AnaCardio Secures US Patent for Heart Failure Drug AC01, Extending Protection Until 2042
核心洞察
AnaCardio (搜索) and Helsinn Healthcare (搜索) received US Patent No. 12,569,476 covering AC01 for treating heart failure with reduced ejection fraction, providing protection until June 2, 2042.
AC01 is a first-in-class oral calcium sensitizing inotrope that recently demonstrated favorable safety and tolerability in a Phase 1b/2a trial with proof-of-concept in HFrEF patients.
The patent strengthens intellectual property protection for AC01 in the world's largest pharmaceutical market, supporting continued development for a significant unmet medical need in cardiovascular medicine.
AnaCardio (搜索) AB and Helsinn Healthcare (搜索) SA announced that the United States Patent and Trademark Office has issued US Patent No. 12,569,476, covering the use of AC01 for treating heart failure with reduced ejection fraction (HFrEF). The patent, co-owned by both companies, provides protection in the United States until June 2, 2042, plus potential patent term extensions.
Novel Mechanism for Heart Failure Treatment
AC01 represents a first-in-class calcium sensitizing inotrope developed as an oral ghrelin mimetic small-molecule. The drug candidate was originally in-licensed from Helsinn and is being developed by AnaCardio (搜索) as a contractile agent for heart failure patients. The compound was founded on ground-breaking research from Karolinska Institutet demonstrating improved contractility of the heart muscle through a unique and differentiated mechanism.
Clinical Development Progress
AnaCardio (搜索) recently completed a successful Phase 1b/2a trial with AC01 that generated proof-of-concept in patients with HFrEF. In December 2025, the company's lead asset demonstrated a favorable safety and tolerability profile in the Phase 2a clinical study, supporting further development of this promising oral drug candidate in patients with advanced heart failure.
Strategic Significance and Market Impact
"This newly issued U.S. patent significantly strengthens the intellectual property protection for AC01 and reinforces the long-term exclusivity we have built around our lead candidate in the world's largest pharmaceutical market," commented Patrik Strömberg, AnaCardio (搜索) CEO. "Together with our broader patent portfolio, it creates a strong and layered IP position supporting AC01 well into the 2040s. We believe AC01 has the potential to become a truly transformative therapy for patients with heart failure and reduced ejection fraction, addressing one of the most significant unmet medical needs in cardiovascular medicine."
Ricardo Braglia, Helsinn Group CEO, added: "We are very pleased with the issuance of this U.S. patent, which significantly strengthens the long-term potential of the AC01 program. This milestone further reinforces the value of our partnership with AnaCardio (搜索) and underlines our commitment to supporting innovative therapies that address major unmet needs in cardiovascular disease."
Investment and Partnership Structure
KDventures (搜索) AB, a Nordic investment company specialized in life sciences, holds a 10 percent ownership stake in AnaCardio (搜索). Viktor Drvota, CEO of KDventures, noted that "this patent bolsters protection for our portfolio company's drug candidate AC01 on the US market and strengthens its commercial potential as well as the prospects for continued clinical development in a therapeutic area with great medical need."
The patent issuance represents a significant milestone for AnaCardio (搜索)'s intellectual property strategy, creating a robust foundation for the continued development and potential commercialization of AC01 in treating heart failure with reduced ejection fraction.