Policy & Regulation
Revalesio reveals topline data from RNS60 Phase two RESCUE clinical trial at ISC 2024
8 February 2024 -

Revalesio, a US-based clinical-stage pharmaceutical company, announced on Wednesday that it has revealed topline data from the completed Phase two RESCUE clinical trial of RNS60 (NCT04693715) in acute ischemic stroke (AIS) patients during an oral presentation at the Late-Breaking Science session of the International Stroke Conference (ISC) 2024.

RNS60, Revalesio's lead product candidate, consists of a stable formulation of saline saturated with oxygen through a proprietary process. The company says that RNS60 initiates a cascade of biological effects that show significant benefits in preclinical models of acute and chronic neurological disorders, while showcasing a strong safety profile in the 400+ patients who have been administered RNS60 in previous trials.

The company assessed the safety and signs of efficacy of RNS60 in RESCUE, a double-blinded, placebo-controlled, randomised proof-of-concept trial. The trial had two primary endpoints: safety and mortality. The product met its primary endpoints of safety and mortality, with similar rates of SAEs and numerically lower rates of mortality. Its high dose decreased infarct growth by 50% (nominal p