Remedy Pharmaceuticals CEO Sven Jacobson said: "Our End-of-Phase 2 meeting was a decisive milestone for the Company as we advance the clinical development of CIRARA..
"We are pleased with the FDA’s guidance on our Phase 3 trial design in patients with large hemispheric stroke and we look forward to initiating the study as quickly as possible."
"There is a major unmet medical need to treat CNS-related edema," said David Geliebter, Executive Chairman of Remedy Pharmaceuticals.
"The encouraging data from our Phase 2 studies suggest CIRARA has the potential to reduce mortality and improve functional outcomes for patients with large hemispheric strokes. We’re now one step closer to achieving that goal."
About CIRARA
CIRARA is a patented, high affinity inhibitor of Sur1-Trpm4 channels, discovered by University of Maryland neurosurgeon Dr. J. Marc Simard.
CIRARA is suitable for intravenous delivery at the bedside or even in an ambulance. CIRARA uses our proprietary, patented MPD measured phase dosing technology. CIRARA is an investigational drug and is not approved by FDA.