Antibe Completes First Clinical Study of Otenaproxesul’s New Formulation
November 01 2023 - 7:00AM
Business Wire
- All treatments well tolerated with no
adverse safety signals
- No elevations in liver enzymes
Antibe Therapeutics Inc. (TSX: ATE, OTCQX: ATBPF), a
clinical-stage biotechnology company leveraging its hydrogen
sulfide platform to develop next-generation therapies targeting
pain and inflammation, is pleased to announce the completion of the
pharmacokinetic/pharmacodynamic (“PK/PD”) study of otenaproxesul’s
faster-absorbing formulation for acute pain. The study was designed
to confirm the drug’s safety and inform treatment regimens for the
upcoming Phase II trial, on track to launch in calendar Q1
2024.
The PK/PD study involved 36 healthy volunteers randomized across
three treatment arms: a single high dose and two five-day regimens
of otenaproxesul. The five-day regimens were chosen to correspond
to regimens envisaged for the upcoming Phase II trial. Subjects
remained in-clinic for the duration of their treatment. All
subjects completed the study with no clinically significant,
drug-related adverse events and no elevation in liver enzymes
during treatment or in post-treatment follow up.
“Today’s excellent safety results reflect a significant,
multi-pronged effort by Antibe’s team, leading liver scientists and
our global manufacturing partner,” commented Dan Legault, Antibe’s
CEO. “We’re particularly encouraged by the liver data, which map
beautifully to values predicted by DILIsym modeling. By helping
de-risk the new formulation, these safety results overcome a key
hurdle in otenaproxesul’s acute pain development path. We look
forward to analyzing and reporting on the PK results next
week.”
About Antibe Therapeutics Inc.
Antibe is a clinical-stage biotechnology company leveraging its
proprietary hydrogen sulfide platform to develop next-generation
therapies to target inflammation arising from a wide range of
medical conditions. The Company’s current pipeline includes assets
that seek to overcome the gastrointestinal ulcers and bleeding
associated with nonsteroidal anti-inflammatory drugs (“NSAIDs”).
Antibe’s lead drug, otenaproxesul, is in clinical development as a
safer alternative to opioids and today’s NSAIDs for acute pain.
Antibe’s second pipeline drug, ATB-352, is being developed for a
specialized pain indication. 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
under applicable securities laws, which may include, but are not
limited to, the anticipated scope, timing, duration and completion
of certain of the Company’s pre-clinical and clinical trial
programs and studies including the PK results of the PK/PD study
and Phase II trial and the anticipated timing for seeking market
approval for certain of the Company’s drugs and therapies for
certain additional indications. 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 timely execute on its business strategy
and timely and successfully complete its clinical trials and
studies, the Company’s inability to obtain the necessary regulatory
approvals related to its activities, risks associated with drug
development generally and those risk factors set forth in the
Company’s public filings made in Canada and available on sedar.com.
The Company 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/20231101977785/en/
Contact Information Antibe Therapeutics Inc. Christina
Cameron VP Investor Relations +1 416-577-1443
christina@antibethera.com
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