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Auxilius Pharma S.A., a biotechnology company developing value-added medicines (VAMs) in cardiology, has signed an agreement with Skyepharma to manufacture Clinical Trial Material (CTM) for the planned Phase 1b study of AUX-001. The study is expected to enroll 36 volunteers and is scheduled to begin in the first quarter of 2027.

The agreement marks another important step in preparations for the next stage of clinical development of Auxilius Pharma's lead program, AUX-001. The asset is indicated for patients with chronic stable angina.

Skyepharma is a French-based CDMO specializing in the development and manufacturing of modified-release oral solid dosage forms. Under the agreement, Skyepharma will manufacture the clinical trial material required for the Phase 1b study of AUX-001.

The decision to partner with Skyepharma also builds on a relationship that has developed between the two teams over several years. 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.

– 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.

– We are pleased to support Auxilius Pharma as AUX-001 advances to its next stage of development. Our teams have known each other for several years, making this agreement a natural next step in our relationship. Skyepharma's extensive experience with modified-release oral dosage forms enables us to apply our expertise to the exciting AUX-001 program, which is now entering another important stage of clinical development, said Sébastien Mas, CEO of Skyepharma.

AUX-001 is being developed within the Value Added Medicines (VAM) model, which aims to enhance the clinical value of well-established therapies through approaches such as formulation improvements or changes to dosing regimens. The program uses nicorandil in a proprietary modified-release oral formulation designed to reduce dosing frequency from twice daily to once daily, thereby simplifying treatment and improving convenience for patients with chronic stable angina.

The previously completed Phase 1a study evaluated the safety, tolerability, and pharmacokinetics of AUX-001. The results supported continuation of the clinical development program and enabled the company to proceed with preparations for Phase 1b.

AUX-001 is being developed primarily with the U.S. market in mind, as nicorandil has never been approved in the U.S. The project follows the 505(b)(2) regulatory pathway, which allows developers to rely in part on existing data for a well-established active pharmaceutical ingredient, often substantially reducing the scope of development compared with a completely new molecular entity. Under the current development strategy, this pathway will allow Auxilius Pharma to bypass a conventional Phase 2 study and, following Phase 1b, proceed to a single Phase 3 study.

Another key objective for Auxilius Pharma is to position AUX-001 for a strategic partnership, targeting the United States and Canada as the primary markets.

– The United States is the key market for the further development of AUX-001. The regulatory pathway we have selected allows us to leverage the wealth of existing clinical data on nicorandil and focus on the next stages of clinical development. Our goal is to build a strong foundation for Phase 3 development and, ultimately, to bring AUX-001 to the U.S. market together with a strategic partner – added Jed Litwiniuk, CEO of Auxilius Pharma S.A.

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About Auxilius Pharma S.A.

Auxilius Pharma is a privately held pharmaceutical company that commenced operations in 2019. Auxilius operates in the Value Added Medicines space and brings innovation to areas of high unmet need for patients with diseases such as chronic stable angina pectoris, aiming to positively impact public health. Auxilius Pharma's R&D Strategy is driven by patients' need for affordable medications to manage their chronic conditions in the US and other major markets. The Company has initiated a capital tie-up process with NanoGroup S.A., a company listed on the Warsaw Stock Exchange, focused on innovative normothermic transplant transportation and preservation solutions. The capital operation is designed to strengthen Auxilius' financial position and accelerate pipeline development. Auxilius will continue to operate as an independent company.