Key Findings
In a randomized, double-blind, placebo-controlled phase 2b trial (NCT05947747) involving 90 patients, inhaled EXO-CD24 met its primary endpoint. At day 7, 85% of patients treated with EXO-CD24 were free of respiratory failure, defined as an oxygen saturation to fraction of inspired oxygen ratio greater than 315, compared to 33.3% in the placebo group (p<.0001). An adjusted Cox model showed a 72% reduction in the 28-day risk of death (hazard ratio 0.28; p=.033). Long-term follow-up at 6 months showed all-cause mortality of 13.3% for the EXO-CD24 arm versus 43.3% for placebo (p=.003), representing a 69% relative reduction.
Technical Details
EXO-CD24 is an engineered exosome therapy carrying the immunomodulatory protein CD24. It is designed to deliver activity directly to the lungs to selectively control damage-driven inflammation while maintaining the immune system’s ability to eliminate pathogens. In the phase 2b trial, patients were randomized 2:1 (n=60 for EXO-CD24; n=30 for placebo). The treatment consisted of 1010 particles per dose administered twice daily for 5 days. Mean hospital stay through day 28 was reduced to 6.5 days with EXO-CD24, compared to 14.4 days with placebo (p=.0001).
Background and Context
ARDS is characterized by severe lung inflammation and impaired oxygenation, triggered by over 80 causes including trauma, infection, and acute pancreatitis. Hospital mortality rates for ARDS vary by severity: 34.9% for mild, 40.3% for moderate, and 46.1% for severe cases. Nano24 has previously administered EXO-CD24 to over 260 patients, including a single-blind dose-finding trial of 91 patients with mild to moderate COVID-19-related ARDS in Greece, which reported no treatment-related serious adverse events.
Significance and Outlook
The phase 2b trial reported no treatment-related serious adverse events and fewer overall adverse events than the placebo group. While the results are encouraging, they were presented at the CHEST Annual Meeting 2026 and have not yet been published in a peer-reviewed journal. Nano24 plans to advance EXO-CD24 into a larger international phase 3 trial and is evaluating the therapy for other inflammatory conditions.
Source: https://www.biopharminternational.com/view/nano24-inhaled-exo-cd24-ards-phase-2b-mortality
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