CIRARA Could Improve Independent Ambulation in Large Hemispheric Infarction Patients, Phase 3 Analysis Shows

Remedy Pharmaceuticals recently unveiled new data from the Phase 3 CHARM clinical trial investigating CIRARA (IV glyburide) for Large Hemispheric Infarction (LHI), a severe form of ischemic stroke marked by extensive brain lesions causing significant swelling, disability, and mortality. The findings indicate notable improvements in patients' ability to walk independently when CIRARA is administered, especially in conjunction with endovascular thrombectomy (EVT).

The CHARM trial, a multinational, double-blind, placebo-controlled study, enrolled 535 patients aged 18-85 who began treatment within 10 hours of stroke onset. Of these, 431 patients aged 18-70 formed the primary efficacy analysis group, while 81 patients aged 71-85 were also included. Cambridge-based Biogen initially managed the study but terminated it early due to a strategic resource shift, transferring the program back to Remedy Pharmaceuticals.

In May 2024, Remedy Pharmaceuticals conducted various subgroup and post hoc analyses. These analyses showed significant functional improvements on the modified Rankin Scale (mRS) at 90 days. In the modified Intent to Treat (mITT) group with a National Institutes of Health Stroke Scale (NIHSS) score of 20 or lower (n=274), CIRARA showed an Odds Ratio (OR) of 1.8 (p=0.01) for improved outcomes. In patients with a Computed Tomography Perfusion/Magnetic Resonance Imaging (CTP/MRI) lesion volume under 125 mL (n=118), the OR was 2.2 in favor of CIRARA (p=0.04). For those in the EVT group with similar lesion volumes (n=34), the OR was an impressive 7.1 (p=0.01).

Further analyses reinforced these findings, revealing that the OR for attaining an mRS score of 0-3, indicating no more than moderate disability and the ability to walk independently, was 4.1 for patients with lesion volumes under 125 mL (n=118) in favor of CIRARA (p<0.01). In the mITT EVT group with lesion volumes under 125 mL (n=34), the OR for achieving an mRS score of 0-3 was 18.5 in favor of CIRARA (p=0.03), showing even greater improvement in functional outcomes and independent ambulation.

Sven Jacobson, CEO of Remedy Pharmaceuticals, commented on the findings, stating, "These new results are extremely promising and strongly suggest that CIRARA could significantly impact the treatment of large hemispheric infarction. The notable improvements in functional outcomes and the increased rates of independent ambulation underscore CIRARA's potential to transform stroke care, offering new hope to patients and their families."

Remedy Pharmaceuticals, based in New York, is a privately held pharmaceutical company specializing in developing vital treatments for acute central nervous system (CNS) diseases and injuries. The company is planning a confirmatory Phase 3 study of CIRARA in Large Hemispheric Infarction.