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Biogen hands out $120m upfront for Remedy stroke drug

Cirara vying to be first new treatment since the 1990s

Biogen has added to its late-stage pipeline with a licensing deal for Remedy Pharmaceuticals' Cirara, a drug candidate en route to phase III testing for ischaemic stroke.

The US biotech major is paying $120m upfront for rights to the drug, which is vying to be the first new treatment for ischaemic stroke since alteplase - still the only approved treatment - which was given the green light by regulators in the 1990s. Additional milestone payments may be forthcoming but have not been disclosed.

The agreement is the latest in a new round of deal-making at Biogen that it says is needed to build up its pipeline in the face of competition for its multiple sclerosis treatments. Last month, the biotech kicked off the round with a $300m upfront deal with Bristol-Myers Squibb for experimental Alzheimer's drug, its largest deal for 10 years.

Cirara (RP-1127) is an intravenous formulation of glyburide, a drug better known for its longstanding use as an oral treatment for type 2 diabetes. Remedy is seeking to repurpose the drug as a stroke treatment, focusing initially on large hemispheric infarction (LHI), a particularly catastrophic stroke event that is often followed by swelling (oedema) in the brain with fluids flooding across the blood brain barrier.

The hypothesis is that glyburide can help prevent this oedema by blocking a specific channel - known as Sur1-Trpm4 - that increases in the wake of an LHI and seems to play a role in the mechanism behind the fluid build-up. Specifically, the channels open when the energy molecule of the cell ATP is depleted - as occurs when the blood supply is restricted in a stroke - allowing sodium ions to enter the cell, accompanied by water. Closing them down with glyburide is thought to prevent that process.

Remedy has already tested this in practice, with a phase II trial (GAMES-RP) in LHI showing a 25% reduction in neurological death with glyburide and a 7% reduction with placebo, which was a significant difference. Remedy's drug also reduced death from oedema by 22% versus 2% with placebo, and there was a three-fold reduction in overall mortality.

The drug missed its primary endpoint however, which was its ability to reduce the need for a surgical intervention called decompressive craniectomy that is used to relieve pressure on the brain. Undeterred, Remedy sought a meeting with the FDA that not only gave the go-ahead for the start of the firm's phase III CHARM trial, but has also granted orphan status and a fast-track review to the programme.

Biogen can see the potential, given that there are around 1.7m ischaemic strokes in the US, Europe and Japan each year, and approximately 15% of these come under the LHI category. And with its own portfolio of central nervous system drugs, Biogen has the resources in place to move ahead quickly with the phase III trial, which according to Remedy's website is due to start recruitment later this year.

"Cirara represents a potential breakthrough stroke treatment that accelerates our efforts to build a portfolio of new therapies for neurologic diseases," said Michael Ehlers, Biogen's executive vice president for R&D.

"We believe the data supporting the potential of Cirara are compelling and that [it] 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."

Article by
Phil Taylor

16th May 2017

From: Research



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