The drug is aimed at treating chronic stable angina pectoris and conducted in Portugal, the exploratory phase 1a pharmacokinetics study, involving 16 healthy adult volunteers, concluded just before the end of last year (2023).
The study focused on evaluating the pharmacokinetics of AUX-001, an oral, extended-release, once-daily version of nicorandil, a medication used to treat angina. Additionally, it aimed to assess the safety and tolerability of the investigational anti-anginal drug.
The topline results of the study demonstrated that AUX-001 effectively prolonged the half-life of nicorandil from the standard 49±8 minutes, as observed with the current immediate-release form administered twice daily, to over nine hours.
Dawid Chabowski, science and operational manager at Auxilius Pharma, said: “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.”
The study revealed that AUX-001 was well-tolerated by participants, with headaches being the most common adverse event.
Auxilius chief medical officer, Uwe Tigör, emphasized the significance of managing headaches, he said: “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.”
The successful outcomes of this trial mark a significant milestone for Auxilius Pharma's R&D efforts. CEO Jed Litwiniuk is confident in the trial's results. He said: “We are reassured by the outcomes of the trial.”
Auxilius Pharma's strategic move to introduce AUX-001 to the US market via the 505(b)2 regulatory pathway is poised to revolutionize cardiac care. With AUX-001 anticipated to gain up to five years of market exclusivity upon approval, coupled with comprehensive intellectual property rights secured globally, it is positioned to significantly impact the treatment landscape for chronic angina in the United States and beyond.
Chronic Stable Angina Pectoris (CSAP) is one of the most common cardiovascular conditions affecting over 11 million patients in the US. It is a common manifestation of atherosclerotic coronary artery disease (CAD), marked by chest pain or discomfort due to reduced myocardial blood flow, usually triggered by physical exertion, emotional stress, or other factors.
CSAP prevalence is significant and growing, with around 650.000 new cases annually in the US. Standard of care for most patients with stable coronary artery disease underlying their chronic angina optimized medical therapy with anti-anginal medications.
Litwiniuk has announced plans for an IND filing for AUX-001 later this year and said the company is actively seeking partnerships with mid- to large-size pharmaceutical companies to advance the clinical development of AUX-001.
AUX-001 offers efficacy comparable to conventional anti-anginal medications such as beta-blockers, calcium channel blockers, and long-acting nitrates while also potentially enhancing control of the underlying coronary disease and reducing angina related hospitalizations.
