Revalesio has reported that in this first in man asthma study, RNS60 demonstrated therapeutic benefit and proved safe at all dose levels. In a multi-dose stage of the phase I study, RNS60 significantly improved peak flows and quality of life scores in patients diagnosed with stable, mild to moderate asthma. These findings demonstrate that RNS60, a novel product containing charge-stabilized nanostructures (CSN), is safe and has therapeutic benefit in human subjects suffering from asthma.
These data suggest CSN solutions provide an opportunity for the development of a new generation of low-risk therapeutics for inflammatory pulmonary diseases. The therapeutic activity seen in Revalesio’s RNS60 is a promising alternative to steroid treatments currently used to control asthma exacerbations.
Revalesio has initiated a further clinical investigation of RNS60 in asthma in combination with the inhaled steroid budesonide. The study will evaluate RNS60 in combination with high and low dose budesonide over a 28 day period to evaluate the effect of the paired therapy on FEV1 scores and other respiratory parameters.