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Breathing Hope For ARDS Patients

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About Us

Who We Are

4Living Biotech (4LB) is a clinical-stage, asset-centric biotechnology company, incorporated in mid-2020 as a subsidiary of 4P-Pharma, a Start-up Studio based in France. The company is focused on addressing Acute Respiratory Distress Syndrome (ARDS) through the development of a first-in-class precision medicine program.

4LB operates within a translational research framework originally developed by 4P-Pharma, leveraging collaborations with leading Key Opinion Leaders and clinical partners, including the University Hospitals of Bordeaux, Tours, and Lille.

 

Our Mission

4Living Biotech is committed to addressing the critical unmet medical need of Acute Respiratory Distress Syndrome (ARDS) — a life-threatening condition affecting over 3 million patients annually worldwide, with mortality rates reaching 46–60% in severe cases and no approved pharmacological therapy to date.

Through clinical development, 4LB is advancing an integrated precision medicine program combining 4P021, a first-in-class CXCR4-targeted therapy, with CX-DiagPlex, a rapid biomarker–based diagnostic test enabling patient stratification. Together, they aim to transform ARDS management by significantly reducing morbidity and mortality in a biologically defined patient population.

Our Milestones

  • 2016
  • 2020
  • 2021-2022
  • 2022
  • 2023
  • 2024
  • 2025

IP Foundation — Patent family WO2016/120369 filed by Université de Bordeaux, CHU Bordeaux & INSERM covering CXCR4 inhibitors in inflammatory lung diseases (granted in EU, US, China, Japan, Australia, Canada, Israel) — 4LB will later hold exclusive sublicence

Foundation of 4Living Biotech — Incorporated as a clinical-stage subsidiary of 4P-Pharma (Start-up Studio, France), with a dedicated focus on ARDS. 4LB acquires exclusive sublicence on WO2016/120369

Preclinical validation – Robust efficacy demonstrated across 3 relevant murine models of ARDS

  • LEONARDO Study — Regulatory Foundations — Clinical Trial Authorizations (CTAs) obtained in 5 European countries (France, Spain, Netherlands, Bulgaria, Ukraine)
  • EMA Scientific Advice — Favourable opinion on 4P021 clinical development plan
  • FDA Positive Regulatory Feedback — Positive feedback on LEONARDO study design
  • IQVIA Market Analysis — Independent market analysis commissioned, confirming ~564,000 ARDS cases in EU5 and ~697,000 in the US
  • Program Expansion — Program broadened from COVID-19-associated ARDS to pan-aetiology ARDS, retaining all regulatory assets while expanding the therapeutic opportunity
  •  In Silico Validation — Large-scale retrospective analysis using US electronic medical records; collaboration with QuantHealth AI demonstrating
  •  CHOPIN Clinical Study Initiated — Multicentre observational study launched across CHU Bordeaux, Tours and Lille; preliminary results already indicating association between CXCR4 expression and disease severity
  • EU Orphan Drug Designation — ODD granted (EU/3/24/2899) for the treatment of ARDS — up to 10 years of market exclusivity post-approval
  • TRL Milestones Achieved – CX-DiagPlex reaches TRL 5; 4P021 therapeutic component reaches TRL 6
  • New ARDS Patent Filed – WO2025/202445 (Oct. 2025), co-owned by CHU Bordeaux, Université de Bordeaux, INSERM & 4LB – covering CXCR4 inhibitors in severe ARDS patients with elevated NETosis biomarkers, protection until 2044

Scientific Foundations

  • Understanding ARDS

    Growing evidence indicates that, a shared immune mechanism drives tissue damage across all ARDS etiologies: the pathological accumulation of CXCR4⁺ neutrophils, particularly prone to NETosis, a process that amplifies inflammation and destroys lung tissue. Elevated NETosis plasma markers are directly associated with mortality in ARDS, defining a biologically distinct patient subgroup across diverse etiologies. whose immune signature is independent of the underlying cause.

  • Biomarkers for ARDS

    Our approach focuses on circulating NETosis biomarkers, as a proxy for CXCR4⁺ neutrophil accumulation in the lungs

  • Our Innovative Scientific Approach

    This stratification is being validated through the CHOPIN study and will be translated into clinical practice through CX-DiagPlex, a rapid point-of-care diagnostic measuring NETosis biomarker at ICU admission. The right treatment, for the right patient, at the right moment time.

Therapeutic Approach

4P021, potential ARDS game-changer

Our Approach

Rather than targeting a specific pathogen or downstream inflammatory mediator, 4P021 acts upstream, blocking the pathological recruitment of CXCR4⁺ neutrophils and their propensity for NETosis before irreversible lung damage occurs, regardless of ARDS aetiology. Paired with a companion diagnostic approach using CX-DiagPlex, this integrated precision medicine strategy ensures the right treatment reaches the right patient, independent of the underlying cause of disease.

Translational Studies

Our translational strategy bridges preclinical findings and clinical development through three converging evidence streams: robust preclinical efficacy across multiple ARDS models, large-scale in silico validation via QuantHealth AI projecting a 17.5% absolute risk reduction in 30-day mortality, and prospective clinical biomarker validation through the CHOPIN study (NCT06254313) — together building a coherent and de-risked path from bench to bedside.

Development of a companion diagnostic strategy

The CHOPIN study directly informs the development of CX-DiagPlex, a rapid point-of-care measuring circulating NETosis biomarker from blood at ICU admission. Designed for seamless integration into critical care workflows, CX-DiagPlex identifies the CXCR4-driven endotype within minutes, without laboratory infrastructure, ensuring no eligible patient is missed at the critical treatment window.

Phase 2 Clinical Trial

These converging evidence streams enable a Phase 2a/2b biomarker-guided clinical trial in a biologically defined ARDS endotype. CX-DiagPlex drives patient selection at ICU admission, ensuring enrolment is restricted to the subpopulation most likely to respond to 4P021 — directly overcoming the stratification failure that has undermined all prior ARDS trials.

Our Drug Candidate

Our multifaceted approach addresses diverse healthcare challenges

Respiratory & infectious diseases
Drug Dev stage
Preclinical
Phase I
CHOPIN trial
Phase II
Phase III
Drug Dev stage

  • CHOPIN trial

    The CHOPIN trial, co-sponsored by CHU BDX and 4Living Biotech , will also help identify and refine meaningfull biomarkers to support the development of a future companion diagnostic approach, which is key to the therapeutic strategy of 4P021. Ultimately, this blood-based rapid test could enable the identification of eligible patients within 5 to 10 minutes, helping ensure that those most likely to benefit are selected.

    The combination of 4P021’s immunomodulatory action with a biomarker-driven patient selection strategy could significantly improve ARDS management.

People

A seasoned management team combining entrepreneurship and medical science

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4Living Biotech at SRLF 2025

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