Skyepharma Signs Strategic Agreement with Auxilius Pharma to Manufacture Clinical Trial Material for Phase 1b Study of AUX-001
Auxilius Pharma entrusted us with the manufacturing of their Phase 1b trial drugs for AUX-001, indicated for patients with chronic stable angina, leveraging a modified-release technology for oral solid dosage forms. The study plans to enroll 36 healthy volunteers and is scheduled to begin in the first quarter of 2027.
“Following the successful completion of Phase 1a, our focus is now on preparing AUX-001 for the next stage of clinical development. Our agreement with Skyepharma enables us to supply clinical trial material for the planned Phase 1b study. Under our current development timeline, we aim to conduct the study in the first half of 2027 and then begin preparations for Phase 3, while continuing discussions about a potential strategic partnership in the United States”, said Jed Litwiniuk, CEO of Auxilius Pharma S.A.
Partnership aiming at therapeutic innovation and patient comfort
AUX-001 is being developed within the Value Added Medicines (VAM) model. The purpose of this model is to enhance the value of well-established therapies by implementing formulation improvements. In this case, Skyepharma will apply the modified-release oral technology to nicorandil, a marketed vasodilator drug used to treat angina (chest pain that results from episodes of transient myocardial ischemia). Thanks to the partnership between Auxilius Pharma and Skyepharma, patients with angina could benefit from simplified treatment with a reduced dosing frequency, from twice daily to once daily. The patient comfort from daily treatment being significantly improved.
In selecting its manufacturing partner, Auxilius Pharma considered Skyepharma’s extensive experience in developing and manufacturing modified-release medicines, as well as the proposed commercial terms and timelines, which were tailored to the requirements of the planned Phase 1b study.
Sébastien Mas, CEO of Skyepharma
Strategic Collaboration Built on Trust
“We are proud to support Auxilius Pharma as AUX-001 advances to this crucial next stage of clinical development. Our mutual knowledge and trust make this agreement a logical continuation of our partnership. Skyepharma’s expertise in modified-release oral dosage forms allows us to contribute significantly to this promising program, ensuring the highest quality clinical trial material for the Phase 1b study,” said Sébastien Mas, CEO of Skyepharma.
Context and next steps
The previously completed Phase 1a study of AUX-001 evaluated safety, tolerability, and pharmacokinetics, supporting the continuation of development into Phase 1b. Following the 505(b)(2) regulatory pathway in the United States, Auxilius Pharma can bypass a conventional Phase 2 study by relying on existing data for nicorandil, as a well-established active pharmaceutical ingredient. This development strategy will allow Auxilius Pharma to proceed to a single Phase 3 study following a successful Phase 1b study.
This agreement demonstrates Skyepharma’s ability to support pharmaceutical companies in the development and manufacturing of high-value innovative medicines, based on our extensive experience in controlled-release technologies and innovative programs.