Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical
company focused on developing and commercializing differentiated
products that address patients’ unmet needs and solve therapeutic
problems, announced today that it has submitted an Investigational
New Drug (IND) application to the U.S. Food and Drug Administration
(FDA) for pharmacokinetic (PK) clinical trials of its drug
candidate AQST-108, a “first of its kind” oral sublingual film
formulation delivering systemic epinephrine that is in development
for the treatment of anaphylaxis using Aquestive’s proprietary
PharmFilm® technologies. The Company intends to initiate its
planned PK trials before the year end 2020.
Aquestive plans to initiate its PK clinical
trials of AQST-108 in a crossover study to compare the
pharmacokinetics and pharmacodynamics of epinephrine administered
as sublingual film to that of epinephrine administered as an
injection. As proposed by Aquestive and confirmed by the FDA at the
pre-IND meeting held in February 2020, the clinical development for
AQST-108 will be reviewed under the 505(b)(2) regulatory approval
pathway. The FDA acknowledged that there appears to be an unmet
medical need among patients who resist the standard of care use of
subcutaneous and intramuscular injection in the treatment of
anaphylaxis. The Company believes that AQST-108 may potentially
address some of those unmet needs.
“As we have committed, we have completed the
filing of the IND for AQST-108, which is a significant milestone
for this development program. We are on track to commence our PK
study before year end,” said Keith J. Kendall, Chief Executive
Officer of Aquestive. “Anaphylaxis is a serious condition that
impacts a large patient population for which there is a significant
unmet need. The only options currently available to patients
require an injection and, if approved by the FDA, AQST-108 can
potentially bring meaningful innovation and positive change for
patients. We are focused on providing the first highly portable,
easy-to-administer and anxiety-free sublingual film medication to
treat this serious condition.”
About AQST-108AQST-108 is a
“first of its kind” oral sublingual film formulation delivering
systemic epinephrine that is in development for the treatment of
anaphylaxis using Aquestive’s proprietary PharmFilm®
technologies.
The data from the previously completed Phase 1
dose escalation study demonstrated that AQST-108 achieved similar
ranges of mean values of maximum concentration (Cmax) and time to
reach maximum concentration (Tmax) to that reported for injectables
EpiPen® and Auvi-Q®, provided a greater total exposure (AUC0-t;
area under the curve) than that reported for EpiPen and Auvi-Q, had
less interpatient variability when compared to degree of variation
(CV%) data reported for EpiPen and Auvi-Q, and was well tolerated,
with no study participants discontinuing participation due to an
adverse event.
Anaphylaxis is a potentially life-threatening
systemic allergic reaction, with an estimated incidence of 50 to
112 episodes per 100,000 people per year. The frequency of hospital
admissions for anaphylaxis has increased 500-700% in the last 10-15
years.1 The most common causes of reactions that can include
anaphylaxis are medications, foods (such as peanuts), and venom
from insect stings. Epinephrine injection is the current standard
of treatment intended to reverse the potentially severe
manifestation of anaphylaxis, which may include red rash, throat
swelling, respiratory problems, gastrointestinal distress and loss
of consciousness.
About Aquestive
TherapeuticsAquestive Therapeutics is a pharmaceutical
company that applies innovative technology to solve therapeutic
problems and improve medicines for patients. Aquestive is advancing
a late-stage proprietary product pipeline to treat CNS conditions
and provide alternatives to invasively administered standard of
care therapies. The Company also collaborates with other
pharmaceutical companies to bring new molecules to market using
proprietary, best-in-class technologies, like PharmFilm®, and has
proven capabilities for drug development and commercialization.
Forward-Looking StatementThis
press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Words such as “believe,” “anticipate,” “plan,” “expect,”
“estimate,” “intend,” “may,” “will,” or the negative of those
terms, and similar expressions, are intended to identify
forward-looking statements. These forward-looking statements
include, but are not limited to, statements regarding therapeutic
benefits and plans and objectives for regulatory approvals of
AQST-108, Libervant™ and our other product candidates; ability
to obtain FDA approval and advance AQST-108, Libervant and our
other product candidates to the market, statements about our growth
and future financial and operating results and financial position,
regulatory approval and pathways, clinical trial timing and plans,
our and our competitors’ orphan drug approval and resulting drug
exclusivity for our products or products of our competitors,
short-term and long-term liquidity and cash requirements, cash
funding and cash burn, business strategies, market opportunities,
and other statements that are not historical facts. These
forward-looking statements also are subject to the uncertain impact
of the COVID-19 global pandemic on our business including with
respect to our clinical trials including site initiation, patient
enrollment and timing and adequacy of clinical trials; on
regulatory submissions and regulatory reviews and approvals of our
product candidates; pharmaceutical ingredient and other raw
materials supply chain, manufacture, and distribution; sale of and
demand of our products; our liquidity and availability of capital
resources; customer demand for our products and services;
customers’ ability to pay for goods and services; and ongoing
availability of an appropriate labor force and skilled
professionals. Given these uncertainties, the Company is unable to
provide assurance that operations can be maintained as planned
prior to the COVID-19 pandemic.
These forward-looking statements are based on
our current expectations and beliefs and are subject to a number of
risks and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements.
Such risks and uncertainties include, but are not limited to, risks
associated with the Company's development work, including any
delays or changes to the timing, cost and success of our product
development activities and clinical trials and plans; risk of
delays in FDA approval of Libervant and our other drug candidates
or failure to receive approval; risk of our ability to demonstrate
to the FDA “clinical superiority” within the meaning of the FDA
regulations of our drug candidate Libervant relative to
FDA-approved diazepam rectal gel and nasal spray products including
by establishing a major contribution to patient care within the
meaning of FDA regulations relative to the approval of products and
there can be no assurance that we will be successful; risk that a
competitor obtains FDA orphan drug exclusivity for a product with
the same active moiety as any of our other drug products for which
we are seeking FDA approval and that such earlier approved
competitor orphan drug blocks such other product candidates in the
U.S. for seven years for the same indication; risk inherent in
commercializing a new product (including technology risks,
financial risks, market risks and implementation risks and
regulatory limitations); risk of development of our sales and
marketing capabilities; risk of legal costs associated with and the
outcome of our patent litigation challenging third party at risk
generic sale of our proprietary products; risk of sufficient
capital and cash resources, including access to available debt and
equity financing and revenues from operations, to satisfy all of
our short-term and longer term cash requirements and other cash
needs, at the times and in the amounts needed; risk of failure to
satisfy all financial and other debt covenants and of any default;
risk related to government claims against Indivior for which we
license, manufacture and sell Suboxone® and which accounts for the
substantial part of our current operating revenues; risk associated
with Indivior’s cessation of production of its authorized generic
buprenorphine naloxone film product, including the impact from loss
of orders for the authorized generic product and risk of eroding
market share for Suboxone and risk of sunsetting product; risks
related to the outsourcing of certain sales, marketing and other
operational and staff functions to third parties; risk of the rate
and degree of market acceptance of our product and product
candidates; the success of any competing products, including
generics; risk of the size and growth of our product markets; risks
of compliance with all FDA and other governmental and customer
requirements for our manufacturing facilities; risks associated
with intellectual property rights and infringement claims relating
to the Company's products; risk of unexpected patent developments;
the impact of existing and future legislation and regulatory
provisions on product exclusivity; legislation or regulatory
actions affecting pharmaceutical product pricing, reimbursement or
access; claims and risks that may arise regarding the safety or
efficacy of the Company's products and product candidates; risk of
loss of significant customers; risks related to legal proceedings,
including patent infringement, investigative and antitrust
litigation matters; changes in government laws and regulations;
risk of product recalls and withdrawals; uncertainties related to
general economic, political, business, industry, regulatory and
market conditions and other unusual items; and other uncertainties
affecting the Company described in the “Risk Factors” section and
in other sections included in our Annual Report on Form 10‑K, in
our Quarterly Reports on Form 10-Q, and in our Current Reports on
Form 8-K filed with the Securities Exchange Commission (SEC). Given
those uncertainties, you should not place undue reliance on these
forward-looking statements, which speak only as of the date made.
All subsequent forward-looking statements attributable to us or any
person acting on our behalf are expressly qualified in their
entirety by this cautionary statement. The Company assumes no
obligation to update forward-looking statements or outlook or
guidance after the date of this press release whether as a result
of new information, future events or otherwise, except as may be
required by applicable law.
PharmFilm® and the Aquestive logo are registered
trademarks of Aquestive Therapeutics, Inc. All other registered
trademarks referenced herein are the property of their respective
owners.
Investor Inquiries: Stephanie Carrington
stephanie.carrington@icrinc.com 646-277-1282
1 Epidemiology of anaphylaxis. Tejedor Alonso MA, Moro Moro M,
Mugica Garcia MC, Clin Exp Allergy. 45(6):1027-39, Jun 2015
Aquestive Therapeutics (NASDAQ:AQST)
Historical Stock Chart
From Mar 2024 to Apr 2024
Aquestive Therapeutics (NASDAQ:AQST)
Historical Stock Chart
From Apr 2023 to Apr 2024