Applied Therapeutics Announces Multiple Data Presentations at the American Heart Association Scientific Sessions November 5-7, 2022

Rhea-AI Summary

Applied Therapeutics (Nasdaq: APLT) reported promising preclinical data supporting its investigational treatment, AT-001, for Diabetic Cardiomyopathy. Key findings show AT-001 effectively reduces cardiac fibrosis and prevents adverse remodeling. The ongoing Phase 3 ARISE-HF study emphasizes the importance of cardiac functional capacity, measured by Peak VO2, for patients' quality of life. This data will be presented at the American Heart Association Scientific Sessions from November 5-7, 2022, alongside additional insights into Diabetic Cardiomyopathy's diagnosis and prevalence.

Positive

• Effective reduction of cardiac fibrosis and adverse remodeling through AT-001, based on preclinical data.
• ARISE-HF study highlights the correlation between cardiac functional capacity and quality of life for Diabetic Cardiomyopathy patients.

Negative

• None.

• Additional preclinical data supports AT-001 as an effective treatment for Diabetic Cardiomyopathy, reducing cardiac fibrosis and adverse remodeling
• Baseline analysis of Phase 3 ARISE-HF study supports the primary endpoint (cardiac functional capacity as measured by Peak VO2) as an important metric of quality of life and physical functioning in Diabetic Cardiomyopathy patients

NEW YORK, Oct. 31, 2022 (GLOBE NEWSWIRE) -- 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 Lopaschuk
Saturday, 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 Study
Alessia 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 Pandey
Sunday, November 6, 2022, 10:30am-11:30am (poster) SU3001

Machine Learning-based Approaches to Identify Diabetic Cardiomyopathy
Kershaw Patel, Matthew Segar, Muthiah Vaduganathan, Wai Hong, Wilson Tang, Dwayne Willett, Ambarish Pandey
Sunday, November 6, 2022, 10:30am-11:30am (poster) SU3001

About AT-001
AT-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 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, 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 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. 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 or
appliedtherapeutics@argotpartners.com

Media:
media@appliedtherapeutics.com

Applied Therapeutics, Inc.

FAQ

What recent data has been presented for APLT regarding AT-001?

Applied Therapeutics has shown preclinical data supporting AT-001 as an effective treatment for Diabetic Cardiomyopathy, reducing cardiac fibrosis and adverse remodeling.

What does the Phase 3 ARISE-HF study focus on for APLT?

The Phase 3 ARISE-HF study focuses on the correlation of cardiac functional capacity, measured by Peak VO2, with quality of life in Diabetic Cardiomyopathy patients.

When will the data on APLT's AT-001 be presented?

Data on AT-001 will be presented at the American Heart Association Scientific Sessions from November 5-7, 2022.

What is AT-001 being developed for by APLT?

AT-001 is being developed as a treatment for Diabetic Cardiomyopathy.