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NEW YORK, Oct. 1, 2024 /PRNewswire/ -- Remedy Pharmaceuticals today announced additional promising data from the Phase 3 CHARM clinical trial of CIRARA (IV glyburide) in patients with Large Hemispheric Infarction (LHI), the most serious form of ischemic stroke, characterized by large-volume lesions that lead to malignant brain swelling, severe disability, and death. This latest analysis revealed that CIRARA demonstrated a significant, sustained effect at 12 months on the modified Rankin Scale (mRS) in patients with lesion volumes <125 mL. The odds ratio for CIRARA's effect across all <125 mL lesion volume patients was 2.22 (p=0.03), and in patients who also received endovascular thrombectomy (EVT), the odds ratio was even higher at 6.92 (p=0.02). The sustained effect of CIRARA over time is further exemplified by the fact that 78% of EVT patients treated with CIRARA were able to walk independently at 12 months, compared to only 51% in the placebo group—representing a 55% relative increase in this important outcome. In May 2024, Remedy announced that in the prespecified modified intent-to-treat (mITT) population with NIH Stroke Scale (NIHSS) ≤ 20 (n=274), CIRARA improved outcomes with an odds ratio of 1.8 (p=0.01) at Day 90. A post hoc analysis of patients with a lesion volume <125 mL (n=118) found an odds ratio of 2.2 in favor of CIRARA (p=0.04), while in the EVT population with lesion volumes <125 mL (n=34), the odds ratio was 7.1 (p=0.01). Further post hoc analysis showed that CIRARA significantly increased the likelihood of achieving an mRS score of 0-3 (indicating moderate disability or better) in patients with a lesion volume <125 mL (n=118), with an odds ratio of 4.1 (p<0.01). An mRS score of 0-3 includes the ability to ambulate independently—a highly desirable outcome. Among EVT patients with lesion volumes <125 mL (n=34), CIRARA's odds ratio for achieving an mRS score of 0-3 was an impressive 18.5 (p=0.03). "These latest findings are incredibly encouraging," said Sven Jacobson, CEO of Remedy Pharmaceuticals. "CIRARA continues to demonstrate its potential to dramatically improve outcomes for patients suffering from severe ischemic stroke. The ability to show sustained effects through one year and the profound impact on patients' ability to walk independently certainly strengthens our resolve as we move forward with a confirmatory Phase 3 study." About the CHARM Study The CHARM clinical trial was a multicenter, multinational, double-blind, randomized, placebo-controlled Phase 3 study involving patients aged 18-85 with LHI. Patients were eligible if the study drug was expected to start within 10 hours after they were last known well. A total of 535 patients were enrolled, including 431 patients aged 18-70 (the efficacy analysis population) and 81 patients aged 71-85. The study, which was sponsored by Cambridge-based Biogen, was terminated early after a strategic realignment of resources, leading to the return of the program to Remedy. About Remedy Pharmaceuticals: New York-based Remedy Pharmaceuticals, Inc. is a privately held, clinical-stage pharmaceutical company focused on developing and bringing lifesaving treatments to people affected by acute central nervous system (CNS) diseases and injuries. Remedy is planning a confirmatory Phase 3 study of CIRARA in LHI. Contact: Sven Jacobson CEO Remedy Pharmaceuticals 212.586.2226 [email protected] SOURCE Remedy Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Expands reach beyond Pittsburgh; exceeds $2 Million awarded since Inception PITTSBURGH, Oct. 6, 2022 /PRNewswire/ -- The Chuck Noll Foundation for Brain Injury Research has announced $452,000 in new grants that have been awarded to support brain injury research. The foundation, which provides early-stage research grants to improve the diagnosis, treatment, and prevention of brain injuries primarily from sports, has now funded 18 research projects, providing more than $2 million in early stage grants since 2016. Continue Reading "With a focus on research, related to diagnosis and treatment, we are excited about the potential this round of grants has to impact the lives of people who face brain injuries," said Chairman Arthur J. Rooney, II, President of the Pittsburgh Steelers and Chairman of the Foundation Board. "With each cycle, researchers are given the opportunity to break scientific boundaries in brain injury research and we're grateful to our supporters for their commitment." "Funding for pilot studies is highly coveted...emerging investigations have immense potential..." Tweet this This cycle marks the first in which the organization has provided grants beyond its headquarters of Pittsburgh, expanding its reach nationally. "Funding for pilot studies is highly coveted and remains limited but emerging investigations have immense potential to impact our understanding of an individual's brain," said Dr. Nitin Agarwal formerly at the University of Pittsburgh Medical Center now with the Washington University School of Medicine. This research project is focused on developing a non-invasive imaging biomarker that can identify optimal treatments and predict better outcomes for people with brain injuries. This type of research depends on a foundation like The Chuck Noll Foundation, which has a unique and distinct focus on early stage research. This work has enormous potential to impact people with injuries and is delivering exciting results. The Chuck Noll Foundation opened its call for proposals beyond Pittsburgh for the first time in the spring of 2022. "Anywhere between 1.7 and 3 million people are impacted by sports-related brain injuries annually in our country. This is why the interest in our work has been strong and important." explained John Denny, executive director. "As we work to diminish the impact of sports-related head injuries, our latest cycle attracted research proposals from across the nation as well as internationally. Beyond our direct grants, our research projects have led to the leveraging of an additional $12 million, creating a ripple effect of impact." "Due to the quality, the success and the multiplier effect of our grants, we have now expanded requests for proposals nationally," said Dr. Joseph C. Maroon, Chair of the foundation's National Science Advisory Committee. The new research grants include: Institution: Washington University School of Medicine Title: "Identifying occult traumatic brain injury in professional athletes using a novel non-invasive biomarker" Researcher: Nitin Agarwal Amount: $125,000 Institution: University of Pittsburgh and Barrow Neurological Institute Title: "Sulfonylurea Receptor-1 and Glyburide: A Single-Cell Precision Medicine Approach to Preventing Brain Swelling and Providing Neuroprotection for the Second Impact Syndrome" Researchers: Patrick M. Kochanek and Ruchira M. Jha, Principal Investigators Amount: $125,000 Institution: UPMC, University of Pittsburgh Title: "Impact of obesity on blood-based biomarkers and recovery trajectories following mild traumatic brain injury" Researchers: Shawn R. Eagle and David O. Okonkwo Amount: $125,000 Institution: The Pennsylvania State University Title: "Examining the link between finite element-based strain predictions and cognitive changes." Researcher: Reuben Kraft, Principal Investigator Amount: $77,589 Prior grantees include Allegheny General Health, Carnegie Mellon University and the University of Pennsylvania. For more information on the specific grants or the organization, go to: About the Chuck Noll Foundation for Brain Injury Research: Established in 2016 through a grant from the Pittsburgh Steelers, The Chuck Noll Foundation for Brain Injury Research was established to diminish the impact of sports related head injuries. The organization provides early stage research grants to improve the diagnosis, treatment, and prevention of brain injuries that include more than $2 million in early stage grants since its inception, spurred by an additional $12 million from other sources. Noll enjoyed a 23-year coaching career with the Steelers and held a deep commitment to the well-being of his players, which led to the development of the ImPACT test (Immediate Post-Concussion Assessment and Cognitive Testing). Since 2007, this test has become a model used by NFL team doctors, and now internationally, to help monitor concussions for athletes at all levels. For more information: Contact: Anna Havrilla [email protected] (412) 913-3343 SOURCE Chuck Noll Foundation for Brain Injury Research