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 multiple data
presentations at the upcoming American Heart Association Scientific
Sessions, to be held November 5-7, 2022 in Chicago, IL. Data to be
presented includes mechanistic support for AT-001 in a Diabetic
Cardiomyopathy mouse model, demonstrating that AT-001 treatment
prevents fibrosis and adverse cardiac remodeling; baseline data
from the ongoing Phase 3 ARISE-HF study on quality of life impact
of disease and correlation of cardiac functional capacity (peak
VO2) with physical function; additional DbCM diagnosis and
prevalence data.
Presentation Details
Aldose Reductase Inhibition by
AT-001 Alleviates Fibrosis and Adverse Remodeling in Diabetic
Cardiomyopathy by Reducing Myocardial Fatty Acid
Oxidation Keshav Gopal, Qutuba G Karwi, S. Amirhossein
Tabatabaei-Dakhili, Cory S Wagg, Liyan Zhang, Qiuyu Sun, Christina
T Saed, Sai Panidarapu, Riccardo Perfetti, Ravichandran Ramasamy,
John R Ussher, Gary D LopaschukSaturday, November 5, 2022, (oral
presentation) LBBS11
Diabetic Cardiomyopathy is Associated
with Worsening of Quality of Life Long Before the Development of
Overt Heart Failure: Lessons From the Baseline Analysis of the
ARISE-HF StudyAlessia Urbinati, Riccardo Perfetti, Stella
Wang, Sariah Persaud, Shoshana Shendelman, James L Januzzi
Jr.Sunday, November 6, 2022, 3:45pm-4:45pm (poster) SU2230
Association of WATCH-DM Risk Score with
Cardiac Abnormalities and Prevalence of Diabetic Cardiomyopathy: A
Prospective Cohort Study Zainali Chunawala, Viraj Raygor,
Matthew Segar, Alvin Chandra, Ambarish PandeySunday, November 6,
2022, 10:30am-11:30am (poster) SU3001
Machine Learning-based Approaches to
Identify Diabetic CardiomyopathyKershaw Patel, Matthew
Segar, Muthiah Vaduganathan, Wai Hong, Wilson Tang, Dwayne Willett,
Ambarish PandeySunday, November 6, 2022, 10:30am-11:30am (poster)
SU3001
About AT-001AT-001 is an
investigational oral, novel, potent Aldose Reductase inhibitor in
Phase 3 clinical development for the treatment of Diabetic
Cardiomyopathy. The global ARISE-HF study is currently ongoing, and
is designed to evaluate 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. 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
TherapeuticsApplied 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, AT-007,
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 StatementsThis
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 strategy, future operations,
prospects, plans and objectives of management, including words such
as “may,” “will,” “expect,” “anticipate,” “plan,” “intend,” 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 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, (vi) our ability to maintain and
establish collaborations or obtain additional funding, (vii) our
ability to obtain regulatory approval of our current and future
product candidates, (viii) our expectations regarding the potential
market size and the rate and degree of market acceptance of such
product candidates, (ix) our ability to fund our working capital
requirements and expectations regarding the sufficiency of our
capital resources, (x) the implementation of our business model and
strategic plans for our business and product candidates, (xi) our
intellectual property position and the duration of our patent
rights, (xii) developments or disputes concerning our intellectual
property or other proprietary rights, (xiii) our expectations
regarding government and third-party payor coverage and
reimbursement, (xiv) our ability to compete in the markets we
serve, (xv) the impact of government laws and regulations and
liabilities thereunder, (xvi) developments relating to our
competitors and our industry, (xvii) the impact of the COVID-19
pandemic on the timing and progress of our ongoing clinical trials
and our business in general and (xviii) 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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