NEW YORK, Sept. 3, 2024 /PRNewswire/ -- Remedy Pharmaceuticals today announced promising new data from the Phase 3 CHARM clinical trial of CIRARA (IV glyburide) in 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. The analysis revealed significant and clinically meaningful improvements in patients’ ability to ambulate independently following administration of CIRARA, particularly when used in combination with endovascular thrombectomy (EVT).
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 was terminated early by Cambridge-based Biogen after a strategic realignment of resources, leading to the return of the program to Remedy.
In May 2024, Remedy conducted prespecified subgroup analyses, along with post hoc analyses examining the impact of lesion volume on outcomes, which revealed significant improvements in functional outcomes on the modified Rankin Scale (mRS) at 90 days. Specifically, in the prespecified modified Intent to Treat (mITT) population with NIH Stroke Scale (NIHSS) ≤ 20 (n=274), CIRARA improved outcomes with an Odds Ratio (OR) of 1.8, p=0.01. In a post hoc analysis of patients with CTP/MRI lesion volume <125 mL (n=118), the OR for improved 90-day outcome was 2.2 in favor of CIRARA (p=0.04). Additionally, in the EVT population with CTP/MRI lesion volume <125 mL (n=34), the OR was 7.1 in favor of CIRARA (p=0.01).
Further post hoc analyses have now been performed and show that the OR for achieving an mRS score of 0-3 (moderate disability or better) in patients with a lesion volume < 125 mL (n=118) was 4.1 in favor of CIRARA (p<0.01). An mRS of 0-3 reflects no greater than moderate disability, which includes the ability to ambulate independently, a highly desirable outcome.
In the mITT EVT population with a lesion volume <125 mL (n=34), the OR for achieving an mRS score of 0-3 was 18.5 in favor of CIRARA (p=0.03), indicating an even more dramatic improvement in functional outcomes, particularly in the ability to ambulate independently.
“These new findings are incredibly encouraging and provide strong evidence that CIRARA could be a game-changer in the treatment of large hemispheric infarction,” said Sven Jacobson, CEO of Remedy Pharmaceuticals. “The significant improvements in functional outcomes, and particularly the increased rates of independent ambulation, highlight the potential of CIRARA to revolutionize stroke care and offer new hope to patients and their families.”
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
sven@remedypharmaceuticals.com
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SOURCE Remedy Pharmaceuticals
