Antibe Therapeutics Receives FDA Clearance of IND Application for Otenaproxesul for Osteoarthritis Pain
Antibe Therapeutics Inc. has received FDA clearance for its Investigational New Drug application for otenaproxesul, aimed at treating osteoarthritis pain. This approval allows the company to initiate human clinical trials in the U.S., with plans to begin its Phase III program later this year. The company's comprehensive submission included over 55,000 pages of data from previous Phase II trials. Antibe is focused on developing safer therapies for inflammation, with other pipeline assets targeting opioid alternatives and gastrointestinal protection.
- FDA clearance received for otenaproxesul, enabling human clinical trials.
- Phase III program anticipated to commence later this year.
- Comprehensive IND application included over 55,000 pages of Phase II data.
- None.
Antibe Therapeutics Inc. (TSX: ATE, OTCQX: ATBPF), a clinical stage company leveraging its hydrogen sulfide platform to develop next-generation safer therapies for inflammation arising from a wide range of medical conditions, today announced that the U.S. Food and Drug Administration (“FDA”) has cleared the Company’s Investigational New Drug (“IND”) application for otenaproxesul, in development for the treatment of osteoarthritis pain. This enables Antibe to undertake human clinical trials in the U.S.; as previously announced, Antibe anticipates initiating its Phase III program later this year.
“We are pleased to have been authorized to proceed with our clinical program for otenaproxesul,” commented Dr. Joseph Stauffer, Antibe’s Chief Medical Officer. “Because we completed Phase II trials prior to the IND application, we were able to provide a comprehensive package of preclinical and clinical data in a submission comprising more than 55,000 pages. We look forward to working with the FDA as we pursue development of a gastrointestinal-protective, non-addictive analgesic for the many millions of patients seeking better medicines for osteoarthritis.”
About Antibe Therapeutics Inc.
Antibe is leveraging its proprietary hydrogen sulfide platform to develop next-generation safer therapies to address inflammation arising from a wide range of medical conditions. The Company’s current pipeline includes three assets that seek to overcome the gastrointestinal (“GI”) ulcers and bleeding associated with nonsteroidal anti-inflammatory drugs (“NSAIDs”). Antibe’s lead drug, otenaproxesul, is entering Phase III for the treatment of osteoarthritis pain. Additional assets under development include a safer alternative to opioids for peri-operative pain, and a GI-protective alternative to low-dose aspirin. The Company’s next target is inflammatory bowel disease (“IBD”), a condition long in need of safer, more effective therapies. Learn more at antibethera.com.
Forward Looking Information
This news release includes certain forward-looking statements, which may include, but are not limited to, the proposed 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 wording. 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 inability to secure additional financing and licensing arrangements on reasonable terms, or at all, 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 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.
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