FDA Grants Fast Track for Remedy Pharma’s Cirara

FDA has granted Remedy Pharmaceuticals a fast track designation for its investigational drug Cirara and its use in treating large hemispheric infarctions (LHI). The company is planning a Phase 3 trial called CHARM (Cirara in large Hemispheric infarction Analyzing modified Rankin & Mortality) in patients with LHI, a disease associated with significant disability and mortality. Brain swelling frequently occurs following LHI as a result of the “opening of Sur1-Trpm4 channels in the capillary endothelium, which leads to dysfunction of the blood brain barrier,” the company says. Such swelling can compromise arterial inflow to surrounding tissues, causing further ischemic damage and enlargement of the infarct, and frequently results in brain herniation and death. Remedy says Cirara is a high affinity inhibitor of Sur1-Trpm4 channels, which are upregulated following ischemia and trauma.