Biogen conducted the Phase III trial in patients with large hemispheric infarction but recently handed the rights to the drug back to Remedy Pharmaceuticals. Image credit: Shutterstock / Kzenon.

A stroke drug scrapped by Biogen has helped more people to walk independently 12 months after a large hemispheric infarction (LHI), the most serious form of ischaemic stroke, in a Phase III trial.

Remedy Pharmaceuticals has taken back control of the Phase III CHARM study (NCT02864953) investigating CIRARA (IV glyburide). Data released yesterday (1 October) showed that 78% of patients treated with CIRARA and endovascular thrombectomy (EVT) were able to walk independently at 12 months, compared to only 51% in the placebo group – a 55% relative increase.

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The data also showed a significant sustained effect at 12 months on the modified Rankin Scale (mRS) in patients with lesion volumes of less than 125mL with a better impact in patients who also had EVT.

The New York-based company is now looking to run a Phase III confirmatory trial of the drug, says CEO Sven Jacobson.

“These latest findings are incredibly encouraging. 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 a patient’s ability to walk independently certainly strengthens our resolve as we move forward with a confirmatory Phase III study,” Jacobson said.

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The study was terminated by its original sponsor Biogen in a ‘strategic realignment of resources’, with the biotech handing the programme back to Remedy. Biogen originally acquired the candidate from Remedy in May 2017. In addition, Biogen appears to be moving away from the stroke space after selling its acute ischemic stroke drug BIIB131 to Ji Xing in January 2024.

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The CHARM trial was a double-blind, randomised, placebo-controlled study in 535 patients aged 18-85 years with LHI. Patients were eligible to be enrolled in the trial if they could be dosed with the drug within ten hours after being considered ‘well’, classified as pre-stroke with no symptoms. LHI is characterised by large-volume lesions that lead to malignant brain swelling, severe disability, and death.

Previous data announced in May 2024 showed that with an NIH Stroke Scale (NIHSS) of less than or equal to 20, CIRARA improved outcomes with an odds ratio of 1.8 at day 90. Post hoc analysis of patients with a lesion volume less than 125mL found an odds ratio of 2.2 in favour of CIRARA, increasing a ratio of 7.1 in patients who also had EVT.

In January 2017, the US Food and Drug Administration granted CIRARA orphan drug designation for severe cerebral oedema in patients with acute ischaemic stroke.