Avenue Therapeutics Announces High Potency and Full Efficacy in a Model of Generalized Seizures for its Novel GABA-A Receptor Potentiator, BAER-101, Supporting Phase 2 Clinical Study
01 Agosto 2023 - 2:30PM
Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the
“Company”), a specialty pharmaceutical company focused on the
development and commercialization of therapies for the treatment of
neurologic diseases, announced today that BAER-101, the Company’s
potentially best-in-class selective GABA-A α2,3 positive
allosteric modulator (“PAM”), significantly suppressed seizures in
a translational animal model of absence epilepsy.
“These preclinical results demonstrate the
potential of BAER-101 to improve the current treatment landscape of
epilepsy with a differentiated approach designed to improve the
safety profile compared to existing drugs, which are often not
well-tolerated due to side effects including sedation, cognitive
impairment, ataxia and addiction,” said Alexandra MacLean, M.D.,
Chief Executive Officer of Avenue. “As we advance toward
potentially initiating a Phase 2a study in 2024, we are encouraged
by these results, showing BAER-101’s best-in-class potential for
patients with increased tolerability, potency and efficacy.”
BAER-101 underwent preclinical in vivo
evaluation in SynapCell's Genetic Absence Epilepsy Rat from
Strasbourg (“GAERS”) model of absence epilepsy. The GAERS model
mimics behavioral, electrophysiological and pharmacological
features of human absence seizures. The GAERS model is a
proven, early, informative indicator of efficacy in anti-seizure
drug development, with high predictability of response in humans.
In the model, BAER-101 demonstrated full suppression of seizure
activity with a minimal effective dose of 0.3 mg/kg, PO.
The effect was fast in onset and stable throughout the duration of
testing.
BAER-101 has previously been shown to be safe
with minimal side effects in clinical studies of hundreds of
patients in a program targeting a different indication by
AstraZeneca. The combination of safety, tolerability and efficacy
in an established translationally relevant epilepsy model support
BAER-101’s continued development. The selective potentiation of
alpha 2,3-containing GABA-A receptors with minimal impact on α1 and
α5-containing GABA-A receptors differentiates BAER-101 from
competitors, and predicts a lower potential for sedation, motor
incoordination, cognitive impairment and/or tolerance. Further
study of the anti-seizure properties of BAER-101 is being planned
in patients with focal seizures and other seizure disorders for
which current treatments are not fully efficacious.
“As an experienced neurologist treating patients
with epilepsy, I believe the potency, tolerability and efficacy of
BAER-101 is exciting, as it creates an opportunity to improve the
treatment of seizures in a field where many of the approved
treatments have limited efficacy and/or are dose-limited by side
effects,” said Amy Chappell, M.D., FAAN, experienced neuroscience
drug developer, former Eli Lilly and Company executive, and
consultant to the Company.
The detailed study results are expected to be
presented at an upcoming scientific meeting.
About BAER-101Avenue is
developing BAER-101 via its subsidiary Baergic Bio for epilepsy
disorders. BAER-101 is a PAM of α2,3 subunit‐containing
GABA-A receptors with minimal activity at α1 or α5‐containing
receptors, which are believed to mediate many of the issues
impacting the medical use of benzodiazepines such as those noted
with diazepam use (tolerance, dependence, abuse, sedation and
impaired cognition). As a result, BAER-101 may have the potential
to treat epilepsy, anxiety and other disorders in which
benzodiazepines are currently used, while minimizing the
benzodiazepine associated adverse effects. BAER-101 was licensed in
from AstraZeneca with a large safety database in over 700 patients
and an efficacy signal in a subset of patients with anxiety.
About EpilepsyAbsence
epilepsy is a form of epileptic syndrome where patients
show generalized non-convulsive seizures characterized by a brief
unresponsiveness to environmental stimuli and cessation of
activity. In human, typical absence seizures are associated with
bilateral, synchronous and regular spike-and-wave discharges
(“SWD”). SynapCell's world-exclusive model, the GAERS, displays
spontaneous SWD and has become the “state of the art” translational
a reference model for the past thirty years. Most of the drugs
that have been studied in the GAERS model work in focal as well as
generalized seizures in humans.
About Avenue TherapeuticsAvenue
Therapeutics, Inc. (Nasdaq: ATXI) is a specialty pharmaceutical
company focused on the development and commercialization of
therapies for the treatment of neurologic diseases. The Company is
currently developing three assets including AJ201, a first-in-class
asset for spinal and bulbar muscular atrophy, BAER-101, an oral
small molecule selective GABA-A α2/3 receptor positive allosteric
modulator for CNS diseases, and IV Tramadol, which is in Phase 3
clinical development for the management of
moderate-to-moderately-severe pain in adults in a medically
supervised healthcare setting. Avenue is headquartered in Miami, FL
and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more
information, visit www.avenuetx.com.
Forward-Looking StatementsThis
press release contains predictive or “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act
of 1995. All statements other than statements of current or
historical fact contained in this press release, including
statements that express our intentions, plans, objectives, beliefs,
expectations, strategies, predictions or any other statements
relating to our future activities or other future events or
conditions are forward-looking statements. The words “anticipate,”
“believe,” “continue,” “could,” “estimate,” “expect,” “intend,”
“may,” “plan,” “predict,” “project,” “will,” “should,” “would” and
similar expressions are intended to identify forward-looking
statements. These statements are based on current expectations,
estimates and projections made by management about our business,
our industry and other conditions affecting our financial
condition, results of operations or business prospects. These
statements are not guarantees of future performance and involve
risks, uncertainties and assumptions that are difficult to predict.
Therefore, actual outcomes and results may differ materially from
what is expressed or forecasted in, or implied by, the
forward-looking statements due to numerous risks and uncertainties.
Factors that could cause such outcomes and results to differ
include, but are not limited to, risks and uncertainties arising
from: expectations for increases or decreases in expenses;
expectations for the clinical and pre-clinical development,
manufacturing, regulatory approval, and commercialization of our
pharmaceutical product candidate or any other products we may
acquire or in-license; our use of clinical research centers and
other contractors; expectations for incurring capital expenditures
to expand our research and development and manufacturing
capabilities; expectations for generating revenue or becoming
profitable on a sustained basis; expectations or ability to enter
into marketing and other partnership agreements; expectations or
ability to enter into product acquisition and in-licensing
transactions; expectations or ability to build our own commercial
infrastructure to manufacture, market and sell our product
candidates; acceptance of our products by doctors, patients or
payors; our ability to compete against other companies and research
institutions; our ability to secure adequate protection for our
intellectual property; our ability to attract and retain key
personnel; availability of reimbursement for our products;
estimates of the sufficiency of our existing cash and cash
equivalents and investments to finance our operating requirements,
including expectations regarding the value and liquidity of our
investments; the volatility of our stock price; expected losses;
expectations for future capital requirements; and those risks
discussed in our filings which we make with the SEC. Any
forward-looking statements speak only as of the date on which they
are made, and we undertake no obligation to publicly update or
revise any forward-looking statements to reflect events or
circumstances that may arise after the date of this press release,
except as required by applicable law. Investors should evaluate any
statements made by us in light of these important factors.
Contact: Jaclyn Jaffe Avenue Therapeutics, Inc.
(781) 652-4500ir@avenuetx.com
Grafico Azioni Avenue Therapeutics (NASDAQ:ATXI)
Storico
Da Apr 2024 a Mag 2024
Grafico Azioni Avenue Therapeutics (NASDAQ:ATXI)
Storico
Da Mag 2023 a Mag 2024