Auxilius Pharma

Auxilius Pharma is a pharmaceutical company that commenced operations in 2019, focusing on the development of value-added medicines to address unmet needs in cardiovascular health. The company was founded by Jed Litwiniuk, MHA, who serves as CEO, and Uwe Tigör, MD, who is the Chief Medical Officer. Their paths crossed during a master's program at the Mailman School of Public Health at Columbia University, which led to the creation of the venture. Jed Litwiniuk has a background in heading clinical operations and working for healthcare-focused financial institutions.

The company's business model centers on identifying established medications and enhancing them to create improved treatments, often referred to as value-added medicines. This strategy aims to improve clinical outcomes while managing development risks through a simplified regulatory pathway. The company targets the U.S. market, where it seeks to provide affordable medications for chronic conditions. In late 2022, Auxilius Pharma secured $1 million in a seed financing round led by the venture capital fund CofounderZone to advance its clinical program.

The lead asset in Auxilius Pharma's pipeline is AUX-001, a drug developed for treating chronic-stable angina pectoris, a condition affecting approximately 11 million people in the U.S. AUX-001 is a new once-daily, extended-release version of nicorandil, a medication with a long history of use in Europe. This new formulation provides a dual mechanism of action that not only manages angina symptoms but also has cardioprotective effects by addressing the underlying coronary artery disease. A key benefit of AUX-001 is its potential to simplify treatment regimens for patients, reducing the number of daily medications. The company is pursuing a 505(b)(2) regulatory pathway with the FDA, which allows for a more streamlined development process by referencing data from the previously approved drug. Auxilius plans to initiate a Phase Ib bioequivalence study and has received guidance from the FDA for a single Phase 3 clinical trial.

Keywords: cardiovascular health, value-added medicines, chronic-stable angina pectoris, pharmaceutical development, AUX-001, nicorandil, 505(b)(2) pathway, clinical trials, CofounderZone, Jed Litwiniuk, Uwe Tigör, coronary artery disease, drug formulation, biopharmaceutical, cardiovascular drugs, clinical-stage company, pharmaceutical funding, angina treatment, cardioprotective, drug delivery