A more than three-fold reduction in mortality in patients ≤70 years old; adjudicated neurological mortality reduced more than three-fold, and death from edema reduced 10-fold.
Results Provide Additional Basis for Planned U.S. Phase 3 Trial in Large Hemispheric Stroke
NEW YORK, Feb. 22, 2016 (GLOBE NEWSWIRE) -- Remedy Pharmaceuticals, a privately-held, phase 3-ready pharmaceutical company focused on bringing life saving hospital-based treatment to people affected by central nervous system (CNS) related edema, today announced additional efficacy data from its Phase 2 trial of CIRARA™ for preventing edema (brain swelling) in patients with large hemispheric stroke. The results were presented by the study’s two principal investigators, Kevin N. Sheth, MD of Yale University and W. Taylor Kimberly, MD of Massachusetts General Hospital, in two oral presentations during the International Stroke Conference (ISC) 2016, held February 17-19, 2016 at the Los Angeles Convention Center in Los Angeles, California.
CIRARA is the Company’s lead product candidate for the treatment of CNS-related edema. The GAMES-RP study was a prospective double-blind, randomized, placebo-controlled Phase 2 trial comparing CIRARA to placebo. Top line results had previously been presented at the Neurocritical Care Society annual general meeting in October 2015 and announced by Remedy in a press release.
The additional analyses presented at ISC included adjudicated mortality, 6-month functional outcome data, and a post hoc analysis in patients 70 years or younger.
Adjudicated neurological mortality was reduced from 25% in placebo to 7% in CIRARA-treated patients (p=0.03), a more than three-fold reduction in mortality, and death from edema (swelling) was reduced from 22% in placebo to 2% in CIRARA-treated patient (p=0.008), or a ten-fold decrease.
In a pre-specified “shift analysis”, there was a trend towards improved 6-month functional (modified Rankin Scale or mRS) scores (p=0.13). The sizable reduction in mortality exhibited at 90 days remained at six months (20% in placebo versus 39% in the CIRARA group, p=0.06)
In patients 70 and younger, 90-day functional outcomes were statistically significantly improved across the board (p=0.048), and 90-day mortality was dramatically reduced from 33% in the placebo group to 12% in the CIRARA group (p=0.03). This difference persisted at six months (37% vs. 14%, p=0.04).
Sven Jacobson, CEO of Remedy Pharmaceuticals, said, “This exciting six-month data shows a continued reduction in mortality and improvement in functional scores, the adjudicated mortality data further confirms the mechanism of action of CIRARA, and the robust signal in patients 70 and under suggests an even larger effect in younger patients. This additional data is very helpful as we move forward with the design of our planned Phase 3 trial.”
ABOUT CIRARA™
CIRARA™ is a patented, high affinity inhibitor of Sur1-Trpm4 channels suitable for intravenous delivery at the bedside or even in an ambulance. CIRARA uses our proprietary, patented MPD™ technology. CIRARA is an investigational drug and is not approved by FDA.
ABOUT REMEDY PHARMACEUTICALS
Remedy Pharmaceuticals, Inc. is a privately-held, clinical stage pharmaceutical company focused on developing and bringing lifesaving treatment to millions of people affected by acute central nervous system (CNS) edema – including stroke, traumatic brain injury, spinal cord injury, as well as other ischemic injuries and neurological disorders.