This post was originally published on this site
NEW YORK, Feb. 18, 2025 /PRNewswire/ — Remedy Pharmaceuticals, a leader in stroke drug development today announced efficacy data from the Phase 2 GAMES-RP and Phase 3 CHARM studies of CIRARA (intravenous glyburide) for the treatment of Large Hemispheric Infarction (LHI) presented at the International Stroke Conference (ISC) held February 5–7, 2025.
Results were unveiled across five presentations given by the co-principal investigators on the GAMES-RP and CHARM studies, W. Taylor Kimberly, MD, PhD., Chief, Division of Neurocritical Care at Massachusetts General Hospital, Associate Professor of Neurology at Harvard Medical School and Kevin Sheth, MD, Professor of Neurology and Neurosurgery and a Director of the Yale Center for Brain & Mind Health.
Effects of CIRARA in the 147-patient sub-population of the Phase 3 CHARM study with a quantitative lesion volume assessment on CTP/MRI ≤ 125 mL showed a robust effect that was further confirmed when combined with the phase 2 GAMES-RP trial data. In addition, the 34-patient EVT ≤ 125 mL population from CHARM demonstrated the strongest effect. The analyses were adjusted for NIHSS (continuous), age (continuous), thrombolysis (Y/N), EVT (Y/N) and region. Odds Ratio (OR) calculations indicate the effect size of CIRARA on the modified Rankin Scale (mRS).
Key findings were as follows:
- In the CHARM ≤ 125 mL subgroup, baselines were well-balanced between the CIRARA and placebo groups, and the overall OR for drug effect at 90 days was 2.11 (1.1-4.01), p=0.02. The effect of CIRARA was durable, and the OR for drug effect at 12-months using multiple imputations for missing data was 2.21 (1.13-4.31), p=0.02.
- In the CHARM ≤ 125 mL undergoing EVT subgroup, baseline variables of the CIRARA and placebo groups were again well-balanced and the overall Odds Ratio (OR) for drug effect at 90 days was 8.19 (1.60-42.0), p=0.01. Ninety days post stroke, twice as many patients treated on drug were able to walk independently (p=0.02), a critical measure of functional recovery that directly impacts quality of life, long-term care needs, and overall independence. Additionally, mortality was reduced substantially in the CIRARA arm vs. placebo (5.6% vs. 31%, p=0.05), there were fewer decompressive craniectomies in the CIRARA arm vs. placebo (0 vs. 4, p=0.02), and midline shift was reduced vs. placebo (4.2mm vs. 7.6 mm, p=0.02). The effect was durable, and the OR at 12 months was 5.52 (1.05-28.9), p=0.04.
- The pooled analysis of patients from the Phase 2b (GAMES-RP) and Phase 3 (CHARM) studies was consistent with the findings in CHARM, with CIRARA exhibiting an effect size of 2.42 (1.3 – 4.6), p=0.007 at 90 days.
“These findings are a major step forward in understanding how CIRARA can change the trajectory for patients with large hemispheric infarction,” states Dr. Kimberly.
“The durability of the effect at 12 months underscores CIRARA’s potential as a game-changer in LHI therapy,” notes Dr. Sheth.
“These analyses from the CHARM and GAMES-RP trials are truly exciting,” said Sven Jacobson, CEO of Remedy Pharmaceuticals. “With a well-defined patient population and strong clinical signals, we are eager to advance CIRARA into a confirmatory Phase 3 study.”
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 (and 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 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) injuries.
Contact Information:
Sven Jacobson
Email: sven@remedypharmaceuticals.com
Phone: 212.586.2226
Website: www.remedypharmaceuticals.com
SOURCE Remedy Pharmaceuticals
