Abstract Details

Title RESCUE: A Proof-of-Concept Trial with Adjunct RNS60 Treatment Shows Safety, Reduced Infarct Growth, and Numerical Improvement in all Prespecified Efficacy Endpoints in Participants with Acute Ischemic Stroke

Topic Cerebrovascular Disease and Interventional Neurology

Presentation(s) S25 - Emerging Stroke Therapies and Risk Stratification (2:12 PM-2:24 PM)

Poster/Presentation
Number 007

Background RNS60 is an experimental cytoprotective drug that showed significant therapeutic promise in rodent and primate models of ischemic stroke. RESCUE aimed to test adjunctive treatment with RNS60 in subjects with large vessel occlusion and acute ischemic stroke undergoing endovascular thrombectomy.

Objective Testing RNS60 as a new adjunctive cytoprotective therapy for acute ischemic stroke.

Design/Methods The multicenter, placebo-controlled, double-blind, Phase 2 study enrolled 82 participants, randomized for age, NIHSS, and ASPECTS to a 48-hour infusion with RNS60 0.5 mL/kg/h, RNS60 1 mL/kg/h, or placebo 1 mL/kg/h (1:1:1). Participants were followed for 90 days with safety as primary objective. The primary efficacy endpoints included dichotomized day-90 mRS, infarct volume at 48 hours, BI, EQ-5D-5L on day-90, and NIHSS at multiple time points.

Results The study met its primary endpoint of safety and mortality, with similar rates of SAEs and lower numbers of deaths in the RNS60 groups compared to placebo. The RNS60 1 mL/kg/h group performed numerically better than placebo in all prespecified endpoints and had a 50% reduced infarct growth at 48 hours post-EVT (p<.05). On Day 90, RNS60 1 mL/kg/h demonstrated i) a 16% higher number of subjects with mRS 0-2 (OR 3.7, p=.36), ii) a higher number of subjects with BI ≥ 95 (71% on RNS60 1 mL/kg/h vs. 43% on placebo; OR 5.8, p=.13), iii) improved EQ-5D-5L index score (0.74 ± 0.13 on RNS60 1 mL/kg/h vs. 0.58 ± 0.13 on placebo; p=.09) and iv) improved NIHSS score at each pre-specified time point.

Conclusions Adjunct treatment with RNS60 was generally safe and well tolerated, significantly reduced infarct growth, and demonstrated numerical improvement in all efficacy outcomes compared to placebo. Although not all differences are statistically significant in the context of limited power, these differences and odds ratios reflect a large, clinically meaningful difference. A Phase 3 study is in development.

Authors/Disclosures
Supurna Ghosh, PhD (Revalesio) PRESENTER	Dr. Ghosh has received personal compensation for serving as an employee of Revalesio Corporation.
Jordan S. Dubow, MD	Dr. Dubow has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Revalesio .
Jocelyn Sutherland (Revalesio)	Jocelyn Sutherland has received personal compensation for serving as an employee of Revalesio.
Grayson Baird	No disclosure on file
Wendy Smith (Rhode Island Hospital)	Wendy Smith has nothing to disclose.
David Chiu, MD (Houston Methodist Hospital)	Dr. Chiu has nothing to disclose.
Wayne M. Clark, MD (Oregon Health Sciences Univ)	Dr. Clark has nothing to disclose.
Christopher G. Favilla, MD (University of Pennsylvania)	The institution of Dr. Favilla has received research support from National Institutes of Health. The institution of Dr. Favilla has received research support from American Heart Association. The institution of Dr. Favilla has received research support from OpenWater, Inc..
Sameer Ansari	Mr. Ansari has nothing to disclose.
Andreas Kalmes, PhD (Revalesio)	Dr. Kalmes has received personal compensation for serving as an employee of Revalesio.
Jarrad Mock (Revalesio Corporation)	Jarrad Mock has received personal compensation for serving as an employee of Revalesio.
Douglas Cook	Douglas Cook has nothing to disclose.
Tracy Madsen	No disclosure on file
Tracy Madsen	No disclosure on file
Mahesh Jayaraman	No disclosure on file
Krisztina Moldovan	Krisztina Moldovan has nothing to disclose.
Radmehr Torabi (Rhode Island Hospital)	Radmehr Torabi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Silk Road Medical.
David S. Liebeskind, MD, FAAN (Neurovascular Imaging Research Core at UCLA)	Dr. Liebeskind has received research support from Cerenovus. Dr. Liebeskind has received research support from Genentech . Dr. Liebeskind has received research support from Medtronic. Dr. Liebeskind has received research support from Stryker.
Ryan A McTaggart	No disclosure on file

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