NEW YORK, NY – October 22, 2019 – Embark Healthcare announced today that Biogen (Nasdaq:BIIB), an American multinational biotechnology company based in Cambridge, Massachusetts and specializing in the discovery, development, and delivery of therapies for the treatment of neurological diseases to patients worldwide, reported that it enrolled the first patient in a phase 2 brain contusion study using BIIB093.
In 2017, Embark portfolio company, Remedy Pharmaceuticals, sold its CIRARA drug development program (now called BIIB093) to Biogen for a $120 million upfront payment plus certain potential future milestone and royalty payments.
As Alfred Sandrock, Executive Vice President, Research & Development and Chief Medical Officer of Biogen stated in a call with analysts following release of his company’s earnings, “Approximately 280,000 patients are hospitalized due to head trauma annually in the United States. We estimate the contusions occur in approximately 25% to 35% of these patients. There are no pharmaceutical agents approved to mitigate contusion expansion, which is associated with worsened clinical outcomes.”
The trial this is a multicenter, double-blind, multidose, placebo-controlled, randomized parallel-group, 160-patient phase 2 study to evaluate the efficacy and safety of intravenous BIIB093 for patients with brain contusion
“The primary objective of this new study of BIIB093,” notes Sandrock, “will evaluate the proportion of patients with brain contusion, who exhibited an expansion in contusion volume over the course of a 96 hour infusion of BIIB093 versus placebo.”
In 2018, Biogen began a large Phase 3 study of BIIB093 for cerebral edema caused by large hemispheric infarction (LHI). According to Biogen, it is estimated that nearly two million people in the United States and the European Union will have a stroke each year. Stroke is a leading cause of mortality and serious long-term disability. There is a substantial unmet medical need for new therapies that can improve outcomes in acute stroke. LHI is a severe form of ischemic stroke where brain swelling (cerebral edema) that often leads to a disproportionately large share of stroke-related morbidity and mortality.
“Importantly,’ adds Sandrock, “We believe that the shared pathophysiologic features of LHI and brain contusion exemplify the interconnectivity of neuroscience that we are leveraging as we continue to increase the depth and breadth of our pipeline. This also highlights our strategy to pursue multiple indications for a given asset, particularly once we believe safety has been adequately established.“
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