Phase 2 RESCUE Data Show RNS60 Reduces Stroke Infarct and Improves Outcomes

Is this enough for your incompetent doctor and hospital to create protocols for their hospital? 

Do you prefer your doctor and hospital incompetence NOT KNOWING? OR NOT DOING?

 Phase 2 RESCUE Data Show RNS60 Reduces Stroke Infarct and Improves Outcomes

Author(s):

Marco Meglio

Conferences|American Academy of Neurology Annual Meeting (AAN)

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Key Takeaways

• RNS60 treatment in AIS patients reduced hospitalization time by 4.8 days and significantly attenuated infarct growth in the high-dose cohort.
• High-dose RNS60 led to better functional outcomes, with more patients discharged home and achieving independence at 90 days.

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High doses of RNS60 led to greater number of patients with modified Rankin scale scores between 0-2, improved EQ-5D-5L index score, and enhanced NIHSS score at each pre-specified time point over placebo.

David S. Liebeskind, MD

Recently presented data from the phase 2 RESCUE trial (NCT04693715), a placebo-controlled study of investigational RNS60 (Revalesio) in patients with acute ischemic stroke (AIS), revealed that the treatment with the agent in addition to standard of care was safe, and led to reductions in hospitalization time and infarct volume growth. Overall, these data further support the development of the anti-inflammatory and cytoprotective treatment in larger phase 3 settings, which are currently in development.^1,2

In this blinded, multicenter trial, 82 patients with AIS were randomly assigned to intravenous (IV) RNS60 0.5 mL/kg/h (low dose), RNS60 1.0 mL/kg/h (high dose), or placebo starting before completion of endovascular therapy (EVT). Presented at the 2025 American Academy of Neurology (AAN) Annual Meeting, held April 5-9, in San Diego, California, results showed that RNS60 treatment with SOC led to a 4.8-day reduction in the average amount of time spent in a hospital relative to those on placebo (P = .022). In addition, those in the high-dose cohort demonstrated a 50% attenuation in infarct growth, which was considered statistically significant (P <.05).

"Revalesio's choice to capture infarct growth post-EVT is a great example of how Phase 2 clinical trials should be designed to properly evaluate cytoprotective drugs with the use of imaging to confirm results," David S. Liebeskind, MD, director of the Neurovascular Imaging Research Core at UCLA, said in a statement.¹ "I congratulate the investigators and Revalesio on their results and look forward to seeing RNS60 in a Phase 3 trial."

The study, lasting 90 days, randomly assigned patients for age, National Institutes of Health Stroke Scale (NIHSS), and ASPECTS score for each 48-hour treatment. As previously reported, the study met its primary end point of safety and mortality, with similar rates of serious adverse events (SAEs) and lower number of deaths in the RNS60 group compared with placebo.

Coming into the study, patients had a NIHSS score greater than 5, an ASPECTS score greater than 5, evidenced presence of penumbra/collaterals, and a pre-stroke modified Rankin Scale (mRS) score of 2 or less. In the latest data update, given during the “Emerging Stroke Therapies and Risk Stratification” talk, results showed that 55% of patients on high-dose RNS60 were discharged to their home whereas only 21% could say the same for placebo.

READ MORE: Felix NeuroAI Wristband Demonstrates Superiority Over Sham Device in TRANQUIL Study for Essential Tremor

Using a dichotomized mRS, additional data revealed that 72% of RNS60-treated patients in the high dose cohort were independent at day 90 vs 37% of those on placebo. At 90 days, the high-dose cohort demonstrated 16% higher number of participants with mRS between 0-2 (OR, 3.7; P = .36), a higher number of participants with Barthel Index greater than 95 (high-dose: 71% vs placebo: 43%; OR, 5.8; P = .13), and improved EQ-5D-5L index score (high-dose: 0.74 [±0.13] vs placebo: 0.58 [±0.13]; P = .09) at each pre-specified time point. Furthermore, those in the RNS60 high dose cohort also had improved NIHSS score vs placebo as well.

RNS60 is an investigational therapeutic that employs a novel platform technology involving charge-stabilized nanostructures (CSNs) in saline. These nanostructures are designed to modulate cellular signaling pathways, including the regulation of inflammatory responses and oxidative stress, without the use of traditional pharmacological agents. RNS60 has been studied for its potential neuroprotective and anti-inflammatory effects, particularly in neurodegenerative and autoimmune conditions like multiple sclerosis, amyotrophic lateral sclerosis (ALS), and Alzheimer disease. By targeting dysregulated immune and cellular processes, RNS60 aims to provide a safer and innovative approach to treating diseases associated with chronic inflammation and oxidative damage.

A previously conducted phase 2 study of RNS60 in patients with ALS, published in the European Journal of Neurology, demonstrated positive effects on respiratory and bulbar function. Over 24 weeks of treatment, patients receiving RNS60 showed a slower decline in forced vital capacity (FVC) compared with placebo (difference, 0.41 per week; P = .0101) and significant improvement in the eating and drinking domain of the ALS Assessment Questionnaire-40 (difference, –0.19 per week; P = .0319). Additionally, a post-hoc analysis revealed that neurofilament light chain remained stable in bulbar-onset patients treated with RNS60 but increased in those on placebo.³

Revalesio announces new analyses from Phase 2 RESCUE study assessing RNS60 in acute ischaemic stroke

 You'll have to ask your competent? doctor which of the 5 causes of the neuronal cascade of death in the first week is being addressed! 

I wish they had used the proper term; penumbra, and specified exactly how many millions of neurons were saved.

I consider the Rankin scale useless, not objective except for #6, dead?

NIHSS and the Berthel Index ARE NOT DAMAGE DIAGNOSES, they do not give you the 3d location of your dead and damaged neurons. In my opinion, they are FUCKING WORTHLESS to getting you recovered! 

The latest here:

Revalesio announces new analyses from Phase 2 RESCUE study assessing RNS60 in acute ischaemic stroke

Revalesio has announced new analyses of the completed Phase 2 RESCUE clinical trial evaluating its drug candidate RNS60 in acute ischaemic stroke that demonstrate a nominally significant lowering of infarct growth in patients treated less than 12 hours from last known well. The lowering of infarct growth correlated with clinically meaningful improvements in several functional stroke measures for assessing a patient’s recovery(None of which are worth a damn, about helping you get recovered!), including the modified Rankin scale (mRS), Barthel index (BI), and National Institutes of Health stroke scale (NIHSS), the company claims in a recent press release.

These results were delivered during an oral presentation at the ongoing International Stroke Conference (ISC; 5–7 February, Los Angeles, USA).

“This analysis of the RESCUE trial adds further information regarding the beneficial effects of RNS60, confirming that it has favourable effects on MRI [magnetic resonance imaging]-confirmed ischaemic lesion growth that translated into improved clinical outcomes,” said former World Stroke Organization (WSO) president Marc Fisher (Beth Israel Deaconess Medical Center, Boston, USA). “These are exciting results that suggest that RNS60 should be evaluated in a large Phase 3 clinical trial that will hopefully confirm its benefits and lead to approval as the first therapeutic agent in decades to demonstrate significant efficacy in improving outcomes for acute ischaemic stroke patients.”

In RESCUE—a multicentre, double-blinded, placebo-controlled, randomised Phase 2 clinical trial—Revalesio evaluated the safety and initial efficacy of RNS60. Eighty-two participants with acute ischaemic stroke eligible for endovascular therapy (EVT) were enrolled and received either intravenous RNS60 0.5mL/kg/h (low dose), RNS60 1mL/kg/h (high dose), or placebo, starting before completion of EVT and continuing for 48 hours.

The trial had two primary endpoints: safety and mortality. Secondary endpoints for the study assessed disability based on mRS scores, changes in the size of the stroke measured via MRI at 48 hours, and additional standard stroke scales like BI and NIHSS.

Highlights from the oral presentation—given by Revalesio’s acting chief medical officer Jordan Dubow on 5 February at ISC 2025—are as follows:

• The high dose of RNS60 significantly lowered infarct growth by 50% (nominal p<0.05) when compared to placebo, based on imaging performed at approximately 48 hours compared to immediately post-EVT, both in patients treated within 12 hours and 24 hours of last known well
• The high dose of RNS60 was also numerically better than placebo for each prespecified functional endpoint at day 90 (mRS, with 72% of subjects on high-dose RNS60 being independent [mRS 0–2] at day 90 compared to 37% on placebo; BI, with 72% of subjects on high-dose RNS60 returning to normal activities of daily living [BI³ 95] compared to 37% on placebo; and patient health status as measured by the EQ-5D-5L index, with 1 being ideal, which was 0.79 for RNS60 subjects and 0.57 for placebo)
• RNS60 was safe and well tolerated

“As the number-one cause of disability worldwide, the impact of stroke is staggering, accounting for US$721 billion annually to the global healthcare system,” said Bert van den Bergh, Revalesio’s executive chairman of the board of directors. “Additionally, more than 80% of patients in the USA have no treatment options following a stroke, underscoring the significant need for new and effective treatment options. These highly encouraging results further demonstrate the potential of RNS60 to greatly reduce the likelihood of disability in patients following a stroke, and we plan to advance RNS60 into a Phase 3 clinical trial in order to bring this promising therapy to patients.”

Initial topline results from the RESCUE Phase 2 study—which evaluated patients who were 24 hours from last known well, and saw RNS60 meet its safety- and mortality-related endpoints—were presented as a late-breaking oral presentation at last year’s ISC (7–9 February 2024, Phoenix, USA).