Applied Therapeutics to Present Data Highlighting AT-001 for the Treatment of Diabetic Cardiomyopathy in Late Breaking Sessio...
07 Giugno 2019 - 1:30PM
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 data
at the American Diabetes Association 79th Scientific Sessions in
San Francisco (June 7-11, 2019) on AT-001, a novel, potent and
selective aldose reductase inhibitor (ARI) in clinical development
for Diabetic Cardiomyopathy (DbCM). The Late Breaking Science
poster, entitled “Phase 1/2 Safety and Proof of Biological Activity
Study of AT-001, an Aldose Reductase Inhibitor in Development for
Diabetic Cardiomyopathy” highlights a recently completed Phase 1/2
study in approximately 120 patients with type 2 diabetes, a subset
of which had DbCM.
“Diabetic complications, such as Diabetic
Cardiomyopathy, continue to grow despite advancements in glucose
control. It’s imperative that therapies are developed to treat or
prevent diabetic complications through mechanisms other than
glycemic modification,” said Riccardo Perfetti, MD, PhD. “We
are excited to be presenting our data at the prominent ‘Late
Breaking’ session at ADA, and are thrilled by the recognition from
the congress and the clinical community. Targeting aldose
reductase with a potent and selective inhibitor presents an
opportunity to potentially halt disease progression and prevent
worsening of heart failure in DbCM patients. We look forward
to initiating our pivotal program for AT-001 in DbCM later this
year.”
Phase 1/2 Safety and Proof of Biological
Activity Study of AT-001, an Aldose Reductase Inhibitor in
Development for Diabetic Cardiomyopathy(Late Breaking
Abstract – oral poster presentation Sunday, June 9, 12-1pm)
- AT-001 was well tolerated at all
doses tested
- Target engagement was confirmed by
potent aldose reductase (AR) inhibition as evidenced by significant
reductions in sorbitol, a pharmacodynamic biomarker of AR
activity
- AT-001 improved selectivity and
affinity for AR resulted in potent AR inhibition
About Diabetic Cardiomyopathy
Diabetic Cardiomyopathy (DbCM) is a rapidly progressing
degenerative disorder of the heart muscle in people with diabetes.
There are no approved therapies for this fatal condition, which
affects 17 – 24 percent of people with diabetes, or approximately
77 million patients worldwide. Hyperglycemia, a symptom that
characterizes diabetes, triggers the enzyme Aldose Reductase to
convert excess glucose into sorbitol and fructose, both of which
can lead to cell death in the heart muscle. When this happens, the
heart fibroses, or “hardens,” such that the organ is unable to
circulate blood through the body effectively. Approximately 25
percent of patients with DbCM progress to overt heart failure or
death within 1.5 years of diagnosis.
About AT-001AT-001 is an
investigational oral, novel, potent Aldose Reductase inhibitor in
clinical development for the treatment of Diabetic
Cardiomyopathy. AT-001 has been 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-001,
is a novel aldose reductase inhibitor (ARI) that is being developed
for the treatment of Diabetic Cardiomyopathy, or DbCM, a fatal
fibrosis of the heart. The company plans to initiate a Phase 2/3
pivotal study in DbCM in 2019. Applied Therapeutics is also
developing AT-007, a central nervous system penetrant ARI, for the
treatment of Galactosemia, a rare pediatric metabolic disease,
which is expected to advance into a Phase 1 clinical trial in 2019.
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, expected to advance into a Phase
1 study in 2020.
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. These include, without limitation,
statements regarding the likelihood data will support future
development and the expected timing of initiation of our clinical
trials. 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, the uncertainties inherent in the initiation, execution
and completion of clinical trials, in the timing of availability of
trial data, in the results of the clinical trials, in the actions
of regulatory agencies, in the commercialization and acceptance of
new therapies. Other 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 section
titled “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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