Upstart biotech grabs Alzheimer's drug from GlaxoSmithKline, plots PhIII

An upstart biotech based in Bermuda says that it has in-licensed an Alzheimer's drug from GlaxoSmithKline ($GSK) and plans to take it into Phase III studies next year.

Roivant Neurosciences is a subsidiary of Roivant Sciences, which was set up by a former hedge fund partner named Vivek Ramaswamy, a graduate of Harvard and Yale who was recently named one of Forbes' 30 under 30. He's grabbed a 5-HT6 receptor antagonist from GlaxoSmithKline dubbed SB742457 which the company says has been tested in 1,250 Alzheimer's patients and healthy subjects.

While Alzheimer's has been in the spotlight for years in biopharma, this is one program that hasn't made headlines. According to clinicaltrials.gov, the drug finished 5 studies that GSK wrapped between 2008 and 2012. There was no word in Roivant's release on the deal terms.

Lundbeck and Otsuka have a 5-HT6 receptor antagonist in the clinic, Lu AE58054, which just began a Phase III program in October.

A few months ago investigators said they tracked a clear, statistically significant improvement in the combo arm of the Phase II study, which compared results for Lu AE58054/donepezil with a control arm that was provided donepezil and a placebo. The primary endpoint was ADAS-Cog at Week 24, which measures the severity of the most important symptoms. The drug failed to distinguish itself for secondary endpoints on two other measures.

"This transaction represents a foundational late-stage clinical asset for Roivant," said Ramaswamy in a statement. "Our organization is fully committed to building on the research already completed by GSK and advancing a new therapeutic option for Alzheimer's disease, a debilitating and deadly disease that affects millions of patients and their families."

Getting positive results from a Phase III Alzheimer's drug has been all but impossible over the past decade. The startup is following in the footsteps of some giant companies which have experienced a near 100% failure rate in late-stage studies. But any approval here would likely trigger a blockbuster franchise, making Alzheimer's the golden lottery ticket in biotech.

- here's the release

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