Cardurion to Present Phase 2 Results for PDE9 Inhibitor Tovinontrine in Both Major Types of Heart Failure
核心洞察
Cardurion Pharmaceuticals will present Phase 2 CYCLE trial results for tovinontrine (CRD-750), a novel PDE9 inhibitor, at the HFSA Annual Scientific Meeting in Phoenix, Arizona, October 9–12, 2026.
Tovinontrine is an orally administered PDE9 inhibitor that enhances the natriuretic peptide signaling pathway, and Cardurion is the first company to bring a PDE9 inhibitor into clinical development for chronic heart failure (搜索).
The global, multi-center Phase 2 trials (NCT06215911 and NCT06215586) assess safety and efficacy in both heart failure with reduced ejection fraction (HFrEF) (搜索) and preserved ejection fraction (HFpEF).
Cardurion Pharmaceuticals, Inc., a clinical-stage biotechnology company focused on cardiovascular diseases, announced that it will present results from its Phase 2 CYCLE clinical trials evaluating tovinontrine (CRD-750), a novel phosphodiesterase-9 (PDE9) (搜索) inhibitor, in chronic heart failure (搜索). The results will be delivered in late-breaking presentations at the Heart Failure Society of America (HFSA) Annual Scientific Meeting in Phoenix, Arizona, taking place October 9–12, 2026.
Tovinontrine is an orally administered PDE9 inhibitor that represents a new mechanism to enhance the natriuretic peptide signaling (NPS) pathway, a clinically validated pathway for the treatment of patients with heart failure (搜索). Cardurion is the first company to bring a PDE9 inhibitor into clinical development for the treatment of chronic heart failure.
"We look forward to sharing the exciting results from our CYCLE trials, which represent the first time that robust Phase 2 data have been completed for PDE9 inhibition in heart failure (搜索). Despite current standard of care, a large unmet medical need remains, and patients with chronic heart failure continue to experience high rates of morbidity and mortality," said Howard Surks, MD, Chief Medical and Scientific Officer of Cardurion. "It is a major milestone for our company to successfully complete this large, global clinical program in both major types of heart failure, and the results of the CYCLE studies will guide the next stage of clinical development for tovinontrine as we move closer to our goal of bringing this novel PDE9 inhibitor to patients with chronic heart failure."
The CYCLE Clinical Program
The presentations at HFSA will describe results from Cardurion's global, multi-center, Phase 2 clinical trials assessing the safety and efficacy of tovinontrine in the two major types of chronic heart failure (搜索): heart failure with reduced ejection fraction (HFrEF) (搜索) and heart failure with preserved ejection fraction (HFpEF) (搜索).
The CYCLE-1 REF trial (NCT06215911) is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study assessing the safety and effectiveness of tovinontrine in patients with chronic heart failure (搜索) with reduced ejection fraction. The CYCLE-2 PEF trial (NCT06215586) is a Phase 2, randomized, double-blind, placebo-controlled clinical study assessing the safety and effectiveness of tovinontrine in patients with chronic heart failure with preserved ejection fraction.
Mechanism of PDE9 Inhibition
Phosphodiesterase 9 is an enzyme whose elevated activity in patients with heart failure (搜索) reduces the beneficial effects of the natriuretic peptide signaling (NPS) pathway. The NPS pathway plays an important and protective role in cardiac function, and its activation has been shown to confer outcomes benefit for patients with heart failure. PDE9 is significantly upregulated in patients with chronic heart failure, causing disruption in the NPS pathway. Cardurion is the first company to demonstrate clinical proof-of-mechanism for PDE9 inhibition in patients with chronic heart failure with its PDE9 program.
Disease Burden and Unmet Need
Heart failure (搜索) is a prevalent and growing condition responsible for substantial morbidity and mortality. Approximately 6.7 million adults in the United States suffer from heart failure, and approximately 50 percent of these patients die from the condition within five years of diagnosis. One in five patients with heart failure are hospitalized annually, and approximately 25 percent of these patients are re-admitted within a month of discharge.
Approximately half of all patients with chronic heart failure (搜索) have reduced ejection fraction (HFrEF) and half have preserved ejection fraction (HFpEF), categorized as different diseases based on the pumping ability of the heart. Significant unmet medical needs remain in heart failure, despite the reductions in morbidity and mortality from currently approved treatments for heart failure.
About Cardurion Pharmaceuticals
Cardurion Pharmaceuticals is a clinical-stage biotechnology company discovering and developing new therapeutic approaches to address cardiovascular diseases. Its clinical-stage pipeline consists of product candidates targeting phosphodiesterase-9 (PDE9) (搜索) and calcium/calmodulin-dependent protein kinase II (CaMKII) (搜索). Cardurion is the first company to advance product candidates against these novel and important targets into clinical testing for the treatment of cardiovascular disease. Cardurion is headquartered in Burlington, Massachusetts, with discovery sciences and research facilities in Shonan, Japan.