Applied Therapeutics to Present Data at ESC-HF Highlighting AT-001, a Novel, Potent and Selective Aldose Reductase Inhibitor for Treatment of Diabetic Cardiomyopathy
“We are excited to be presenting this data in a peer reviewed setting for the first time and are thrilled by the recognition from the congress and the clinical community,” said
Safety and Proof of
- 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
Beneficial Effects of AT-001, an Aldose Reductase Inhibitor, in Rodent Models of Diabetic Cardiomyopathy (
- AT-001 significantly reduced cardiac damage in a relevant mouse model of DbCM, confirming biological activity
- AT-001 normalized sorbitol levels, a biomarker of AR activity, demonstrating effective inhibition of AR
- Data evidences the role of AR inhibition in significantly reducing or preventing cardiac damage and supports clinical investigation of AT-001 in DbCM
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-001
AT-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 an investigational Phase 1/2 study in approximately 120 patients with type 2 diabetes, a subset of which had DbCM.
About
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 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
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Source: Applied Therapeutics