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Auxilius's Clinical Trial Results for AUX-001 Show Promise in Combatting Chronic Angina


21 March 2024

Auxilius Pharma's clinical trial of AUX-001, a novel extended-release formulation of nicorandil for treating chronic stable angina, has shown promising results in extending the drug's half-life and ensuring safety and tolerability. The recently unveiled successful Phase 1a study represents a significant milestone, marking the top-line results of its first-in-human clinical trial for AUX-001. This innovative oral medication is poised to revolutionize the treatment landscape for chronic angina.

A Breakthrough in Angina Management

AUX-001, an extended-release formulation of nicorandil, has completed its exploratory Phase 1a pharmacokinetics study with flying colors, setting the stage for a new era in angina management. Conducted in Portugal with 16 healthy volunteers, the study aimed to understand how the body processes the medication and to evaluate its safety and tolerability.

The findings are nothing short of promising. AUX-001 significantly extended the half-life of nicorandil - from the standard 49±8 minutes seen with the immediate-release version to over 9 hours. “A result like this bodes well for AUX-001’s potential to extend daylong coverage of its anti-ischemic effect with just one capsule a day,” commented Dawid Chabowski, Science and Operational Manager at Auxilius Pharma.

Safety and Tolerability

Safety is paramount in the development of any new medication. AUX-001 demonstrated an admirable safety profile, with common side effects such as headaches being effectively managed with over-the-counter remedies. This preemptive approach to side effect management resulted in no patient dropouts due to headaches - a notable achievement given the commonality of this issue with vasodilator medications.

"Headaches upon treatment initiation with nicorandil can lead 15 to 30% of patients to leave any trial. Ours is probably one of very few angina studies using oral nicorandil with no headache related patient dropouts, thanks to our preemptive management and proactive patient communication," stated Uwe Tigör, MD, Chief Medical Officer at Auxilius.

This patient-centric approach could set a new standard in clinical trials, especially for conditions like chronic angina where medication adherence is crucial.

Looking Towards a Future

The successful trial marks just the beginning for AUX-001. Auxilius Pharma is now setting its sights on further clinical development and seeking partnerships to bring this groundbreaking medication to market. With a collaborative agreement already in place with the FDA and a unique 505(b)2 regulatory pathway, AUX-001 could soon offer a new hope for the over 11 million patients in the US suffering from chronic stable angina.

Chronic stable angina, a manifestation of coronary artery disease, leads to chest pain and discomfort triggered by physical exertion or emotional stress. Despite the availability of treatments, the search for innovative and effective medications has been slow. AUX-001, with its potential for once-daily dosing and sustained symptom relief, stands out as a beacon of innovation.

Auxilius Pharma's commitment to enhancing cardiac care is clear. As the company moves forward with its IND filing and seeks partnerships, the future for AUX-001 and its impact on angina treatment in the US looks brighter than ever.

About Chronic Stable Angina

Chronic Stable Angina Pectoris affects millions worldwide, causing chest pain due to reduced blood flow to the heart. With new cases on the rise annually in the US, the demand for effective treatments has never been higher. AUX-001's development represents a significant step forward in meeting this need, promising a future where angina's grip on patients' lives is significantly loosened.


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