- Phase III preparations proceeding well;
AME study underway
- New IP in development to expand
indications and bolster existing pipeline
- Potential listing on senior U.S. exchange
synchronized with first Phase III trial
Antibe Therapeutics Inc.:
To our shareholders,
Our achievements in the last twelve months have set the stage
for a promising year ahead. With a cash position that provides more
than two years of runway and fully funds the initial Phase III
trial, we are adding value through comprehensive clinical
development, ongoing partnering engagement and multi-pronged
intellectual property (“IP”) advancement.
Otenaproxesul’s Clinical Development on Track
With the U.S. FDA’s recent clearance of otenaproxesul’s
Investigational New Drug (“IND”) application and the requisite
animal toxicology studies now complete, the receding COVID-19
pandemic is enabling us to solidify plans for our first Phase III
trial. Involving approximately 750 patients, this efficacy trial is
planned for approximately 50 sites in the U.S. and Canada, with
enrollment set to commence in Q1 2022. The associated CMC
(chemistry, manufacturing and controls) activities are on schedule,
with drug tablet and placebo production well in hand by our global
manufacturing partner.
Antibe is taking a comprehensive approach to maximizing the
likelihood of a successful Phase III program outcome. We are
currently evaluating proposals from leading global contract
research organizations (“CROs”) with extensive osteoarthritis
clinical trial experience; we expect to finalize our choice within
weeks. The program also combines several state-of-the-art aspects,
including the hiring of leading providers of bioanalytic, quality
control and data management services. The latter will enable us to
track and manage screening and enrollment in real-time, ensuring
that the subject population matches trial criteria. To mitigate the
risks that arise in the conduct of every placebo-controlled pain
trial, we have contracted with one of the world’s foremost
providers of clinic staff and patient education to ensure accurate
and consistent reporting of pain scores and other measures. This
firm will also provide us with real-time data during the trials,
enabling us to make timely interventions if data quality issues
arise – all without unblinding the trials. We have also retained a
former chair of the U.S. FDA’s Advisory Committee on Anesthesia,
Critical Care and Addiction Products for ongoing advice to ensure
that our process meets FDA expectations for approving a novel
chronic pain therapeutic.
We are also in the process of selecting three physicians to
constitute the Independent Data Monitoring Committee (“IDMC”), a
key de-risking aspect of the initial trial’s adaptive design.
Favorably viewed by the FDA, adaptive design increases trial
control and flexibility while maintaining statistical integrity.
Once 50% of the patients in the trial have completed treatment, the
IDMC will review the data, allowing for sample size increases to
preserve statistical powering if needed. Achieving statistically
significant superiority to placebo in this trial would be a major
clinical milestone for our company. The balance of the Phase III
program involves a second efficacy trial and a gastrointestinal
(“GI”) safety trial. An additional efficacy trial will be required
to provide data specifically for European and Asian regulators.
The Phase III program will be overseen by Dr. Joseph Stauffer,
our Chief Medical Officer. Dr. Stauffer is a former analgesic and
anti-inflammatory drug reviewer at the FDA as well as a pioneer in
the design and conduct of adaptive analgesic trials, with
experience as chair and member of several IDMCs. To support the
expansion of our development activities, we continue to strengthen
our team, including the recent hiring of Dr. Ana Stegic as our
Director of Clinical Operations. Dr. Stegic is a medical doctor
with more than fifteen years of experience in managing global
clinical trials for large U.S.-based CROs.
In the lead-up to Phase III program initiation, we are taking
the opportunity to conduct two smaller clinical studies to support
our commercial, regulatory and drug development priorities. To be
completed this quarter, we are conducting an IND-opening
single-dose detailed pharmacokinetics/ pharmacodynamics study in 24
healthy volunteers at a U.S. site. Subjects have received the drug
and post-administration monitoring is complete, with data analysis
now underway.
Earlier this month, we initiated an absorption, metabolism and
excretion (“AME”) study involving a total of 90 healthy volunteers
being randomized to lower doses of otenaproxesul. The drug will be
administered to each dose cohort for four weeks, followed by two
weeks of post-drug monitoring. In addition to providing valuable
information for potential partners, this study will further de-risk
dose selection for the Phase III program, while also supplying
pharmacokinetic data required for drug marketing approval.
Following the anticipated completion of this study in the upcoming
quarter, we will request a meeting with the FDA; that meeting will
be the last key milestone before Phase III initiation.
Recent Validation Driving Partnering Activity
As we focus our partnering efforts on the large markets of the
U.S., U.K., the four largest E.U. countries and Japan, we are
benefiting from the validation inherent in our licensing deal
earlier this year with Nuance Pharma in China. Supported by the
unification of our IP ownership and the hiring of a premier pharma
transaction firm to manage a formal outreach process, we are now
interacting with pharmaceutical companies around the globe, with
several conversations having reached the confidential stage.
Recognizing that we are on the cusp of solving a problem that has
challenged medical practice for 50 years, our strong corporate
position provides us with the opportunity to select partners that
can fully exploit otenaproxesul’s potential.
IP Development Creating New Value
In parallel with our Phase III preparations, we are working to
realize the potential of our hydrogen sulfide platform through a
cost-effective, early-stage research and development program. As
recently announced, we have entered into a strategic collaboration
with Dalriada Drug Discovery to aid us in identifying new drug
candidates and to fortify the IP position of our current pipeline.
Dalriada is presently screening molecules to select our go-forward
candidate for inflammatory bowel disease (“IBD”), a process
expected to be completed within months. With inflammation
increasingly understood to underlie a wide range of health
conditions, we look forward to broadening our pipeline to address
this pervasive medical issue. We are also pursuing the development
of fresh IP to lengthen the duration of patent and market
protection available to our peri-operative pain and aspirin-based
drug candidates.
Potential Listing on Senior U.S. Exchange Synchronized with
Phase III Initiation
Our preparations for a potential listing on a senior U.S.
exchange are largely complete. To capture the momentum of our
upcoming Phase III program initiation, we are synchronizing a
potential U.S. uplisting with our first Phase III trial. We also
recognize that the completion of a strategic transaction for
Citagenix would simplify Antibe’s story for new investors, and we
are actively engaged in pursuing such an arrangement.
With a state-of-the-art Phase III design, enhanced bench
strength and the support of a team of world-class service
providers, we are poised to embark on the final phase of
development of a best-in-class solution for millions of
osteoarthritis patients and their doctors. Enabled by a strong
balance sheet and heightened industry visibility, we also are
well-positioned to partner with companies that can capture
otenaproxesul’s potential. Our efforts to target inflammation more
broadly are underway, addressing unmet medical needs across a
spectrum of indications.
We look forward to updating you on our progress.
Sincerely,
Dan Legault Chief Executive Officer
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-sparing 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, and the potential of
a US listing. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210727005359/en/
Antibe Therapeutics Inc. Christina Cameron VP Investor Relations
+1 416-577-1443 christina@antibethera.com
Antibe Therapeutics (TSX:ATE)
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