Antibe Therapeutics Inc.:
- Phase II secondary data confirmed
remarkable potency of ATB-346 -
- 3rd party commercial studies project peak
annual sales of $5.3 billion across seven key countries -
- Large market partnering efforts to
accelerate in parallel with Phase III program -
- Non-opioid painkiller advancing towards
the clinic; pipeline expansion initiatives underway -
To our shareholders,
As we transition into a Phase III company, we want to take the
opportunity to highlight recent progress and to outline our
strategy as we pursue monetization of our promising drug candidates
and hydrogen sulfide platform.
RECENT DEVELOPMENTS
Analysis of Phase II Dose-Ranging, Efficacy Data Now
Complete
Having completed the analysis of primary and secondary data from
ATB-346’s recent placebo-controlled efficacy trial, we can
confidently report strong results across all key measures.
The WOMAC pain scores constituting the study’s primary endpoint
showed 44% improvement from baseline at day 14 for the 200 and 250
mg once-daily doses, and 39% for the 150 mg once-daily dose. NSAIDs
typically reach their maximum effectiveness after 6-8 weeks of
administration and remain at that level while treatment continues.
ATB-346 produced significant decreases in pain within 2 weeks of
treatment. All three doses of ATB-346 reflect well in light of
results from a recent peer-reviewed meta-analysis of historical
NSAID osteoarthritis pain trials from Harvard researchers1. (For
further information, please see our website and updated Corporate
Presentation).
Beyond the impressive pain relief, ATB-346 also delivered
significant improvements in the two secondary endpoints that
address therapeutic benefit for patients: the WOMAC scores for
stiffness and for difficulty in performing daily activities. These
results are important, ‘real-world’ measures for patients with
osteoarthritis (“OA”) and provide additional support for the drug’s
best-in-class positioning.
Supplementing the WOMAC results are the secondary data of
cyclo-oxygenase (“COX”) enzyme inhibition. NSAIDs reduce pain and
inflammation by inhibiting the activity of COX enzymes. ATB-346
exhibited profound inhibition of COX (all doses yielding >90%
inhibition) with a very high degree of statistical significance,
and with negligible difference observed across the three doses.
This is exceptionally strong data that is consistent with
self-assessment of pain by the patients.
Adverse events across the three doses of ATB-346 were similar to
placebo, with very few serious adverse events or events leading to
withdrawal of treatment. Adjudicating for patient-specific factors
reflected a liver safety profile for ATB-346 that was comparable to
commonly prescribed NSAIDs, and substantially improved over that of
acetaminophen.
Trial participants treated with ATB-346 experienced neither an
increase nor decrease in blood pressure in contrast with other
NSAIDs, which often increase blood pressure. Blood pressure
increases are viewed by medical practitioners globally as being an
important proxy for the cardiovascular risk of NSAIDs. The absence
of an increase in blood pressure has been a consistent finding in
all of ATB-346’s clinical trials to-date and suggests a favourable
cardiovascular safety profile for the drug.
Human Proof-of-Concept Now Firmly Established for
ATB-346
The strong Phase II efficacy results from this trial are a
worthy complement to Antibe’s Phase II gastrointestinal (“GI”)
safety trial, published last year in the British Journal of
Pharmacology2. That study demonstrated unequivocal GI safety
superiority of ATB-346 over naproxen, one of the most prescribed
NSAIDs in the US. This combined evidence for GI safety and efficacy
firmly validates ATB-346 as a potential best-in-class therapy,
indicating that we are on the verge of solving one of the most
pervasive medical problems of our time, namely the ulcers and
bleeding caused by NSAIDs.
Third Party Commercial Studies Validate Blockbuster Potential
of ATB-346
In addition to completing strong GI safety and efficacy studies
over the past two years, we have conducted an extensive series of
market and commercial studies in key pharmaceutical markets — a
total of four studies were completed, framing an impressive
commercial opportunity for ATB-346 and preparing us well for
late-stage partner engagement and monetization.
This effort began with a thorough health economics study led by
US-based Avalon Health, quantifying the major economic impact to
society arising from the damage caused by today’s NSAIDs. A
subsequent commercial positioning study executed by an ex-Amgen
strategy consulting team validated ATB-346’s target product profile
and best-in-class positioning.
The results of these two initial studies served as the
foundation for two comprehensive commercial studies for the large
markets (namely, the US, the five largest European countries, and
Japan), led by Shift Health and LEK, two well-respected strategy
consultancies. These studies involved extensive primary and
secondary research, including 62 interviews with country-specific
clinicians, payors and pharmacy benefit managers – whose
preferences and policies together determine the adoption of new
drugs. This was followed by an in-depth survey of 80 clinicians,
including primary care physicians, rheumatologists and orthopedic
surgeons that prescribe NSAIDs on a daily basis. Finally, the
studies developed detailed revenue models, utilizing the uptake and
pricing information obtained from the research and interview phases
of the project.
For the OA market alone, Antibe’s initial focus, peak annual
sales of $5.3 billion are projected for ATB-346 in these seven
countries, and cumulative revenues in excess of $28 billion by the
early 2030s. These projections conservatively assume peak adoption
of 21% and only represent 65% of the global market. Pricing and
reimbursement, which drive a drug’s adoption and ability to gain
market share, were favourable, with limited system resistance and
few reimbursement hurdles expected. The forecasts assumed a price
of US$6 per day in the US, in line with today’s branded
prescription NSAIDs, with corresponding pricing in the other
markets. The revenue projections combined with a high anticipated
gross margin imply an impressive net present value of ATB-346,
which is how potential partners determine a drug’s expected value.
(For further information, please see our website and updated
Corporate Presentation).
STRATEGY AND NEXT STEPS
With human proof-of-concept development and key commercial
studies complete, we now have a clear line-of-sight to the
significant revenue and margin potential of ATB-346. Our strategic
objective is now to monetize this asset through partnering
activity, while at the same time expeditiously moving forward with
Phase III development. This parallel strategy is important, as
partnering outreach and execution is an extensive, involved
process, and the continued advancement of the drug’s development
program is expected to increase market value and negotiating
leverage.
Executive Team Evolving to Support Late Stage Development and
Partnering
We continue to deepen the capabilities of our senior team,
including the recent hiring of Dr. Rami Batal to guide our
commercial strategy, and Dr. Joseph Stauffer as the Company’s Chief
Medical Officer. Dr. Stauffer’s experience as an FDA reviewer,
along with more than fifteen years of guiding regulatory strategy
for other pain therapeutics, has already been invaluable as we
pursue our regulatory, development and commercial strategies in the
US and other markets. We are also hiring a US-based senior business
development officer to execute the large market partnering, who
will be armed with fully validated human proof-of concept data and
a robust package of third-party commercial assessments.
Strategic out-licensing and monetization discussions are
underway and have benefited from the strength of the recent
efficacy data, while partnering discussions in the major markets
are expected to accelerate following specific regulatory engagement
with both the Food and Drug Administration (“FDA”) in the US and
the European Medicines Agency (“EMA”) in Europe. We are encouraged
by the preliminary feedback and hope to report on the progress on
this front over the coming months.
Phase III Preparation and Regulatory Strategy Well
Underway
With the successful conclusion of ATB-346’s Phase II studies and
acceleration of partnering activities, preparation for Phase III
trials is well underway. The Phase III program will replicate the
Phase IIB GI safety and dose-ranging, efficacy studies with larger
sample sizes and longer treatment durations. The first registration
trial of the Phase III program will use a multi-arm design to
establish the lowest effective dose and is anticipated to begin
next spring, with the follow-on trials starting in a staggered
fashion every several months thereafter. The strategy is global in
nature, with the first trials focusing on the US and the last trial
expected to address the unique regulatory requirements for Europe
and the key Asian markets. The go-to-market indication will be OA,
although we intend to rapidly expand this to encompass ankylosing
spondylitis, rheumatoid arthritis and other chronic pain
conditions. It is worth noting that successful completion of Phase
III development would enable the Company to file a New Drug
Application (“NDA”) with the FDA and other regulatory agencies for
marketing approval. This approval would deliver the first truly
novel NSAID in over 20 years, and a major breakthrough in the safe
and non-addictive treatment of pain and inflammation.
As part of Phase III preparation, we completed our Pre-IND
(“Investigational New Drug”) meeting for ATB-346 with members of
the US FDA Division of Anesthesiology, Addiction Medicine, and Pain
Medicine. Based on the valuable guidance received, we are moving
expeditiously to complete and submit an IND application to the FDA
for ATB-346. Prior to the start of the first Phase III trial, we
anticipate an End-of-Phase II Meeting with the FDA and the
equivalent meeting with the EMA, which will strengthen Antibe’s
position with potential large market partners.
We are pleased to have recently received approval for ATB-346’s
International Nonproprietary Name: otenaproxesul. (The
non-proprietary name is equivalent to, for example, the “ibuprofen”
of Advil®). We will be using otenaproxesul going forward, and our
Corporate Presentation and website have been amended as such. In
addition, we have now engaged a healthcare branding agency to help
us select a proprietary (brand) name (the equivalent to
“Advil®”).
ATB-352 Advancing Towards Clinical Development Next
Year
Expanding beyond our lead drug, we have commenced IND-enabling
preclinical studies for our second pipeline drug, ATB-352. This
drug is being developed as a GI-safe and non-addictive alternative
to opioids for the treatment of post-surgical pain, a US$11 billion
market3. Many physicians find themselves in a quandary regarding
opioids, which have been the drug-of-choice for post-surgical pain.
The natural alternative would be the stronger NSAIDs, already shown
to equal the pain relief of opioids in such settings. However, such
NSAIDs are also the most harmful to the digestive tract. ATB-352, a
hydrogen sulfide-releasing version of ketoprofen (a particularly
strong NSAID), is being developed as a solution to this
longstanding problem. In animal experiments, ATB-352 has delivered
greater pain effectiveness than ketoprofen yet demonstrated robust
GI safety. We anticipate that preclinical studies of ATB-352 will
conclude in calendar Q3 2021, following which we will seek
regulatory approval to initiate human trials. We plan to pursue a
Fast Track designation with the FDA to expedite the development and
regulatory approval process.
Our third pipeline drug, ATB-340, a hydrogen-sulfide releasing
version of low-dose aspirin, has been shown to cause negligible GI
damage in preclinical studies. Low-dose aspirin is generally
regarded as a wonder drug for cardiovascular and cancer protection
for people over 50, but its prevalence of GI-damage precludes its
broad prescription by clinicians. We are presently evaluating the
clinical development strategy for ATB-340 and anticipate commencing
IND-enabling preclinical studies in calendar 2021.
Pipeline Expansion Initiatives Launched
The strength of the recent clinical data has also encouraged us
to commit to unlocking additional value from our hydrogen sulfide
platform. To this end, Antibe recently signed a contract with a
leading academic institution in the US known for the quality of its
hydrogen sulfide science. The objective of this mandate is to
identify promising new hydrogen sulfide-releasing compounds for the
treatment of chronic pain, acute pain and other indications,
including inflammatory bowel disease. Antibe will retain ownership
rights to any new intellectual property arising from this work.
In addition, we are exploring collaborations for additional
indications for otenaproxesul, including familial adenomatous
polyposis (FAP), a pre-cancerous and often-fatal orphan
disease.
Capital Markets Strategy Taking Institutional Focus
The success of otenaproxesul over the past few years has
increased our valuation and de-risked our story considerably – this
could not have been done without the long-term support of our
existing shareholders. The last several months culminated in
significant achievements, including a $29 million bought deal
financing, that position us well to crystalize the value of our
efforts. While we believe the issue price did not reflect the
opportunities before us, the financing was essential for executing
our plans in the coming 15 months at full speed with a fully funded
balance sheet. We will now be pursuing a capital markets strategy
to support our next stage of growth, while enabling our share price
to reach an inherent value that is more comparable to our Phase III
peers.
The completion of human proof-of-concept development for
otenaproxesul with such strong results has put us on the radar
screens of institutional investors that will be instrumental in
supporting this growth. Preparations are largely complete to list
on a senior exchange at the optimal time, such as NASDAQ. In
addition, we will shortly engage a premier life science-focused
investor relations firm in the US to implement and lead a strategic
outreach program towards institutional investors, sell-side
analysts and bankers.
We are in the process of evaluating a potential sale of
Citagenix, our commercial asset that is no longer a strategic fit.
This will simplify our story into a “pure play” late-stage biotech
company with a clear focus and growth trajectory. And as we attract
more institutions and mature as an organization, we will
correspondingly require more active and deepened governance to
guide our decision-making. We have retained a specialized
recruitment firm to help us find a new, US-based Board member, whom
we expect to have in place by year end.
We are excited by the opportunities ahead, as we strive to
unlock shareholder value and execute our strategy over the course
of the coming year.
Sincerely,
Dan Legault
Chief Executive Officer
1 Comparative Pain Reduction of Oral Non-steroidal
Anti-inflammatory Drugs and Opioids for Knee Osteoarthritis:
Systematic Analytic Review. Osteoarthritis and Cartilage. S.R.
Smith et al., 2016.
2 A proof-of-concept, Phase 2 clinical trial of the
gastrointestinal safety of a hydrogen sulfide-releasing
anti-inflammatory drug. British Journal of Pharmacology. Wallace et
al., 2019.
3 Transparency Market Research, 2018.
About Antibe Therapeutics Inc.
Antibe develops safer, non-addictive medicines for pain and
inflammation. Antibe’s technology involves the linking of a
hydrogen sulfide-releasing molecule to an existing drug to produce
an 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 post-surgical 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 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.
Neither TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200804005417/en/
Antibe Therapeutics Inc. Christina Cameron VP Investor Relations
+1 416-922-3460 christina@antibethera.com
Antibe Therapeutics (TSXV:ATE)
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Antibe Therapeutics (TSXV:ATE)
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