Remedy Pharmaceuticals to Showcase Groundbreaking Phase 3 CHARM Study Data on CIRARA® at International Stroke Conference 2025

NEW YORK, Jan. 29, 2025 /PRNewswire/ -- Remedy Pharmaceuticals, the developer of CIRARA (intravenous glyburide) for the treatment of Large Hemispheric Infarction (LHI) today announced three speaker presentations of efficacy data from both the Phase 2 GAMES-RP and Phase 3 CHARM study on its stroke drug, CIRARA, will be presented at the upcoming International Stroke Conference (ISC) being held February 5–7, 2025 at the Los Angeles Convention Center.

The presentations will focus on efficacy results from the GAMES-RP and CHARM studies and their implications for improving outcomes in patients with LHI.

1. Meta-Analysis of CIRARA's Efficacy:

Glyburide for Large Hemispheric Infarcts ≤ 125 mL: A Meta-Analysis of Individual Patient Data from GAMES-RP and CHARM Trials, 

Time: February 5, 2025, from 8:18 a.m. to 8:30 a.m.

Details: Features a meta-analysis evaluating CIRARA's efficacy in treating LHI's with core lesion volumes 125 mL or smaller by combining data from the GAMES-RP and CHARM trials.

Presenter: W. Taylor Kimberly, MD, PhD., Chief, Division of Neurocritical Care at Massachusetts General Hospital, Associate Professor of Neurology at Harvard Medical School and co-principal investigator on the GAMES-RP and CHARM studies.

2. Endovascular Treatment Outcomes:

Intravenous Glyburide in Large Core, Endovascular-Treated Stroke Patients: An Analysis of the CHARM Trial.

Time: February 5, 2025, from 3:42 p.m. to 3:54 p.m. in Room 515B.

Presenter: Kevin Sheth, MD, Professor of Neurology and Neurosurgery and a Director of the Yale Center for Brain & Mind Health, and co-principal investigator on the GAMES-RP and CHARM studies.

Details: The presentation will examine CIRARA's potential to improve outcomes in LHI patients treated with endovascular therapy (EVT).

3. Long-Term Outcomes:

Long Term Outcomes in the CHARM Trial: Evaluating Intravenous Glyburide for the Treatment of Large Hemispheric Infarction.

Time: February 6, 2025, from 3:42 p.m. to 3:54 p.m. in Room 515B.

Presenter: Kevin Sheth.

Details: The presentation will highlight 6 and 12-month outcomes from the CHARM trial.

Additionally, the invited symposium, Bench to Bedside and Beyond – Attacking the Swell: Vascular Permeability and Cerebral Edema Post-Stroke, will be held on February 6, 2025, in the afternoon in Room 515A. It will feature leading experts, including Drs. Kimberly and Sheth, discussing advancements in understanding vascular permeability and cerebral edema post-stroke, with an emphasis on translating bench research into clinical practice.

"These analyses from the CHARM and GAMES-RP trials represent a pivotal opportunity to advance the treatment landscape for Large Hemispheric Infarction," said Sven Jacobson, CEO of Remedy Pharmaceuticals. "The presentations at ISC 2025 highlight the robust efficacy of CIRARA and reinforce our commitment to improving outcomes for patients with this devastating condition."

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 (EVT) and intravenous thrombolysis (administering clot-dissolving drugs like tPA). However, the large scale of the infarction and the resultant edema leads to poorer outcomes compared to smaller strokes, with many patients suffering long-term disability or death.

About the GAMES-RP and CHARM Studies

GAMES-RP was an 86-patient double-blind, randomized, placebo-controlled Phase 2 study evaluating CIRARA in patients aged 18-85 with LHI.

The CHARM clinical trial was a double-blind, randomized, placebo-controlled Phase 3 study evaluating CIRARA in patients aged 18-85 with LHI. The trial enrolled 535 patients, including an efficacy analysis population of 431 patients aged 18-70. Treatment was initiated within 10 hours of symptom onset. The study, sponsored by Biogen, was terminated prematurely following a strategic realignment of resources, and the program has since been returned to Remedy Pharmaceuticals.

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) diseases and injuries.

To Arrange a Meeting at ISC 2025

Sven Jacobson, CEO of Remedy Pharmaceuticals, will be attending ISC. To schedule a meeting or learn more about CIRARA and its potential in treating Large Hemispheric Infarction, please reach out directly:

Contact Information:

Sven Jacobson
Email: [email protected]
Phone: 212.586.2226
Website: www.remedypharmaceuticals.com

SOURCE Remedy Pharmaceuticals