Transforming Angina Treatment

Chronic Stable Angina Pectoris (CSAP) affects over 11 million patients in the U.S. and 16 million in the EU, significantly impacting their quality of life and daily activities. Despite its prevalence, innovation in treatment has stagnated for nearly two decades. The last major anti-anginal drug approval was ranolazine in 2006. This stagnation comes despite groundbreaking studies like COURAGE (2007) and ISCHEMIA (2020), which demonstrated that optimal medical therapy (OMT) could match invasive procedures such as Percutaneous Coronary Intervention (PCI) and Coronary Artery Bypass Grafting (CABG) in terms of outcomes for CSAP patients while offering significant advantages in terms of cost, mortality risk, and patient recovery.

However, symptom control remains inadequate for many CSAP sufferers. The average patient in the U.S. requires two or more anti-anginal medications, and even then, many still experience debilitating symptoms. This highlights a critical unmet need in the treatment of CSAP, particularly as no new therapies are currently in the U.S. pipeline, leaving fewer treatment options than are available in the European Union and other regions. Auxilius Pharma is dedicated to addressing this gap with AUX-001, a novel extended-release (ER) formulation of nicorandil designed to offer sustained relief with a once-daily dose.

The Need for Tailored, Patient-Centric Approaches

The 2024 ESC Guidelines for angina management emphasize a move away from hierarchical treatment paradigms. They recommend individualizing therapy based on each patient’s unique profile, including comorbidities, hemodynamic parameters, and the underlying mechanisms of myocardial ischemia. This shift acknowledges the diversity of angina presentations—ranging from epicardial coronary artery obstruction to microvascular dysfunction—and the varied patient responses to medications.

For many patients, a combination of anti-anginal drugs is essential to achieve adequate symptom control. While traditional therapies such as beta-blockers and calcium channel blockers (CCBs) remain first-line options, newer agents like nicorandil, ranolazine, and ivabradine play an increasingly important role as second-line therapies or as part of upfront combination regimens. Unfortunately, direct comparisons between these medications are limited, leaving clinicians with little guidance on the most effective combinations or sequencing.

AUX-001: Bridging the Gap in Treatment

AUX-001 represents a significant advancement in addressing both the symptoms and underlying pathophysiology of CSAP. Unlike other anti-anginals that focus solely on symptom management, nicorandil’s dual mechanism of action—combining nitrate-like effects with potassium channel activation—provides a well-balanced vasodilatory effect. This unique profile allows AUX-001 to:

1. Deliver consistent symptom relief with minimal risk of tolerance, a common issue with long-acting nitrates.

2. Support hemodynamic stability, avoiding complications like hypotension, which limit the use of other vasodilators.

3. Address specific subgroups of angina patients, such as those with: (a) microvascular angina, where endothelial dysfunction plays a key role; and (b) congestive heart failure, for which no dedicated anti-anginal therapies currently exist.

Although nicorandil is widely used in Japan, China, and Europe, its immediate-release formulation requires two to three doses per day and has been hindered by formulation challenges, preventing its approval in the U.S. AUX-001’s once-daily extended-release formulation overcomes these barriers, making it a promising candidate to redefine angina management in the U.S. market.

Wny Now?

The stagnation in innovation for CSAP is particularly troubling given that nearly half of patients on OMT still report significant symptom burdens. As chronic angina remains a complex and multifactorial disease, a one-size-fits-all approach is insufficient. Auxilius Pharma’s introduction of AUX-001 aligns with the ESC’s call for tailored therapies, offering clinicians a versatile tool to customize treatment based on individual patient needs.

Looking Ahead

Auxilius Pharma’s vision extends beyond symptom management to improving overall cardiovascular outcomes. While beta-blockers remain the only anti-anginal class with demonstrated long-term benefits in certain contexts (e.g., post-myocardial infarction), AUX-001 holds the potential to fill a critical void by addressing both symptoms and the progression of ischemic coronary disease. By leveraging the latest advancements in formulation science and adhering to patient-centric principles, Auxilius Pharma aims to set a new standard in the treatment of chronic stable angina pectoris.

AUX-001 isn’t just another medication—it’s a new approach to holistic, individualized care for a condition that has seen far too little innovation.