Antibe Therapeutics Inc. (TSXV: ATE, OTCQB: ATBPF):
To our stakeholders,
The recent success of our lead drug, ATB-346, in its Phase 2B
gastrointestinal (“GI”) safety clinical study was a significant
milestone for Antibe and represented a major inflection point in our
value. Furthermore, we are now one clinical study away from the
strategic monetization of our drug platform for the major markets. With
such an important and exciting time ahead of us, we thought this would
be an ideal opportunity to communicate our strategy for the next year
and beyond.
Nearly ten years ago, Antibe was formed to develop safer medicines for
pain and inflammation by leveraging our novel hydrogen sulfide (“H2S”)
technology. Over this period, our strategy to maximize value for
shareholders has remained consistent: advance our drug candidates to
Phase 2 proof-of-concept data and secure high-value partnerships for the
large pharmaceutical markets. Fast forward to 2018: we now have
unequivocal validation of our H2S platform, and are
well-positioned to conclude a series of transformational partnerships
over the next 12-18 months.
This progress could not have been done without the support of our
shareholders, who are now being rewarded for their patience over the
years. In the months ahead, our team will be working diligently to
ensure that our clinical and business development activities are well
aligned with our strategy to maximize shareholder return.
Recent Phase 2B Study Confirms Best-in-Class Status for Drug
Platform
In Antibe’s latest Phase 2B study, ATB-346 showed unequivocal
superiority to naproxen in GI safety (2.5% versus 42.1% ulceration rate)
in 244 healthy volunteers. This human proof-of-concept data replicated
the results of our pre-clinical studies, and provides clear validation
of the GI-protective properties of our H2S technology. The
full analysis of this study will be reported this quarter. We are now
pushing forward with the planned Phase 2 effectiveness study for
ATB-346, and are accelerating development of our other H2S
platform drugs. Each of Antibe’s drugs has blockbuster potential, and
would provide physicians and consumers with radically safer alternatives
to today’s NSAIDs and to the multi-dimensional dangers of
corticosteroids and opiates.
Upcoming Phase 2 Effectiveness Study Designed to Validate Efficacy
of ATB-346
With human GI safety for ATB-346 now firmly established, our next
clinical objective is to validate its effectiveness at reducing pain in
osteoarthritis (“OA”) patients. In August 2016, Antibe released top-line
data from a Phase 2A study that showed considerable pain relief for
ATB-346 at a once-daily dose of 250 mg – the pain relief observed was
nearly double that of naproxen and Celebrex based on published data.
Although these results were encouraging, the study was conducted in a
small number of patients and was not controlled. Our upcoming Phase 2
effectiveness study is designed to validate the pain reduction efficacy
of ATB-346 (versus control) and will be conducted in approximately 250
OA patients. In addition, we have biomarker data derived from Phase 1
and Phase 2 blood assays that suggest ATB-346 is effective at lower
doses; for this reason, the study will include two additional dosing
cohorts with the goal of determining the lowest effective dose.
Preparations are well underway for this study and we anticipate
commencing it by July with a data read-out in Q4 2018.
Additional Clinical Activities to Support Global Partnering Efforts
In addition to the Phase 2 effectiveness study, Antibe will also be
strategically allocating R&D spend towards activities that we feel will
be of the most value to global partners. These activities include: (i)
long-range animal toxicology studies (6 months and 9 months) for
ATB-346, a standard regulatory requirement for approval of any drug;
(ii) additional metabolic studies for ATB-346 to further strengthen our
understanding of its pharmacokinetic profile; and (iii) the completion
of IND-enabling studies for both ATB-352 and ATB-340, Antibe’s two other
H2S platform drugs. Although ATB-352 and ATB-340 are earlier
stage, both individually represent blockbuster drug opportunities and
have been considerably de-risked by the latest validation of our H2S
technology. We remain particularly excited about the potential of
ATB-352, a non-addictive, potent analgesic for acute pain that directly
addresses the global opioid epidemic, a crisis that the world is
struggling to contain.
Partnering Discussions Building Momentum
In the past, Antibe’s partnering efforts were focused on strategically
out-licensing the rights for smaller markets (i.e., outside of the
United States and Western Europe). We continue to have these discussions
and have been successful in concluding two regional deals to-date – this
activity remains valuable as it provides non-dilutive funding and
further validation of our drug platform. The recent human
proof-of-concept GI safety data have undoubtedly benefited these
on-going discussions, and more importantly, now allow us to engage
multinational pharmaceutical firms to secure strategic partnerships for
the large markets. As mentioned earlier, our clinical development
activities in the next 12 months are designed to maximize the value of
our drug platform and strengthen our position as we engage potential
partners.
Commercial Asset in Regenerative Medicine Well-Positioned For
Growth
Our subsidiary, Citagenix Inc. (“Citagenix”), is nearly done assembling
the building blocks for its growth strategy in the dental regenerative
medicine market. Citagenix’s sales team in the United States is working
hard at expanding its distribution network, and recently signed Benco
Dental, the 3rd largest dental distributor in the US by
market share. Antibe’s relationship with Citagenix has been a symbiotic
one: Antibe provided the resources to position Citagenix on a growth
trajectory while Citagenix provided valuable diversification. With
Citagenix now on a path to growth and Antibe’s drug development
activities de-risked considerably by the recent GI safety data, our team
will now begin exploring strategic alternatives for Citagenix in an
effort to unlock value for shareholders.
Strong Balance Sheet and Maturing Capital Markets Strategy
Antibe’s balance sheet is well-funded with approximately $5 million of
cash, and recently benefited from the entire conversion of its
debentures. The upcoming Phase 2 effectiveness trial for ATB-346 will be
funded entirely with cash-on-hand. In addition, given our stage of
development, we are now exploring a listing on the NASDAQ exchange to
grow our institutional investor base in the United States.
We look forward to the year ahead as we drive closer towards our goal of
bringing safer medicines to market for pain and inflammation.
Sincerely,
Dan Legault
Chief Executive Officer
About Antibe Therapeutics Inc.
Antibe develops safer 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. https://ift.tt/2BWXRQt;
Antibe’s subsidiary, Citagenix Inc. (“Citagenix”), is a leader in the
sales and marketing of tissue regenerative products servicing the
orthopedic and dental marketplaces. Since its inception in 1997,
Citagenix has become an important source of knowledge and experience for
bone regeneration in the Canadian medical device industry. Citagenix is
active in 15 countries, operating in Canada through its direct sales
teams, and internationally via a network of distributor partnerships. www.citagenix.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
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 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 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.
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