Biogen buys Remedy’s phase 3 stroke drug for $120M

Just in case you want to fund your own trials of this drug. No clue which piece in the neuronal cascade of death this is targeting. Impossible to tell what strategy Biogen is following, but I bet this is 'flailing in the dark' and hope to get lucky. 

Biogen buys Remedy’s phase 3 stroke drug for $120M 

Biogen has paid $120 million upfront for Remedy Pharmaceuticals’ phase 3 stroke asset Cirara. The deal sees Biogen add a late-phase treatment for large hemispheric infarction (LHI) to its pipeline in return for the upfront fee and undisclosed milestones and royalties.
New York City-based Remedy will continue to contribute to the cost of developing Cirara in LHI, a form of ischemic stroke characterised by swelling of the brain. This swelling, also known as cerebral edema, arises when cellular dysfunction poststroke allows fluids to cross the blood brain barrier. The swelling caused by this process contributes to poor outcomes in stroke patients, making the pathway that underpins it a target of interest for drug developers.
Remedy’s answer to the problem is glyburide, a decades old antidiabetic drug that inhibits ATP-sensitive potassium channels and the sulfonylurea receptor 1 (SUR1). The bet on glyburide is underpinned by a belief it can prevent the development of edemas by blocking SUR1-transient receptor potential melastatin-4 (TRPM4), nonselective cation channels that are upregulated after ischemia.
That belief in glyburide has been tested by clinical data. A phase 2 trial of Cirara missed its primary endpoint after the drug failed to reduce incidence of decompressive craniectomy. But having come through an end-of-phase 2 meeting with the FDA last year, Remedy decided to push ahead into a late-stage trial. And in Biogen it has found a company that shares its confidence in the data, or is at least willing to put down $120 million to learn whether it can crack a major underserved market.
“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,” Biogen EVP Michael Ehlers, M.D., Ph.D. said in a statement.
Ehlers framed the deal as adding to Biogen’s neuroscience activities and, more specifically, fleshing out its pitch to corner the the market for treatments for acute ischemic stroke. The candidate slots into Biogen’s pipeline just ahead of natalizumab, a monoclonal antibody the Big Biotech is testing in a phase 2b study.

Innovative treatment may help prevent brain swelling, death in stroke patients

See what your hospital is doing about this. 

Innovative treatment may help prevent brain swelling, death in stroke patients

New research has provided more evidence that an innovative treatment strategy may help prevent brain swelling and death in stroke patients. J. Marc Simard, professor of neurosurgery at the University of Maryland School of Medicine, along with colleagues at Yale University and Massachusetts General Hospital, found that Cirara, an investigational drug, powerfully reduced brain swelling and death in patients who had suffered a type of large stroke called malignant infarction, which normally carries a high mortality rate.
The findings were presented at the International Stroke Conference, held last month in Los Angeles.
"These results are quite promising," says Dr. Simard. "We have a lot more work to do, but this approach could be an effective strategy for severe stroke patients who currently have no good treatment options."
In October 2015, Dr. Simard and his colleagues, Kevin N. Sheth, of Yale, and W. Taylor Kimberly, of Massachusetts General Hospital, presented early data at the Neurocritical Care Society annual meeting, showing that the medication was effective in reducing brain swelling.

• Daylight saving time can increase stroke risk, study reveals

In stroke patients who were aged 70 or younger, the researchers found that six months after the stroke, the group of patients who had been given Cirara had a three-fold reduction in overall mortality and a ten-fold decrease in death from brain swelling.
Swelling is a key complication in many central nervous system ailments, including stroke, traumatic brain and spinal cord injuries, and others. In all of these conditions, tiny blood vessels react to injury in a way that ultimately can be counterproductive, often leading to severe swelling of brain tissues that can be fatal. Dr. Simard and his colleagues discovered that in many of these conditions, the sulfonylurea receptor 1 (Sur1) plays a major, previously unrecognized, pathological role. It appears that Sur1 is involved in many of the most dangerous symptoms in these diseases, including cell swelling, cell death, and the breakdown of the barrier that normally protects the brain and inflammation.
The researchers have focused primarily on a drug called glibenclamide (also known as Glyburide), which inhibits Sur1. Glibenclamide is a well-known, safe drug that has been in use for nearly 50 years to treat adult onset diabetes.
Cirara, which is made by Remedy Pharmaceuticals, which is based in New York City, is an exclusive intravenous formulation of glibenclamide.
"This new data shows a continued reduction in mortality and improvement in functional scores," Sven Jacobson, CEO of Remedy Pharmaceuticals. "The data further confirms the mechanism of action of Cirara."
The researchers and Remedy are now planning to undertake a Phase 3 trial. The drug will be given to a larger group of people to confirm its effectiveness and compare it to commonly used stroke treatments.

Source:

University of Maryland School of Medicine