Israeli biotech Nano24 announced that a Phase 2b trial of nebulized EXO-CD24 exosomes in patients with acute respiratory distress syndrome met its primary endpoint, with 85% of patients who received EXO-CD24 having an SpO2/FiO2 >315 at Day 7 compared to 33% of patients who received an inhaled placebo. The trial enrolled 90 adult patients who received either EXO-CD24 delivered by jet nebulizer, 1010 particles per dose, twice a day over 5 days, or nebulized placebo.
Nano24 reports that the study also demonstrated a reduction in mean time that patients remained in the hospital, from 14.4 days for patients who received placebo to 6.5 days for patients who received EXO-CD24, as well as a 69% reduction in all-cause mortality through 6 months compared to placebo. No serious adverse events were reported, and fewer adverse events overall were reported for EXO-CD24 than for placebo.
The company says that it will advance EXO-CD24 into Phase 3 based on the Phase 2b results and that it is considering development of the product for the treatment of other inflammatory conditions. In addition, it notes that, “ARDS is the first clinical proof of concept for Nano24’s engineered exosome platform, which the company aims to use to build a new generation of precisely engineered, biologically inspired therapeutics for diseases with limited treatment options.”
Read the Nano24 press release
