ABIONYX Secures Up to €33M and Launches Pivotal Phase 2b Trial of CER-001 in Sepsis
核心洞察
ABIONYX Pharma (搜索) has secured financing of up to €33 million, providing financial visibility through the end of 2028 for its priority programs.
The company will initiate a pivotal Phase 2b trial of CER-001 in sepsis (搜索) by the end of 2026, with first results expected in the first half of 2028.
ABIONYX is preparing an EMA marketing authorization application for CER-001 in LCAT deficiency (搜索), targeting submission by early 2028 after two GMP validation batches in 2027.
ABIONYX Pharma (搜索) will launch the largest pivotal clinical trial to date for its lead candidate CER-001 in sepsis (搜索), following a financing round that raised up to €33 million and gives the company financial visibility through the end of 2028. The Toulouse, France- and Fullerton, United States-based biopharmaceutical company disclosed the plans alongside the approval of all resolutions at its Combined General Meeting on June 30, 2026.
Sepsis (搜索), described by the company as the third leading cause of death worldwide, is the primary focus of the company's proprietary apoA-I (搜索)-based technology platform, which is designed to target the immune-inflammatory dysregulation at the core of sepsis and other severe diseases.
Phase 2b Sepsis Trial Timelines
ABIONYX said it intends to initiate a pivotal Phase 2b clinical trial of CER-001 in sepsis (搜索) by the end of 2026, with first results expected in the first half of 2028. The company characterized the study as the largest pivotal trial for CER-001 in the indication and placed clinical execution, data quality, and progressive monetization of its scientific platform at the center of its next value-creation cycle.
LCAT Deficiency Market Access Path
In parallel, ABIONYX is advancing regulatory and manufacturing work toward approval of CER-001 for LCAT deficiency (搜索). The company plans to validate production of two GMP batches in 2027 to support submission of a marketing authorization application to the European Medicines Agency by early 2028.
To support that industrial dossier, ABIONYX established a strategic partnership with TEXCELL (搜索), a division of ABL Diagnostics (搜索), covering viral safety and clearance testing of its biopharmaceutical development. Viral clearance studies are designed to demonstrate that the manufacturing process incorporates steps capable of effectively removing or inactivating potential viral contaminants — a requirement specific to biologic products.
TEXCELL (搜索)'s viral safety studies will confirm the industrial process parameters required for production of the two validation batches requested by regulatory authorities. The studies will be conducted on TEXCELL's viral safety and clearance platforms, which the companies said comply with international regulatory standards and are intended to document the robustness of the manufacturing process against criteria expected for biologics destined for major global markets, particularly the United States.
Cyrille Tupin, Chief Executive Officer of ABIONYX Pharma (搜索), said: "Our partnership with TEXCELL (搜索) represents a significant step forward in the industrialization of CER-001. We have selected an internationally recognized platform with expertise in viral safety and biosafety to support us through a strategic phase of our development. This collaboration strengthens our industrial and regulatory dossier and contributes to preparing the next stages of CER-001's development for the treatment of LCAT deficiency (搜索)."
Chalom Sayada, Chief Executive Officer of TEXCELL (搜索) – ABL Diagnostics (搜索), added: "We are proud to support ABIONYX Pharma (搜索) at this important stage in the development of CER-001. Viral safety and clearance studies are an essential component of biologic drug development. Through the combined expertise of TEXCELL and ABL Diagnostics, we are providing ABIONYX Pharma with an internationally recognized scientific platform that meets the highest regulatory standards and is capable of supporting innovative biopharmaceutical companies through the most advanced stages of their development."
Industrialization in France
The TEXCELL (搜索) collaboration forms part of a broader industrial program for CER-001 in France aimed at demonstrating that the manufacturing process is fully controlled, reproducible, documented, and compliant with regulatory requirements applicable to biologic drugs. Production of process validation batches is a pivotal step in that effort, intended to show the process can consistently reproduce a bioproduct meeting predefined quality specifications under controlled conditions.
ABIONYX said the milestone allows it to advance three aspects of industrialization in parallel: the quality and safety of CER-001, preparation of its industrial and regulatory environment, and establishment of the industrial conditions required for future market launch. The company said it is securing industrial autonomy in France while progressively building the expertise required for biomanufacturing of CER-001, and intends to advance clinical development, biomanufacturing, analytical control, quality, and regulatory preparation in a coordinated manner.
Platform Ambitions Beyond Sepsis
ABIONYX said it has spent more than two decades developing knowledge of apoA-I (搜索) and its role in inflammatory and metabolic mechanisms, and that data from its R&D programs now constitute a scientific asset intended to support CER-001's clinical development, strengthen scientific collaborations, and open new development avenues. The company said it will actively pursue collaborations with academic, industrial, and technology partners to accelerate commercialization of the platform, and stated a longer-term ambition to become a leading player in treatments targeting severe inflammatory diseases, rare diseases, and conditions in which apoA-I can play a decisive therapeutic role.
The company's stated priorities for coming quarters include adherence to clinical and GMP production timelines for sepsis (搜索) and LCAT deficiency (搜索), generating clinical data intended to establish CER-001 as a new standard of care in both indications, optimizing the recombinant apoA-I (搜索)-based platform, preparing for subsequent regulatory steps, and maintaining rigorous financial management. ABIONYX is scheduled to report its cash position and an update on second-quarter 2026 activity on August 27, 2026.