Antibe Therapeutics Inc. ("Antibe" or the “Company”) (TSXV: ATE,
OTCQB: ATBPF), a leader in developing safer, non-addictive
therapeutics for pain and inflammation, is pleased to provide a
corporate update in conjunction with the filing of its financial
and operating results for the fiscal quarter ended September 30,
2019.
Phase 2B Dose-Ranging, Efficacy Study Nearing
Completion
The Company’s on-going Phase 2B dose-ranging, efficacy study is
evaluating the effectiveness of its lead drug, ATB-346, in reducing
osteoarthritis pain compared to placebo in 360 patients. Total
enrollment has surpassed 70% and patient recruitment has
accelerated due to several initiatives, including the activation of
an additional five clinical sites. This brings the total number of
clinical sites to 40, the largest number of sites for any clinical
trial ever conducted in Canada.
Dan Legault, Antibe’s CEO, remarked, “We’re pleased with the
conduct of the study, although enrollment has been slower than
originally anticipated. We’ve taken extra measures to expedite the
completion of enrollment, but with the inevitable slowdown during
the holiday season, we are pushing our guidance for top-line data
to calendar Q1 2020.”
The Company will issue a press release upon enrollment of the
last patient.
Balance Sheet Remains Strong; Recent Benefit from Warrant
Activity
Antibe reported a cash balance at September 30, 2019, of $8
million, which reflects the successful prospectus offering that was
concluded in August. Subsequently, the Company has raised $1.3
million from the exercising of warrants. The Company’s unaudited
fiscal Q2 2020 condensed interim consolidated financial statements
and MD&A will be available on SEDAR today.
Continued Progress with FDA Regulatory Requirements
The Company recently requested a Pre-Investigational New Drug
(“IND”) meeting to support its IND filing with the FDA and, in
parallel, is preparing for an end-of-Phase-2 FDA meeting. A
successful IND filing will allow for Phase 3 testing of ATB-346 in
the United States. In combination with a successful end-of-Phase-2
FDA meeting, Antibe will have achieved a valuable regulatory
milestone for potential partners seeking a Phase 3-ready asset. In
addition, the Company is pursuing the equivalent regulatory pathway
with the EMA to prepare ATB-346 for approval in Europe.
Preparing for Global Pharma Partnerships
The Company has advanced several independent market research
initiatives aimed at global partners, who will be focusing on
commercialization strategy as ATB-346 nears approval. This includes
a recently completed health economics study on the overall cost of
NSAID-related adverse events in the United States. The study
estimates that direct costs associated with NSAIDs, including the
treatment of adverse events, total approximately $74 billion
annually in the United States. It also estimates that the
introduction of ATB-346 could deliver significant savings to the US
healthcare system.
In addition, Antibe recently completed a commercial positioning
study for ATB-346, and has now engaged a leading life
science-focused consulting firm to conduct a comprehensive market
opportunity assessment and payor study for both the United States
and Europe. Collectively, these initiatives will complement the
scientific and clinical data that Antibe shares with potential
partners.
Global Supply Secured for ATB-346
Antibe is pleased to announce that it recently engaged a leading
global contract manufacturing organization (“CMO”) for ATB-346.
This contract supports the interests of Antibe and its potential
global partners by securing a reliable supply of ATB-346 to meet
regulatory approval timelines.
New Corporate Website Reflects Maturing Stage of
Company
The Company has launched its new corporate website reflecting
its refreshed brand and identity. The new website contains in-depth
information on Antibe’s science, drug pipeline and market
opportunity, making it a valuable resource for investors and future
partners.
Issuance of Restricted Share Units
It is the Company’s standard practice to grant equity
compensation awards on an annual basis. A total of 7,630,000
restricted share units (“RSUs”) were granted to directors,
officers, employees and consultants pursuant to the Company’s RSU
plan. The vesting of 50% of the RSUs granted to key executives will
be subject to the achievement of specific performance goals that
reflect the successful execution of the Company’s business plan and
strategy. In addition, all RSUs are subject to time-based vesting;
one third (1/3) of the RSUs granted will vest on each of the first,
second and third anniversaries of today’s date.
About ATB-346
ATB-346 is a hydrogen sulfide-releasing derivative of naproxen.
Nonsteroidal anti-inflammatory drugs (“NSAIDs”) are the most
commonly used therapy for osteoarthritis, but their use is
associated with a high incidence of gastrointestinal ulceration and
bleeding. NSAIDs are also widely used in conditions such as
rheumatoid arthritis, ankylosing spondylitis, gout, and general
pain reduction, with a similarly high rate of gastrointestinal
ulceration and bleeding. It is well-accepted that patients with
these conditions would benefit greatly from an effective,
non-addictive, GI-sparing anti-inflammatory/analgesic agent such as
ATB-346.
About Antibe Therapeutics Inc.
Antibe develops safer, non-addictive 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. Citagenix Inc., an Antibe subsidiary, is a market
leader and worldwide distributor of regenerative medicine products
for the dental marketplace. www.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 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191128005222/en/
Antibe Therapeutics Inc. Dan Legault Chief Executive Officer
(416) 473 4095 dan.legault@antibethera.com
Antibe Therapeutics (TSXV:ATE)
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Antibe Therapeutics (TSXV:ATE)
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