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A randomized phase IIb trial of 90 patients with acute respiratory distress syndrome found that more patients receiving inhaled EXO-CD24 were free of respiratory failure at day 7 than those receiving placebo. The study also reported shorter hospital stays and lower death rates in the treatment group, but the findings are preliminary and require confirmation in a larger phase III trial.
An inhaled immune-modulating treatment was associated with faster recovery from acute respiratory distress syndrome (ARDS) in a 90-patient phase IIb trial, according to results presented at the CHEST annual meeting on October 20. By day 7, 85% of patients given EXO-CD24 were free of respiratory failure, compared with 33.3% of those given placebo; the researchers say the findings support further testing, not routine use.
The trial randomly assigned 90 patients with ARDS to receive aerosolized saline or EXO-CD24, an engineered exosome-based treatment. The active-treatment group received 10 billion particles in 1.5 milliliters of saline by nebulizer, twice daily for up to five days. Patients discharged from intensive care before day five could finish treatment at home.
Researchers reported a mean hospital stay of 6.5 days with EXO-CD24, compared with 14.4 days with placebo (P=0.0001). Deaths were lower in the treatment group at both reported checkpoints: 6.7% versus 30% by day 28, and 13.3% versus 43.3% by six months. The six-month comparison had a hazard ratio of 0.28 (95% confidence interval 0.084-0.902; P=0.033). These are trial results; they do not by themselves establish that the drug caused the differences.
The treatment was described as well-tolerated. The report said there were no treatment-related or dose-related serious adverse events in the clinical experience cited: 90 participants in the phase IIb trial and 178 patients from earlier study phases. Participants were monitored for safety through day 28, with a final safety check at six months. The report did not provide a detailed breakdown of all adverse events.
A Possible New ARDS Treatment
ARDS is a severe form of lung injury that can lead to respiratory failure and intensive care. The reported differences in day-seven respiratory status, hospital stay and mortality are clinically relevant signals because the report describes few medication options that directly address the condition. However, results from a 90-patient phase IIb study can be affected by the small sample and need replication before clinicians can know whether the apparent benefits hold in broader patient populations.
If larger studies confirm the findings, an inhaled therapy that acts in the lungs could become an additional approach to managing ARDS. For now, the mortality results are promising but preliminary; they should not be treated as proof of a survival benefit or as evidence that the treatment is available for standard care.
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How EXO-CD24 Targets Inflammation
EXO-CD24 uses exosomes, small membrane-bound vesicles that carry biological material between cells. The developers engineered the vesicles to display CD24, a protein involved in regulating immune responses. The proposed approach is to moderate inflammation associated with tissue damage while preserving the body’s ability to recognize pathogens. That mechanism is the developers’ rationale; the trial results reported here do not independently establish how the treatment works in patients.
According to presenting researcher Shiran Shapira of Nano24 and Tel-Aviv Medical Center, the nebulized treatment takes about five minutes per dose and is intended to reach affected lung tissue directly. The phase IIb study compared it with aerosolized saline and assessed recovery, hospital stay and safety. Shapira characterized the results as proof of concept, rather than definitive evidence of effectiveness.
“If this would pan out, it will be very exciting.”
— Alice Gallo De Moraes, MD, Mayo Clinic pulmonologist and critical care expert, who was not involved in the study
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Questions Before Larger Trials
The findings remain early-stage evidence. The available report does not give enough detail to assess how the 90 participants were distributed across ARDS causes or levels of severity, or whether other differences between groups may have influenced outcomes. It also does not provide a full account of adverse events or all trial methods. The reported mortality differences are notable, but the study is too small to settle how reliably EXO-CD24 changes survival.
It is also unclear when a phase III trial will begin, how many people it will enroll, or what countries and hospitals will take part. The report does not say whether regulators have authorized the treatment for clinical use. The results should not be read as a recommendation for patients to seek or receive EXO-CD24 outside an authorized study.
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A Larger International Trial
Shapira said the team plans to advance EXO-CD24 into a larger international phase III trial. That study will need to test whether the recovery and mortality differences persist in a larger group and provide more detail on safety. The developers also plan to examine other possible uses for the exosome delivery platform, but no additional indications or timelines were specified in the report.
The next key update will be the phase III study’s design, start date and results. Until those data are available, the phase IIb findings remain a signal for further research, not confirmation of a new standard ARDS treatment.
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Key Questions
What is EXO-CD24?
EXO-CD24 is an inhaled experimental treatment made from engineered exosomes that display the immune-modulating protein CD24. It was tested in a phase IIb trial in people with ARDS.
What did the phase IIb trial find?
The researchers reported that 85% of patients receiving EXO-CD24 were free of respiratory failure at day 7, compared with 33.3% receiving placebo. They also reported shorter average hospital stays and lower death rates at day 28 and six months; these results need confirmation in larger trials.
Was EXO-CD24 shown to improve survival?
The trial reported lower mortality in the EXO-CD24 group at the measured time points, including 6.7% versus 30% by day 28. Because this was a small phase IIb study, the result is preliminary and does not establish a survival benefit.
Is EXO-CD24 available as a treatment for ARDS?
The source report describes EXO-CD24 as an experimental therapy and says the researchers plan a phase III trial. It does not report approval or availability for routine clinical use.
What happens next?
The research team plans to test the treatment in a larger international phase III study. Its timing, enrollment and design have not yet been specified in the report.
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