Remedy Pharmaceuticals' Phase 3 Trial in Large Lesion Stroke Patients Demonstrates Statistically Significant Effect at One Year

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]
www.remedypharmaceuticals.com 

SOURCE Remedy Pharmaceuticals