Auxilius Pharma Raises Seed Round of $1 Million and Commences its Clinical Program

Boston/Saratoga Springs, NY; June 14, 2023

Auxilius Pharma has consolidated its financing for developing its lead asset, AUX-001, an innovative new medication for treating chronic-stable angina pectoris in the US, a condition affecting 11 million Americans over the age of 20.[1] The company raised late last year USD 1MM in a seed financing round led EU based by venture capital fund CofounderZone.

“We are extremely happy that already at this early stage, institutional investors have already taken notice of our leadership position in the R&D of new compounds for this common and disabling cardiovascular condition. Later this year, we are planning to start discussions related to further financing for our pipeline development,” says the CEO, Jed Litwiniuk. Litwiniuk, a mid-career executive who has previously headed clinical operations and worked for several financial institutions in the healthcare space, clearly sees the commercial opportunity for Auxilius’ product in development.

Auxilius Pharma, a venture set up in 2019 by founders Uwe Tigör, MD, and Jed Liwiniuk, MHA, after its two founders met during a master’s program at the Mailman School of Public Health at Columbia University. The lead product the company is developing focuses on an area of particularly high unmet clinical need – the treatment of chronic stable angina pectoris (CSAP). A recent enormous study (CLARIFY) has demonstrated that over 1/3 of patients still have angina symptoms five years after diagnosis.[2] The symptomatic treatment of this common cardiovascular condition, most known for its typical exercise-induced chest pain in patients with underlying coronary artery disease, the most common cardiovascular disease in the US, has seen very little development in medications to address the chest pain symptoms that so many patients suffer from. In fact, the approval of Ranexa (ranolazine, Gilead) represents the last anti-anginal agent approved in the US as far back as 2006, more than 15 years ago.[3]

“Treatment of symptomatic angina has not lacked innovation,” says Chief Medical Officer Uwe Tigör, “but it appears we have put our money – and our faith – at least partially on the wrong approach.” That approach is elective invasive revascularization, mainly coronary artery stent placement or PCI and, to a lesser degree, coronary artery bypass grafting (CABG) in an attempt to profit from the tremendous innovations that occurred in this area over the past 25 years. Those procedures pose a significant economic cost to the system, with an average cost of elective PCI[4] and CABG amounting to USD 15,000 and USD 150,000[5], respectively.

Yet two large outcomes trials, COURAGE (2007; a total of 2,277 CSAP patients)[6] and, more recently, ISCHEMIA (2020; a total of 5,177 CSAP patients)[7], further highlighted that proactive, elective revascularization (either by stenting or CABG) has no mortality or morbidity benefits for patients with stable angina but instead leads to excess mortality. Repeating the findings first demonstrated in the COURAGE trial in 2007, ISCHEMIA also demonstrated that angina symptomatology remains largely unchanged in most patients and that optimized medical therapy of chronic stable angina is here to stay as a standard of care.

But current medications used for treating angina in the US do show their age. Says Tigör: “It currently takes most angina patients an average of 2.5 medications to control angina symptoms resulting in a high pill burden - and many still have remaining symptoms. Clearly, this is less than optimal.”

With all this in mind, Auxilius chose to improve further and develop AUX-001, an angina medication in clinical use for over two decades in Europe, and to bring it to the US under the 505(b)2 pathway. AUX-001 features a dual mechanism of action and is, thus far, the only stable angina medication that has successfully demonstrated in an outcomes trial that it not only treats the symptoms of angina but also reduces the risks of the underlying conditions, coronary artery disease, and particularly frequency of hospital visits. This is a crucial benefit, given that angina patients’ utilization of hospital services is three times as high as that of CAD patients without angina.

Since the current form of the medication suffers from a few drawbacks in clinical use, namely its twice-daily dosing and short-lived peak plasma concentration, Auxilius has developed an innovative new once-daily version with a stable, sustained drug release. AUX-001 is expected to be granted a 5-year New Chemical Entity (NCE) market exclusivity in the US, where the reference product has never been approved.

Details of this progress were presented to the cardiorenal division of the FDA in April of 2022 during a pre-IND meeting, which not only confirmed the company’s regulatory strategy to file an NDA under 505(b)2 but also provided detailed guidance of what clinical and non-clinical studies are needed to finalize approval. Auxilius is preparing to conduct a first-in-human exploratory pharmacokinetic study later this year, followed by filing an IND. The main FDA R&D mandate for AUX-001 coming out of the pre-IND meeting is a single phase 3 clinical trial to test AUX-001 in first-line use for the treatment of chronic angina in stable coronary disease patients compared to placebo. Says CMO Tigör “We believe this presents a relatively low bar for success given the exceptional history of our compound in its historical form for use in chronic angina in Europe.”.

About AUX-001

AUX-001, a potent, dual mechanism of action, once-daily anti-anginal, is the lead R&D compound in Auxilius Pharma’s cardiovascular drug development pipeline. The product features anti-anginal efficacy on par with currently approved anti-anginal medications such as beta-blockers, calcium channel blockers, or long-acting nitrates but also features cardioprotective effects. In its presently available form, it also affects the underlying condition, coronary artery disease, leading to better overall disease outcomes, including reductions in hospitalizations for chronic stable angina patients.

About Auxilius Pharma

Auxilius Pharma is a privately held pharmaceutical company that commenced operations in 2019. Auxilius operates in the area of value-added medicines and brings innovation to areas of high unmet need for patients with diseases such as chronic-stable angina pectoris that aim to have a positive impact on public health. Auxilius Pharma’s R&D Strategy is driven by the needs of patients for affordable medications to manage their chronic conditions in the US.