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News|Articles|October 20, 2026

Nano24's Inhaled EXO-CD24 Cuts ARDS Mortality in Phase 2b Trial

Key Takeaways

  • Inhaled EXO-CD24 met its primary end point in a 90-patient phase 2b trial in ARDS.
  • At day 7, 85% of EXO-CD24 patients were free of respiratory failure vs 33.3% with placebo.
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Inhaled EXO-CD24 kept 85% of patients with ARDS free of respiratory failure at day 7 vs 33.3% with placebo in a 90-patient phase 2b trial.

Nano24, a clinical-stage company based in Tel Aviv, Israel, announced on October 20, 2026, that inhaled EXO-CD24, its investigational engineered exosome therapy, met the primary end point of a randomized, double-blind, placebo-controlled phase 2b trial in patients with acute respiratory distress syndrome (ARDS).1 The data were presented in a late-breaking abstract session at the CHEST Annual Meeting 2026 in Phoenix, Arizona, by Shiran Shapira, PhD, cofounder and chief scientific and technology officer of Nano24.1

Key facts

  • Drug: EXO-CD24 (Nano24)
  • Class: Inhaled engineered exosome therapy carrying CD24
  • Indication studied: ARDS (any etiology and stage)
  • Trial: NCT05947747; phase 2b, randomized, double-blind, placebo-controlled
  • Primary endpoint met: 85% free of respiratory failure at day 7 vs 33.3% with placebo
  • Mortality: 72% lower 28-day risk of death
  • Hospital stay: 6.5 days vs 14.4 days
  • Safety: No treatment-related serious adverse events
  • Next step: Larger international phase 3 trial planned
  • Current approval: None

"ARDS remains a serious clinical challenge, and patients need additional treatment options," said Matthew Baldwin, MD, a pulmonary and critical care physician-scientist and associate professor of medicine at Columbia University, in the release.1 "The findings on the proportion of patients free of respiratory failure at Day 7 and on all-cause mortality are encouraging in this deadly condition." Based on the results, the company plans to advance EXO-CD24 into a larger, international phase 3 trial.

How was the phase 2b trial designed, and what did it show?

The trial (NCT05947747)2 enrolled 90 patients with ARDS of any etiology and stage, randomized 2:1 to inhaled EXO-CD24 (n = 60) or placebo (n = 30). EXO-CD24 was administered at 1010 particles per dose twice daily for 5 days. Patients were followed through day 28, with longer-term follow-up at 6 months.1

At day 7, 85% of patients in the EXO-CD24 arm were free of respiratory failure, defined as an oxygen saturation to fraction of inspired oxygen ratio greater than 315, compared with 33.3% in the placebo arm (p<.0001). In an adjusted Cox model, EXO-CD24 was associated with a 72% reduction in the risk of death at 28 days (hazard ratio, 0.28; 95% confidence interval, 0.084-0.902; p=.033).1

The benefit persisted through 6 months, with all-cause mortality of 13.3% in the EXO-CD24 arm vs 43.3% in the placebo arm (p=.003), a 69% relative reduction. Mean hospital stay through day 28 was 6.5 days with EXO-CD24 vs 14.4 days with placebo (p=.0001). EXO-CD24 was well tolerated, with no treatment-related serious adverse events and fewer serious and nonserious adverse events than placebo.1

How does EXO-CD24 work?

EXO-CD24 combines engineered exosomes with the immunomodulatory protein CD24. It is designed to selectively control damage-driven inflammation while preserving the immune system's ability to recognize and eliminate pathogens, delivering its activity directly to the lungs. The therapy has been administered to more than 260 patients in clinical trials and on a compassionate-use basis.1

In an earlier randomized, single-blind, dose-finding trial of 91 patients with mild to moderate COVID-19–related ARDS in Athens, Greece, no adverse events or serious adverse events were judged related to EXO-CD24.3 Nano24 is also evaluating EXO-CD24 in additional inflammatory conditions.1

Why does ARDS need new treatments?

ARDS is marked by severe lung inflammation and impaired oxygenation that can progress to respiratory and multiorgan failure, and it can be triggered by more than 80 causes, including infection, trauma, and acute pancreatitis.1 In the international LUNG SAFE study, hospital mortality was 34.9% for mild, 40.3% for moderate, and 46.1% for severe ARDS.4

What are the limitations?

The results were presented at a medical meeting and have not been published in a peer-reviewed journal. The trial enrolled 90 patients, and the company noted that its size limits conclusions about uncommon risks.1 The mortality finding comes from an adjusted model with a wide confidence interval. The earlier trial was single-blind and lacked a placebo group.3 Nano24 did not disclose a start date or design details for the planned phase 3 trial.

References

  1. Nano24. Nano24 reports positive phase 2b results for inhaled EXO-CD24 in acute respiratory distress syndrome (ARDS) at the CHEST Annual Meeting 2026. Press release. Published October 20, 2026. Accessed October 20, 2026. https://www.businesswire.com/news/home/20261020667516/en/Nano24-Reports-Positive-Phase-2b-Results-for-Inhaled-EXO-CD24-in-Acute-Respiratory-Distress-Syndrome-ARDS-at-the-CHEST-Annual-Meeting-2026
  2. Safety and efficacy of EXO-CD24 in preventing clinical deterioration in patients with mild-moderate ARDS. ClinicalTrials.gov; NCT05947747. Updated July 27, 2023. Accessed October 20, 2026. https://clinicaltrials.gov/study/NCT05947747
  3. Grigoropoulos I, Tsioulos G, Kastrissianakis A, et al. The safety and potential efficacy of exosomes overexpressing CD24 (EXO-CD24) in mild-moderate COVID-19 related ARDS. Respir Res. 2024;25(1):151. doi:10.1186/s12931-024-02759-5
  4. Bellani G, Laffey JG, Pham T, et al. Epidemiology, patterns of care, and mortality for patients with acute respiratory distress syndrome in intensive care units in 50 countries. JAMA. 2016;315(8):788-800. doi:10.1001/jama.2016.0291

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