The US Patent and Trademark Office (USPTO) has allowed two new patents for Remedy Pharmaceuticals’ Cirara to treat large hemispheric infarction (LHI).
The allowances encompass a claim for using Cirara’s active ingredient, glyburide, to treat LHI patients with lesion volumes between 50ml and 125ml who are undergoing endovascular therapy (EVT).
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Remedy Pharmaceuticals CEO Sven Jacobson stated: “This claim covers the treatment of patients expected to be included in the primary analysis group of any Phase III study designed to gain regulatory approval and the allowance aligns with current clinical standards for treating LHI patients.
“These latest allowances strengthen our already extensive patent portfolio,” notes Jacobson, “and further validate Cirara’s potential to transform LHI stroke care for patients who currently have limited options.”
Based on clinical evidence, it was observed that the drug is highly effective when used with EVT in the lesion range, with an odds ratio of 8.19 favouring its treatment over a placebo.
EVT is a minimally invasive mechanical procedure for removing blood clots from large arteries in the brain.
Patents extend to the use of the drug for wake-up stroke sufferers receiving EVT.
These strokes, which make up 20% to 25% of all strokes, have individuals waking up with stroke symptoms that were not present before sleep.
In the CHARM trial, the administration of the drug to this subgroup resulted in a nearly sixfold increase in the likelihood of favourable results against the placebo group.
The patents also cover the use of the company’s glyburide formulation for treating LHI patients who suffer a wake-up stroke and have an NIH Stroke Scale Score (NIHSS) of 20 or below, regardless of EVT.
The NIHSS is a standard scale for assessing stroke severity, with a score of 20 indicating moderate to severe strokes.
These patents are protected until June 2044, with the option to extend one until June 2049.
