total of 80% of patients undergoing surgery are prescribed opioids, and as many as 6.5% become persistent opioid users after surgery. According to Centers for Disease Control and Prevention, 130 Americans die every day from an opioid overdose.
Many surgeries require a multi-day recovery period in the hospital during which time intravenous agents are often prescribed to manage post-operative pain. Upon discharge, however, patients may still suffer from pain for several weeks. This transition can be challenging for both patients and physicians, who seek to prescribe an oral regimen that is effective but does not increase safety concerns. Antibe will be pursuing a step-down therapeutic strategy for ATB-352 to streamline post-operative pain management, specifically: (i) an aqueous formulation for post-operative intravenous administration in the hospital; and (ii) a tablet formulation for short-term use after hospital discharge.
The Company plans to pursue a Fast Track designation with the FDA to expedite the development and regulatory approval process for ATB-352.
ATB-352 is a hydrogen sulfide-releasing derivative of ketoprofen, one of the most potent nonsteroidal anti-inflammatory drugs (“NSAIDs”) commonly prescribed for acute pain. However, ketoprofen is also one of the most damaging NSAIDs to the gastrointestinal (“GI”) tract. ATB-352 has been shown to be GI-safe and non-addictive in animal studies, a key finding that was confirmed by its inability to bind to opioid receptors. IND-enabling pre-clinical studies for ATB-352 are underway.
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
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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