Remedy Pharmaceuticals announced that the Food and Drug Administration (FDA) has granted Fast Track designation to Cirara for the treatment of large hemispheric infarctions (LHI).
LHI is a type of ischemic stroke associated with a high likelihood of developing life-threatening cerebral edema caused by the opening of Sur1-Trpm4 channels in the capillary endothelium. This leads to compromised arterial inflow to surrounding tissues, causing further ischemic damage and infarct enlargement frequently resulting in brain herniation and death.
The FDA recently accepted the investigational new drug (IND) application for Cirara. Remedy expects to initiate the Phase 3 study, CHARM (Cirara in large Hemispheric infarction Analyzing modified Rankin & Mortality), in patients with LHI by the end of this year.
Cirara is an investigational, injectable, high affinity inhibitor of Sur1-Trpm4 channels utilizing Remedy’s proprietary MPD technology.
For more information visit Remedypharmaceuticals.com.