Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage
biopharmaceutical company developing a pipeline of novel drug
candidates against validated molecular targets in indications of
high unmet medical need, today announced that it will present full
results from the Phase 3 ARISE-HF study evaluating AT-001
(caficrestat) in Diabetic Cardiomyopathy (DbCM) in an oral
presentation at the 2024 American College of Cardiology (ACC)
Annual Scientific Session to take place April 6-8, 2024 in Atlanta,
Georgia.
The Company announced topline results from
ARISE-HF in January 2024, demonstrating a strong trend in
stabilizing cardiac functional capacity with AT-001 treatment, and
a statistically significant difference in cardiac functional
capacity in a prespecified subgroup of patients not receiving
concomitant treatment with an SGLT2 or GLP-1 while preventing
clinically significant worsening. The presentation at ACC will also
include important data on progression to overt heart failure and
other secondary outcome measures. AT-001 treatment prevented
progression to overt heart failure in patients with DbCM as
compared to placebo (p=0.0285). Detailed safety data will also be
presented, demonstrating that AT-001 was safe and well tolerated in
a large cohort of patients, providing proof of concept that the
technology has overcome the selectivity and safety issues of “old”
aldose reductase inhibitors. The oral presentation at ACC will be
followed by simultaneous publication of the study results in the
Journal of the American College of Cardiology Journal (JACC).
ACC Presentation:
A Selective Aldose Reductase Inhibitor
(AT-001) For the Treatment of Diabetic Cardiomyopathy: Primary
Results of the Phase 3 Randomized Controlled ARISE-HF
Study
James L. Januzzi Jr, Javed Butler, Stefano Del
Prato, Justin A. Ezekowitz, Nasrien E. Ibrahim, Carolyn S.P. Lam,
Gregory D. Lewis, Thomas H. Marwick, Riccardo Perfetti, Julio
Rosenstock, Scott D. Solomon, W.H. Wilson Tang, Faiez Zannad on
behalf of the ARISE-HF Investigators
Monday, April 8, 2024, 8:30 – 9:45 am ET, Main
Tent (Hall B1)
JACC Publication:
Randomized Trial of a Selective Aldose
Reductase Inhibitor in Patients with Diabetic
Cardiomyopathy
James L. Januzzi Jr, Javed Butler, Stefano Del
Prato, Justin A. Ezekowitz, Nasrien E. Ibrahim, Carolyn S.P. Lam,
Gregory D. Lewis, Thomas H. Marwick, Riccardo Perfetti, Julio
Rosenstock, Scott D. Solomon, W.H. Wilson Tang, Faiez Zannad on
behalf of the ARISE-HF Investigators
Journal of the American College of
Cardiology
Published online April 8, 2024
About AT-001 (Caficrestat)
AT-001 (caficrestat) is an investigational oral,
novel, potent Aldose Reductase inhibitor in Phase 3 clinical
development for the treatment of Diabetic Cardiomyopathy. The
global ARISE-HF Phase 3 study evaluated the ability of AT-001 to
improve or prevent worsening of disease, as measured by changes in
cardiac functional capacity, in 675 patients with DbCM at high risk
of progression to overt heart failure. The study demonstrated a
positive impact of AT-001 treatment, which was statistically
significant in a prespecified subgroup of patients not on
concomitant treatment with an SGLT2 or GLP-1 inhibitor. AT-001 has
been previously studied in a Phase 1/2 study in approximately 120
patients with type 2 diabetes, a subset of which had DbCM.
About Applied Therapeutics
Applied Therapeutics is a clinical-stage biopharmaceutical
company developing a pipeline of novel drug candidates against
validated molecular targets in indications of high unmet medical
need. The Company’s lead drug candidate, govorestat, is a novel
central nervous system penetrant Aldose Reductase Inhibitor (ARI)
for the treatment of CNS rare metabolic diseases, including
Galactosemia, SORD Deficiency, and PMM2-CDG. The Company is also
developing AT-001, a novel potent ARI, for the treatment of
Diabetic Cardiomyopathy, or DbCM, a fatal fibrosis of the heart.
The preclinical pipeline also includes AT-003, an ARI designed to
cross through the back of the eye when dosed orally, for the
treatment of Diabetic retinopathy.
To learn more, please visit www.appliedtherapeutics.com and
follow the company on Twitter @Applied_Tx.
Forward-Looking Statements
This press release contains “forward-looking statements” that
involve substantial risks and uncertainties for purposes of the
safe harbor provided by the Private Securities Litigation Reform
Act of 1995. Any statements, other than statements of historical
fact, included in this press release regarding the strategy, future
operations, prospects, plans and objectives of management,
including words such as “may,” “will,” “expect,” “anticipate,”
“plan,” “intend,” “predicts” and similar expressions (as well as
other words or expressions referencing future events, conditions or
circumstances) are forward-looking statements. Forward-looking
statements in this release involve substantial risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied by the forward-looking statements,
and we, therefore cannot assure you that our plans, intentions,
expectations or strategies will be attained or achieved.
Such risks and uncertainties include, without limitation, (i)
our plans to develop, market and commercialize our product
candidates, (ii) the initiation, timing, progress and results of
our current and future preclinical studies and clinical trials and
our research and development programs, (iii) our ability to take
advantage of expedited regulatory pathways for any of our product
candidates, (iv) our estimates regarding expenses, future revenue,
capital requirements and needs for additional financing, (v) our
ability to successfully acquire or license additional product
candidates on reasonable terms and advance product candidates into,
and successfully complete, clinical studies, (vi) our ability to
maintain and establish collaborations or obtain additional funding,
(vii) our ability to obtain and timing of regulatory approval of
our current and future product candidates, (viii) the anticipated
indications for our product candidates, if approved, (ix) our
expectations regarding the potential market size and the rate and
degree of market acceptance of such product candidates, (x) our
ability to fund our working capital requirements and expectations
regarding the sufficiency of our capital resources, (xi) the
implementation of our business model and strategic plans for our
business and product candidates, (xii) our intellectual property
position and the duration of our patent rights, (xiii) developments
or disputes concerning our intellectual property or other
proprietary rights, (xiv) our expectations regarding government and
third-party payor coverage and reimbursement, (xv) our ability to
compete in the markets we serve, (xvi) the impact of government
laws and regulations and liabilities thereunder, (xvii)
developments relating to our competitors and our industry, (xviii)
our ability to achieve the anticipated benefits from the agreements
entered into in connection with our partnership with Advanz Pharma
and (xix) other factors that may impact our financial results. In
light of the significant uncertainties in these forward-looking
statements, you should not rely upon forward-looking statements as
predictions of future events. Although we believe that we have a
reasonable basis for each forward-looking statement contained in
this press release, we cannot guarantee that the future results,
levels of activity, performance or events and circumstances
reflected in the forward-looking statements will be achieved or
occur at all. Factors that may cause actual results to differ from
those expressed or implied in the forward-looking statements in
this press release are discussed in our filings with the U.S.
Securities and Exchange Commission, including the “Risk Factors”
contained therein. Except as otherwise required by law, we disclaim
any intention or obligation to update or revise any forward-looking
statements, which speak only as of the date they were made, whether
as a result of new information, future events or circumstances or
otherwise.
Contacts
Investors:Maeve Conneighton (212) 600-1902
orappliedtherapeutics@argotpartners.com
Media:media@appliedtherapeutics.com
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