Auxilius Pharma S.A., a biotechnology company set to join the NanoGroup, has signed an agreement with French CDMO Skyepharma for the manufacture of clinical trial material to support the planned Phase 1b study of AUX-001. The study is expected to enrol 36 volunteers and is scheduled to take place in the first half of 2027.

The agreement with Skyepharma marks another important milestone in the clinical development of AUX-001, which Auxilius Pharma is developing for patients with chronic stable angina pectoris.

Auxilius Pharma develops Value Added Medicines (VAM), focusing on the use of established active pharmaceutical ingredients in new formulations or dosing regimens. The company’s flagship project, AUX-001, uses nicorandil in an oral modified-release formulation. The formulation under development is intended to reduce dosing frequency from twice daily to once daily, improving treatment convenience.

Preparations for Phase 1b

Under the agreement, Skyepharma, a French company specialising in the development and manufacture of modified-release oral solid dosage forms, will manufacture clinical trial material (CTM) for the AUX-001 Phase 1b study.

The agreement is one of the key components of preparations for the next stage of the clinical programme. Auxilius Pharma has previously completed the Phase 1a study, which assessed the safety, tolerability and pharmacokinetics of AUX-001. The results enabled the programme to advance and preparations for Phase 1b to begin.

“Following the successful completion of Phase 1a, we are focusing on preparing for the next stage in the development of AUX-001. Signing the agreement with Skyepharma enables us to deliver one of the key prerequisites for conducting Phase 1b: the manufacture of clinical trial material. According to our current timeline, we aim to conduct the study in the first half of 2027, followed by preparations for Phase 3 and further discussions regarding strategic partnering in the United States,” said Jędrzej Litwiniuk, President of the Management Board of Auxilius Pharma S.A.

AUX-001 is being developed primarily for the U.S. market under the FDA’s 505(b)(2) regulatory pathway, which allows the use of existing data on a well-characterised active pharmaceutical ingredient such as nicorandil. This pathway may enable the programme to proceed directly from Phase 1b to preparations for a Phase 3 study, bypassing Phase 2 entirely. This could significantly improve the project’s prospects for success, reduce development costs and shorten time to market.

Auxilius Pharma in the Process of Joining NanoGroup

The development of Auxilius Pharma and the AUX-001 project is an important element of the planned integration of the company into the NanoGroup.

In June 2026, NanoGroup signed an investment agreement with Auxilius Pharma shareholders providing for a share exchange, with the aim of enabling NanoGroup to acquire up to 100% of Auxilius Pharma’s shares.

On 25 August 2026, NanoGroup shareholders collectively holding 35.85% of the voting rights entered into an agreement ahead of the Extraordinary General Meeting (EGM) of NanoGroup. This agreement represents another significant step in the planned integration of Auxilius Pharma into the NanoGroup.

However, the final decision on whether to proceed with the transaction rests with NanoGroup’s shareholders. It is scheduled to be taken at the Extraordinary General Meeting of NanoGroup on 26 August 2026. The agenda includes, among other items, a vote on the issuance of Series O shares at an issue price of PLN 4.20 per share, in accordance with the terms of the investment agreement.

Subject to obtaining the required approvals, the transaction will pave the way for Auxilius Pharma to join the NanoGroup and for the further joint development of biotechnology projects.

“The United States is a key market for the further development of AUX-001. The regulatory pathway we have selected is well suited to the nature of our project and allows us to focus on its subsequent clinical development milestones. Our goal is to establish a solid foundation both for preparing Phase 3 and for the future launch of AUX-001 in the U.S. market in collaboration with a strategic partner,” added Jędrzej Litwiniuk.

For NanoGroup, the potential integration of Auxilius Pharma would expand the Group’s portfolio with a clinical-stage project in cardiology and create further opportunities to build the value of AUX-001 in the U.S. market.