Remedy Pharmaceuticals Secures Key U.S. Patent Allowance for CIRARA® in Treating Large Hemispheric Infarction, Including Wake-Up Strokes

NEW YORK, March 18, 2025 /PRNewswire/ -- Remedy Pharmaceuticals, a leader in stroke drug development, today announced that the U.S. Patent and Trademark Office (USPTO) has allowed two additional patents covering its large hemispheric infarction (LHI) drug, CIRARA (IV glyburide). 

The allowances include a claim covering the use of CIRARA's active pharmaceutical ingredient, glyburide, or any other SUR1-TRPM4 inhibitor, to treat patients with a LHI and a lesion volume of 50-125 mL who undergo endovascular therapy (EVT), a minimally invasive mechanical procedure used to remove blood clots from large arteries in the brain. EVT has recently become the standard of care in treating LHI. Clinical evidence has shown that CIRARA is highly effective in combination with EVT in this lesion range, with an Odds Ratio of 8.19 (p=0.01) favoring CIRARA treatment over placebo.

"This claim covers the treatment of patients expected to be included in the primary analysis group of any Phase 3 study designed to gain regulatory approval," says Sven Jacobson, CEO of Remedy Pharmaceuticals, "and the allowance aligns with current clinical standards for treating LHI patients."

The allowances also relate to the use of CIRARA's active pharmaceutical ingredient, glyburide, or any other SUR1-TRPM4 inhibitor, to treat wake-up stroke patients undergoing EVT. Wake-up strokes, which account for 20-25% of all strokes, occur during sleep, such that patients awaken with symptoms that were absent at bedtime. In the CHARM study, patients receiving CIRARA in this subgroup were nearly six times more likely to achieve a favorable outcome compared to those on placebo (Odds Ratio: 5.7, p=0.01).

Additionally, the allowances cover the use of Remedy's proprietary formulation of glyburide (CIRARA) to treat patients with LHI who experience a wake-up stroke and present with a NIH Stroke Scale Score (NIHSS) ≤ 20, irrespective of whether the patient undergoes EVT. The NIHSS is a widely used measure of stroke severity, with a score of 20 representing the boundary of "moderate-to-severe" strokes.

"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."

Both patents provide coverage through June 2044, with the possibility of extending one to June 2049.

About Large Hemispheric Infarction

A large hemispheric infarction is a particularly severe type of ischemic stroke that affects a substantial portion of the brain. Treatment for LHI typically involves rapid revascularization strategies to restore blood flow, such as mechanical thrombectomy or intravenous thrombolysis. However, the large scale of the infarction and the resultant severe edema leads to poorer outcomes compared to smaller strokes, with many patients suffering long-term disability or death.

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) injuries.

Contact:
Sven Jacobson
CEO
Remedy Pharmaceuticals
212.586.2226
[email protected]
www.remedypharmaceuticals.com

SOURCE Remedy Pharmaceuticals