Antibe Therapeutics Receives FDA Clearance of IND Application for Otenaproxesul for Osteoarthritis Pain
March 29 2021 - 7:00AM
Business Wire
- Enables expansion to U.S.-based clinical
trials, advances preparation for Phase III program
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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version on businesswire.com: https://www.businesswire.com/news/home/20210329005189/en/
Antibe Therapeutics Inc. Christina Cameron VP Investor Relations
+1 416-577-1443 christina@antibethera.com
Stern Investor Relations Courtney Turiano +1 212-362-1200
courtney.turiano@sternir.com
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