Remedy Pharmaceuticals is set to present new efficacy data on CIRARA (intravenous glyburide) for the treatment of Large Hemispheric Infarction (LHI) at the International Stroke Conference (ISC) February 5–7, 2025, in Los Angeles. The presentations will feature findings from the Phase 2 GAMES-RP and Phase 3 CHARM studies, offering insights into CIRARA's potential to improve outcomes for patients with this severe form of stroke.
The data includes a meta-analysis of the GAMES-RP and CHARM trials, which evaluates CIRARA's efficacy in treating LHI with core lesion volumes of 125 mL or smaller. W. Taylor Kimberly, MD, PhD, from Massachusetts General Hospital and Harvard Medical School, will present this analysis. The study combines data from both trials to provide a more comprehensive understanding of CIRARA's impact on this specific patient subgroup.
CIRARA and Endovascular Treatment
Another presentation by Kevin Sheth, MD, from Yale Center for Brain & Mind Health, will focus on the outcomes of LHI patients treated with endovascular therapy (EVT) who also received CIRARA. This analysis of the CHARM trial explores whether CIRARA can enhance the benefits of EVT, a common revascularization strategy for LHI.
Long-Term Outcomes from CHARM Trial
Dr. Sheth will also present data on the long-term outcomes from the CHARM trial, evaluating the effects of intravenous glyburide on patients with LHI at 6 and 12 months post-treatment. This presentation will provide insights into the sustained benefits of CIRARA on functional outcomes and overall recovery.
Bench to Bedside Symposium
In addition to the data presentations, Drs. Kimberly and Sheth will participate in an invited symposium titled "Bench to Bedside and Beyond – Attacking the Swell: Vascular Permeability and Cerebral Edema Post-Stroke." This session will feature leading experts discussing advancements in understanding vascular permeability and cerebral edema following a stroke, with a focus on translating bench research into clinical practice.
About the CHARM and GAMES-RP Studies
The GAMES-RP study was an 86-patient, double-blind, randomized, placebo-controlled Phase 2 trial assessing CIRARA in LHI patients aged 18-85. The CHARM trial was a larger Phase 3 study with a similar design, enrolling 535 patients, including an efficacy analysis population of 431 patients aged 18-70. Treatment was initiated within 10 hours of symptom onset. Although Biogen initially sponsored the CHARM study, the program has since been returned to Remedy Pharmaceuticals.
"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."
