TORONTO--(BUSINESS WIRE)--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.
About 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,
non-addictive 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-addictive drug for
chronic pain and inflammation. ATB-352, the second drug in Antibe’s
pipeline, targets the urgent global need for a non-addictive analgesic
for treating severe acute pain, while ATB-340 is a GI-safe derivative of
aspirin. Citagenix Inc., an Antibe subsidiary, is a market leader and
worldwide distributor of regenerative medicine products for the dental
marketplace. www.antibethera.com
Forward Looking Information
This news release includes
certain forward-looking statements, which may include, but are not
limited to, 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 ability 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.