ABIONYX Pharma’s sepsis project gains recognition under France 2030 plan

FRANCE – ABIONYX Pharma, a biotech company pioneering therapies based on the world’s only natural recombinant apoA-I, has achieved a major milestone in its clinical development for sepsis.

The company’s CER-001 Sepsis project has been selected under the “i-Démo” call for projects as part of the France 2030 plan, which is managed by Bpifrance on behalf of the French government.

This selection follows a six-month evaluation by a panel of experts who assessed the scientific, technological, and clinical quality of the project.

With over 20 years of expertise, ABIONYX Pharma is the world leader in recombinant apoA-I research and development.

The company has already demonstrated the safety, effectiveness, and therapeutic potential of this protein in LCAT deficiency, a rare metabolic disorder.

Now, ABIONYX is expanding its focus to severe inflammatory diseases, including cytokine storms, ophthalmology, and neurology.

A new approach to sepsis treatment

Sepsis, also referred to as generalized infection or septic shock in severe cases, is a life-threatening condition that occurs when the body’s immune system overreacts to an infection, leading to multi-organ failure.

It affects over 49 million people worldwide each year and is responsible for nearly 11 million deaths, making it one of the leading causes of mortality globally.

Despite advances in critical care, there is currently no specific targeted treatment for sepsis, with existing therapies limited to antibiotics, supportive care, and symptom management.

ABIONYX Pharma aims to change this with its innovative recombinant apoA-I therapy (CER-001). This naturally occurring protein has powerful anti-inflammatory, antioxidant, and immune-modulating properties.

By neutralizing endotoxins, reducing cytokine storms, and protecting vital organs, CER-001 offers a new therapeutic approach that could significantly lower sepsis-related mortality and reduce long-term complications.

A dual strategy for sepsis research

The CER-001 Sepsis project operates on two strategic fronts:

1. An Integrated Biomedicine Approach – ABIONYX Pharma has secured proprietary patents until 2042, ensuring a strong foundation for its bioproduction and biotherapy approach.
2. An Innovative Clinical Strategy – In cases of severe inflammation, circulating apoA-I levels drop. By supplementing recombinant human apoA-I, CER-001 has the potential to treat all patients, including those who are immunocompromised.

Following positive Phase 2a clinical results, the company is now advancing to a Phase 2b/3 study across the United States and Europe.

This study aims to confirm a significant reduction in mortality, paving the way for a breakthrough treatment in sepsis care.