Phase 3 Trial by Remedy Pharmaceuticals Shows Significant One-Year Effect in Large Lesion Stroke Patients

Remedy Pharmaceuticals has unveiled promising new data from their Phase 3 CHARM clinical trial of CIRARA (IV glyburide) for patients suffering from Large Hemispheric Infarction (LHI), a severe form of ischemic stroke. This condition is marked by large-volume brain lesions that cause significant swelling, severe disability, and often death.

The recent analysis showed CIRARA has a significant, long-lasting impact on the modified Rankin Scale (mRS) at 12 months for patients with lesion volumes smaller than 125 mL. For these patients, the odds ratio for positive outcomes with CIRARA was 2.22 (p=0.03). The odds ratio surged to 6.92 (p=0.02) for those who also underwent endovascular thrombectomy (EVT).

Moreover, 78% of EVT patients treated with CIRARA could walk independently after 12 months, compared to only 51% in the placebo group, indicating a 55% improvement in this critical measure. Earlier in May 2024, Remedy Pharmaceuticals reported that for the prespecified modified intent-to-treat (mITT) population with an NIH Stroke Scale (NIHSS) score of 20 or lower (n=274), CIRARA improved outcomes with an odds ratio of 1.8 (p=0.01) at Day 90. A subsequent analysis of patients with lesion volumes under 125 mL (n=118) revealed an odds ratio of 2.2 in favor of CIRARA (p=0.04). For EVT patients with lesion volumes under 125 mL (n=34), the odds ratio escalated to 7.1 (p=0.01).

Further post hoc analysis indicated that CIRARA substantially increased the chances of achieving an mRS score of 0-3, which signifies moderate disability or better, in patients with lesion volumes less than 125 mL (n=118). The odds ratio for this group was 4.1 (p<0.01). For EVT patients within the same lesion volume range (n=34), the odds ratio for achieving an mRS score of 0-3 was an extraordinary 18.5 (p=0.03).

Sven Jacobson, CEO of Remedy Pharmaceuticals, expressed optimism about these findings. He emphasized that CIRARA continues to show its potential to significantly improve outcomes for severe ischemic stroke patients. The sustained effects seen over a year and the marked improvement in patients' mobility strengthen the company's commitment to proceeding with a confirmatory Phase 3 study.

The CHARM clinical trial was a comprehensive, multicenter, multinational, double-blind, randomized, placebo-controlled Phase 3 study. It included patients aged 18-85 with LHI who could start the study drug within 10 hours of their last known well time. The trial enrolled a total of 535 patients, with 431 aged 18-70 (the efficacy analysis population) and 81 aged 71-85. Sponsored by Biogen, the study was terminated prematurely due to strategic shifts, prompting the return of the program to Remedy Pharmaceuticals.

Remedy Pharmaceuticals is a New York-based, privately held, clinical-stage pharmaceutical company dedicated to developing treatments for acute central nervous system (CNS) diseases and injuries. The company plans to initiate a confirmatory Phase 3 study of CIRARA in LHI.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!