Can a once-daily formulation help address treatment challenges in chronic stable angina? In the latest PharmaShots CXO Talks, Jed Litwiniuk, MHA, CEO, Auxilius Pharma, and Uwe Tigör, MD, CMO, Auxilius Pharma, discuss AUX001, a modified-release nicorandil formulation designed to simplify treatment and advance value-added cardiovascular medicines.
AUX001: Rethinking Chronic Stable Angina Treatment
Auxilius Pharma’s lead program, AUX001, is a once-daily modified-release formulation of nicorandil. By reducing dosing frequency, the company aims to ease medication adherence challenges for patients managing chronic stable angina.
From Clinical Learnings to the Next Milestone
Following Phase 1A, Auxilius Pharma is optimizing the formulation and preparing for a Phase 1B relative bioavailability study comparing AUX001 with immediate-release nicorandil. The company is also progressing its regulatory strategy following an FDA Type C meeting focused on nonclinical requirements ahead of an IND submission.
Advancing Development Through the 505(b)(2) Pathway
Building on an established molecule, Auxilius Pharma aims to improve drug delivery through the FDA’s 505(b)(2) pathway. Its partnership with France-based Skyepharma supports clinical trial material manufacturing as the program advances.
What Comes Next for Auxilius Pharma?
Beyond AUX001, the conversation explores potential cardiovascular research opportunities, future development milestones, and the company’s approach to strategic partnerships.
What will it take to move AUX001 closer to the next stage of development? Watch the full PharmaShots CXO Talks interview to hear Jed Litwiniuk and Uwe Tigör discuss the science, regulatory strategy, and vision behind Auxilius Pharma’s approach to value-added cardiovascular medicines.
About Jed Litwiniuk, MHA
CEO, Auxilius Pharma
Jed Litwiniuk, MHA, CEO of Auxilius Pharma, is a pharmaceutical and healthcare executive with over 15 years of experience in healthcare investment, corporate finance, and business leadership across Europe and the United States. Before co-founding Auxilius Pharma, he held leadership roles at Lux Med, Enterprise Venture Fund, and PZU, and served as CEO of CM Gamma, an orthopedic and spine surgery clinic. He also co-founded New York-based Picket Pharmaceuticals. Jed earned his Executive Master of Health Administration from Columbia University’s Mailman School of Public Health in 2019 and has since focused on advancing Auxilius Pharma’s mission.
About Uwe Tigör, MD
CMO, Auxilius Pharma
Uwe Tigör, MD, CMO of Auxilius Pharma, is a healthcare and pharmaceutical executive with extensive experience in medical marketing, communications, and product launches. He has held Chief Medical Officer and Medical Director roles at leading healthcare agencies, including IPG, WPP, HAVAS Health, and InventivHealth, and has advised pharmaceutical companies as a consultant. Trained in Europe and the United States, Uwe earned his MD from Humboldt University in Berlin and conducted cardiovascular research, including a research fellowship at Mount Sinai Hospital in New York. He is also an MHA candidate at Columbia University’s Mailman School of Public Health.