Policy & Regulation
Revalesio to reveal RNS60 Phase 3 trial results at SNIS Annual Meeting
15 July 2025 -

Revalesio, a US-based clinical-stage pharmaceutical company developing treatments for acute and chronic neurological disorders, announced on Monday that two abstracts featuring its investigational treatment RNS60 in acute ischemic stroke (AIS) have been accepted for oral presentation at the Society of NeuroInterventional Surgery's (SNIS) 22nd Annual Meeting, taking place in Nashville, TN, 14-18 July 2025.

The presentations will highlight the objectives and design of the company's upcoming Phase 3 RESTORE clinical trial in AIS, as well as a new post hoc analysis from its prior Phase 2 RESCUE study of RNS60 in AIS. Both presentations are scheduled for Thursday, 17 July.

RNS60 is a novel, investigational therapy being evaluated as an adjunct treatment for patients with AIS undergoing endovascular thrombectomy. The therapy targets infarct growth reduction during the acute injury phase, thereby aiming to increase the number of stroke survivors who retain their functional independence.

In RESCUE, a multi-centre, double-blinded, placebo-controlled, randomised Phase 2 clinical trial, Revalesio evaluated the safety and initial efficacy of RNS60. Eighty-two participants with AIS eligible for endovascular thrombectomy (EVT) were enrolled and received intravenous RNS60 0.5 mL/kg/h (low dose), RNS60 1.0 mL/kg/h (high dose), or placebo starting before completion of the EVT and continuing for 48 hours.

The trial had two primary endpoints: safety and mortality. Secondary endpoints for the study evaluated disability based on the well-established modified Rankin Scale (mRS), change in the size of the stroke as measured by MRI at 48 hours, and additional endpoints including Barthel Index, NIHSS, and EQ-5D-5L.

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