RNS-60

Lowering of infarct growth – brain tissue loss – by 50% in patients treated in less than 12 hours following last known well Lowering of infarct growth correlated with clinically meaningful improvements in several functional stroke measures that evaluate a patient's recovery TACOMA, Wash., Feb. 5, 2025 /PRNewswire/ -- Revalesio, a clinical-stage pharmaceutical company developing treatments for acute and chronic neurological disorders, today announced new analyses of its completed Phase 2 RESCUE clinical trial of RNS60 in acute ischemic stroke (AIS) patients, demonstrating a nominally significant lowering of infarct growth, or brain tissue loss, in patients treated in less than 12 hours following the last time a patient was known to be well. The lowering of infarct growth correlated with clinically meaningful improvements in several functional stroke measures that evaluate a patient's recovery, including the modified Rankin Scale (mRS), Barthel Index (BI), and National Institute of Health Stroke Scale (NIHSS). These results were presented today during an oral presentation at the International Stroke Conference (ISC) 2025 in Los Angeles, CA. "This analysis of the RESCUE trial adds further information regarding the beneficial effects of RNS60, confirming that it has favorable effects on MRI-confirmed ischemic lesion growth that translated into improved clinical outcomes," said Dr. Marc Fisher, Neurologist Beth Israel Deaconess Medical Center, Harvard Medical School, and former World Stroke Organization President. "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 ischemic stroke patients." In RESCUE, a multi-center, double-blinded, placebo-controlled, randomized 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 standard stroke scales (BI and NIHSS). Highlights from the oral presentation include: RNS60 high dose 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. RNS60 high dose was also numerically better than placebo for each prespecified functional endpoint: Modified Rankin Score at Day 90: 72% of subjects on RNS60 high dose were independent (mRS of 0-2) at Day 90 compared to 37% on placebo. Barthel Index at Day 90: 72% of subjects on RNS60 high dose returned to normal activities of daily living (BI³ 95) compared to 37% on placebo. Patient Health Status at Day 90 (as measured by the EQ-5D-5L Index with 1.0 being ideal) was 0.79 for RNS60 subjects and 0.57 for placebo. RNS60 was safe and well tolerated Details of the oral presentation at ISC 2025 are below: "As the number one cause of disability worldwide, the impact of stroke is staggering, accounting for $721 billion annually to the global healthcare system. Additionally, more than 80% of patients in the U.S. have no treatment options following a stroke, underscoring the significant need for new and effective treatment options," said Bert van den Bergh, Revalesio's Executive Chairman of the Board of Directors, and former President of Neuroscience Products at Eli Lilly and Company. "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 of the RESCUE Phase 2 study were presented as a late-breaking oral presentation at ISC 2024, which evaluated patients who were 24 hours from last known well. About RNS60 RNS60 is an investigational therapeutic being developed to provide disease modifying and potentially restorative treatments for neurological diseases. In preclinical studies, RNS60 activated intracellular signaling pathways to increase mitochondrial biogenesis and function and reduce inflammation. RNS60 safely protected neurons and oligodendrocytes and modulated the activity of immune cells to restore homeostasis. About Revalesio Revalesio is a clinical-stage pharmaceutical company with a vision to change the future of treatment for acute and chronic neurological disorders. The company's lead clinical program for RNS60 is ischemic stroke with additional programs in ALS and other neurological disorders. The company's pioneering technology, founded in physics, addresses fundamental mechanisms involved with proper cellular function to slow disease progression and improve quality of life. For more information, please visit revalesio.com and engage with us on LinkedIn. Media: Lori Murray [email protected] SOURCE Revalesio Corporation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Results Presented in an Oral Presentation at the Society for Neuroscience Annual Meeting RNS60 Protected Motor Neurons and Neuromuscular Junctions and Reduced Neuroinflammation TACOMA, Wash., Oct. 9, 2024 /PRNewswire/ -- Revalesio, a clinical-stage pharmaceutical company developing treatments for acute and chronic neurological disorders, today announced new data showing that Revalesio's investigational therapeutic, RNS60, protected motor neurons in the prpTDP-43A315T-UeGFP mouse model of ALS. PrpTDP-43A315T-UeGFP mice express a mutation of the human TDP43 gene and develop progressive motor neuron degeneration, leading to gait abnormalities, muscle weakness, and eventually death, mimicking key features of ALS. TDP43-associated pathology is found in approximately 97% of people with ALS. The results were presented today during the Nanosymposium ALS Therapeutics at the Society for Neuroscience Annual Meeting. "There is a great need for treatment options to slow the progression of ALS," said Hande Ozdinler, Ph.D., Associate Professor of Neurology at Northwestern University Feinberg School of Medicine and Principal Investigator of the study. "These promising preclinical findings warrant further investigation of the potential role of RNS60 in protecting motor neurons and preserving mitochondrial function, key factors in the pathogenesis of ALS." "These exciting results suggest that RNS60 has potential to mitigate neurodegeneration due to TDP-43 pathology," said Mukesh Gautam, PhD, Research Assistant Professor of Neurology at Northwestern University Feinberg School of Medicine and presenting author at the Society for Neuroscience Annual Meeting. "Since TDP-43 pathology contributes to a large population of both familial and sporadic ALS patients, these results are particularly promising." In this study, 30-day old prpTDP-43A315T-UeGFP mice showing signs of degeneration were treated with RNS60 every other day for 60 days. Immunohistochemistry was performed to quantitatively assess activated microglia (immune cells that patrol the central nervous system [CNS] for pathogens and damage) and activated astrocytes (cells in the CNS that perform metabolic, structural, homeostatic, and neuroprotective tasks). Ultrastructural integrity of neuronal mitochondria was studied via electron microscopy. RNS60 treatment significantly a) improved mitochondrial ultrastructure in the motor neurons, b) reduced the extent of astrogliosis and microgliosis in mice and c) protected health and stability of upper motor neurons and neuromuscular junctions compared to placebo-treated mice. "These results add to the growing body of preclinical and clinical evidence that RNS60 may provide neuroprotective effects in ALS," said Bert van den Bergh, Revalesio's Executive Chairman on the Board of Directors, and former President of Neuroscience Products at Eli Lilly and Company. "We are simultaneously advancing RNS60 in planned clinical trials for the treatment of patients with ALS and ischemic stroke with the goal of improving the lives of people with these devastating conditions." About RNS60 RNS60 is an investigational therapeutic being developed to provide disease modifying and potentially restorative treatments for neurological diseases. In preclinical studies, RNS60 activated intracellular signaling pathways to increase mitochondrial biogenesis and function and reduce inflammation. RNS60 safely protected neurons and oligodendrocytes and modulated the activity of immune cells to restore homeostasis. RNS60 has been granted Orphan Drug and Fast Track designations for ALS from the U.S. Food and Drug Administration. About Revalesio Revalesio is a clinical-stage pharmaceutical company with a vision to change the future of treatment for acute and chronic neurological disorders. The company's lead clinical program for RNS60 is ischemic stroke with additional programs in ALS and other neurological disorders. The company's pioneering technology, founded in physics, addresses fundamental mechanisms involved with proper cellular function to slow disease progression and improve quality of life. For more information, please visit revalesio.com and engage with us on LinkedIn. Media Lori Murray [email protected] SOURCE Revalesio Corporation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED