MENU

Nano24 EXO-CD24: Phase 2b ARDS mortality and efficacy results

BioPharm International USA
Overview
Inhaled EXO-CD24 significantly reduced 28-day mortality risk by 72% and shortened hospital stays in a phase 2b trial for acute respiratory distress syndrome (ARDS). The therapy achieved its primary endpoint, with 85% of patients free of respiratory failure at day 7 compared to 33.3% for placebo. These results support the transition to a larger international phase 3 trial for this engineered exosome therapy.
In Depth

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

Get our weekly technology intelligence — free

Receive an infographic that lets you judge at a glance whether each field’s analysis report is worth reading.

Subscribe Free — Weekly Tech Intelligence

By subscribing, you’ll receive Troy-Technical’s weekly technology intelligence newsletter.

  • Your email and selected fields are used only to deliver the newsletter.
  • We never share your information with third parties.
  • You can unsubscribe anytime via the link in each email.

See our Privacy Policy for details.

Takes about a minute · Unsubscribe anytime

Published by Troy-Technical, an independent site run by one engineer with a career in materials development.
About the author / Contact info@troy-technical.jp
Let's share this post !

Author of this article

TOC