Revalesio has announced data from a post-hoc analysis of its completed Phase 2 RESCUE clinical trial showing that ischaemic stroke patients treated with 1mL/kg/h of RNS60 plus standard-of-care endovascular therapy (EVT) within 12 hours of stroke onset had a larger numerical benefit than the overall group treated within 24 hours.
Of note, the company claims, patients from this subgroup—approximately 75% of the trial participants—experienced a reduction in infarct volume growth post-EVT by more than 50% (nominal p<0.05) and were discharged from the hospital on average 4.8 days sooner (nominal p=0.022) compared to patients who received EVT and a placebo.
These results were presented yesterday during a poster session at the 11th European Stroke Organisation Conference (ESOC; 21–23 May, Helsinki, Finland).
“These data suggest RNS60 could change the trajectory of stroke recovery,” said Bert van den Bergh, Revalesio’s executive chairman of the board of directors. “By preserving brain tissue and reducing the need for long hospital stays or long-term care, we have the opportunity to fundamentally reshape post-stroke care.”
Highlights of the poster presentation from this post-hoc subgroup of subjects who were randomised within 12 hours of last known well (LKW) and received 1mL/kg/h of RNS60 include:
- A reduction in infarct growth of 50% (p<0.05)
- Patients being discharged from the hospital 4.8 days sooner (p=0.022)
- Some 72% of subjects being independent compared to 37% on placebo, as per dichotomised modified Rankin scale (mRS) 0–2 at day 90 (p=0.13)
- RNS60 being generally safe and well tolerated in the overall intent-to-treat population
“There’s an urgent need for therapies that do more than restore blood flow—these data suggest RNS60 may protect the brain itself,” said Greg Archambeau, president of Revalesio and co-inventor of RNS60. “These results support advancing RNS60 into a pivotal Phase 3 trial, with the goal of delivering a meaningful new standard of care.”
