NEW YORK - Applied Therapeutics, Inc. (NASDAQ:APLT), a clinical-stage biopharmaceutical company, is set to present comprehensive results from its Phase 3 ARISE-HF study at the American College of Cardiology Annual Scientific Session in Atlanta. The study evaluated AT-001, an investigational treatment for Diabetic Cardiomyopathy (DbCM), and will be shared on Monday.
The ARISE-HF study previously reported in January 2024 that AT-001 showed a significant trend in stabilizing cardiac function in a specific subgroup of patients not treated with SGLT2 or GLP-1 inhibitors.
The upcoming presentation will include additional data on the prevention of overt heart failure progression and other secondary outcomes. The study found that AT-001 significantly prevented the progression to overt heart failure compared to a placebo in patients with DbCM (p=0.0285).
Safety data from the trial will also be disclosed, suggesting that AT-001 was safe and well-tolerated among participants. This indicates a potential advancement over previous aldose reductase inhibitors, which have faced selectivity and safety challenges.
AT-001, known as caficrestat, is part of Applied Therapeutics' pipeline targeting molecular mechanisms in diseases with high unmet medical needs. The drug is in Phase 3 development, with the ARISE-HF study involving 675 patients at risk of developing overt heart failure.
The results of the ARISE-HF study are scheduled for simultaneous publication in the Journal of the American College of Cardiology (JACC) on the day of the presentation.
Applied Therapeutics focuses on novel therapies for validated molecular targets, including govorestat for CNS rare metabolic diseases and AT-003 for Diabetic retinopathy.
The information in this article is based on a press release statement and does not constitute an endorsement of the company or its potential product. Investors and the public are urged to consider that the company's forward-looking statements involve risks and uncertainties.
InvestingPro Insights
As Applied Therapeutics (NASDAQ:APLT) gears up for a significant presentation of its Phase 3 ARISE-HF study results, investors are closely monitoring the company's performance metrics and market behavior. According to real-time data from InvestingPro, Applied Therapeutics has a market capitalization of 657.56 million USD, reflecting its position in the biopharmaceutical sector. Despite the anticipation surrounding the potential of AT-001, the company's stock has experienced high volatility, as indicated by a one-week price total return of -8.68% and a significant six-month price total return of 179.1%.
InvestingPro Tips suggest that Applied Therapeutics generally trades with high price volatility, which may be a point of consideration for investors looking at the short-term price movements. Additionally, the company's short-term obligations exceeding its liquid assets could be a financial health indicator that warrants attention. With analysts not anticipating the company to be profitable this year, the focus remains on the long-term potential of its pipeline products like AT-001.
Investors interested in a deeper analysis of Applied Therapeutics can explore more InvestingPro Tips, which include insights on the company's profitability, debt levels, and valuation multiples. For those considering a subscription, use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription. There are currently 12 additional InvestingPro Tips available for Applied Therapeutics, which can be accessed at https://www.investing.com/pro/APLT for those seeking comprehensive investment analysis.
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