BOULDER, Colo. - Edgewise Therapeutics, Inc. (NASDAQ:EWTX), a biopharmaceutical company focusing on muscle diseases, today shared top-line results from the Phase 1 and Phase 2 trials of its investigational drug, EDG-7500, for the treatment of hypertrophic cardiomyopathy (HCM). The trials showed that EDG-7500 was well-tolerated and led to significant reductions in left ventricular outflow tract (LVOT) gradients in patients with obstructive HCM, without meaningful changes in left ventricle ejection fraction (LVEF).
The Phase 1 trial involved 48 healthy subjects who received single ascending doses of EDG-7500, ranging from 5 to 300 mg, and demonstrated that the drug was well-tolerated. Similarly, in the Phase 2 CIRRUS-HCM trial, patients with obstructive HCM received single doses of 50, 100, or 200 mg of EDG-7500, resulting in a 67% mean reduction in resting LVOT pressure gradient and a 55% mean reduction in provocable LVOT gradient for the 100 and 200 mg doses.
Importantly, across both studies, no subjects experienced a reduction in LVEF to below 50%, indicating that the drug does not adversely affect this critical measure of heart function. Additionally, treatment with a single dose of 200 mg of EDG-7500 led to a 64% mean reduction in NT-proBNP, a biomarker of heart failure.
Based on these findings, Edgewise has initiated a 28-day trial in patients with both obstructive and non-obstructive HCM. The company plans to continue evaluating the drug's tolerability, pharmacokinetics, and effects on LVOT gradient, LVEF, biomarkers, and measures of feel and function.
Dr. Anjali T. Owens of the University of Pennsylvania, a CIRRUS-HCM Investigator, emphasized the unmet need for patients with obstructive and non-obstructive HCM and expressed enthusiasm for the ongoing trial of this novel treatment.
Edgewise expects to report initial data from the 28-day trial in the first quarter of 2025. Today, the company will host a webcast event at 8:30 a.m. Eastern Time to discuss the trial data, featuring insights from Dr. Owens.
EDG-7500 is a novel oral, selective cardiac sarcomere modulator designed to slow early contraction velocity and address impaired cardiac relaxation associated with HCM and other diastolic dysfunction diseases.
This article is based on a press release statement.
In other recent news, Edgewise Therapeutics revealed preliminary data from Phase 1 and 2 clinical trials of its heart disease drug, EDG-7500. Findings from the trials will be discussed in an upcoming webcast. The drug is intended to enhance cardiac relaxation in conditions of diastolic dysfunction, such as hypertrophic cardiomyopathy (HCM), a condition characterized by the thickening of the heart muscle. The company also announced the approval of the 2024 Inducement Equity Incentive Plan, reserving 2 million shares of common stock for new equity awards.
Piper Sandler maintained its Overweight rating on Edgewise, citing upcoming milestones such as the Phase 1 trials for EDG-7500 and anticipated presentations at the Heart Failure Society of America meeting. The company is also preparing for data readouts from its sevasemten programs in Phase 2 trials by the end of 2024. These developments underscore Edgewise's commitment to advancing its pipeline of innovative therapeutics.
InvestingPro Insights
As Edgewise Therapeutics, Inc. (NASDAQ:EWTX) announces promising trial results for its drug EDG-7500, investors and stakeholders may find the following InvestingPro data and tips pertinent to understanding the company's financial health and market performance. Edgewise holds a market capitalization of $1.79 billion, reflecting its valuation in the biopharmaceutical landscape. Despite its innovation in drug development, the company does not pay dividends, focusing its resources on research and growth. InvestingPro data shows a significant one-year price total return of 209.08%, indicating robust investor confidence over the past year, likely buoyed by the company's clinical advancements.
However, it's important to note that analysts have tempered expectations, with four analysts revising their earnings downwards for the upcoming period. This could reflect the inherent risks and uncertainties in drug development pipelines. Additionally, while Edgewise has demonstrated strong returns in the short term, with an 8.54% return over the last week and a 17.86% return over the last three months, the company's P/E ratio stands at -12.7, underscoring that it is not currently profitable. This is further supported by an adjusted P/E ratio of -15.43 for the last twelve months as of Q2 2024, and a negative operating income of $136.17 million USD for the same period.
InvestingPro Tips highlight that while Edgewise has more cash than debt, suggesting a solid liquidity position, it suffers from weak gross profit margins and is not anticipated to be profitable this year. Nevertheless, with liquid assets exceeding short-term obligations, the company maintains a degree of financial flexibility to support ongoing clinical trials. For those interested in a deeper dive, there are additional InvestingPro Tips available that can provide more nuanced insights into Edgewise's financial metrics and performance indicators.
For investors considering Edgewise's potential, these financial metrics and InvestingPro Tips can help paint a comprehensive picture of the company's standing, beyond the promising clinical trial results. For further information and analysis, investors can explore https://www.investing.com/pro/EWTX.
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