Biogen said today it has acquired the Phase III-ready stroke treatment candidate Cirara™ (intravenous glyburide) from Remedy Pharmaceuticals for $120 million upfront.
Cirara is being developed for large hemispheric infarction (LHI), a severe form of ischemic stroke where brain swelling (cerebral edema) often leads to a disproportionately large share of stroke-related morbidity and mortality. Cirara is a high-affinity inhibitor of a specific channel that is upregulated following ischemic and traumatic injury. The treatment candidate uses Remedy’s MPD™ technology to enable optimal delivery to the injured area.
In preclinical studies, Cirara has been shown to block SUR1-TRPM4, or sulfonylurea receptor 1–transient receptor potential melastatin 4, channels that mediate stroke-related brain swelling, Biogen said, adding that clinical proof-of-concept studies have also shown the potential of the treatment to reduce brain swelling, disability, and the risk of death in patients with LHI.
In 2015, Remedy announced positive results from a Phase II study showing, in part, that mortality in patients treated with Cirara was reduced by 53% vs. placebo. Cirara has received the FDA’s Orphan Drug Designation for severe cerebral edema in patients with acute ischemic stroke, as well as the agency’s Fast Track designation.
Biogen said it plans to continue the development and commercialization of Cirara and has agreed to share in the cost of development for the treatment candidate’s target indication of LHI stroke.
Biogen agreed to pay Remedy $120 million upfront and agreed to pay undisclosed additional milestone payments and royalties.
“We believe the data supporting the potential of Cirara are compelling and that Cirara can be a first-in-class therapy that gives physicians the ability to meaningfully improve patient outcomes in an area where effective treatments have been few and far between,” Michael Ehlers, M.D., Ph.D., evp, R&D at Biogen, said in a statement. “Cirara represents a potential breakthrough stroke treatment that accelerates our efforts to build a portfolio of new therapies for neurologic diseases.”
He added that the acquisition complemented broader efforts by Biogen to build a portfolio of best-in-class treatments for acute ischemic stroke and further strengthen its leadership in neuroscience. Biogen is conducting a Phase IIb study to determine whether its monoclonal antibody Tysabri® (natalizumab)—already indicated for relapsing multiple sclerosis and Crohn’s disease—can also help patients with acute ischemic stroke improve functional outcomes by limiting brain inflammation in the post-stroke period.