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news.Roivant Neurosciences has signed an agreement with GlaxoSmithKline (GSK) for the acquisition of SB742457, a selective 5-HT6 receptor antagonist with the potential to improve cognition and function in multiple central nervous system disorders.
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SB742457 has shown promise for patients with mild-to-moderate Alzheimer’s disease in 13 clinical studies conducted to date by GSK using more than 1,250 healthy subjects and Alzheimer’s disease patients.
Roivant Sciences founder, director and chief executive officer Vivek Ramaswamy said: "This transaction represents a foundational late-stage clinical asset for Roivant.
"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."
Roivant Sciences Research & Development senior vice president and Aricept development team leader Dr Lawrence Friedhoff said: "Despite the large number of clinical trials in Alzheimer’s disease and related disorders during the past decade, there have been no new drugs approved in that period.
"As we advance SB742457 into Phase 3 pivotal studies in 2015, we hope and expect that these clinical trials will support the approval of a new therapeutic option for patients."
In the first half of 2015, Roivant plans to meet with the US Food and Drug Administration (FDA) to confirm the regulatory requirements for the continued development of SB742457 for the treatment of the signs and symptoms of mild-to-moderate Alzheimer’s disease.
In addition, the company may explore the clinical development of SB742457 for other neurological disorders for which there are limited or no therapeutic options.
SB742457 improves cognition in preclinical models, and is claimed to exert a potential additive or synergistic effect when 5-HT6 antagonists are added to acetylcholinesterase inhibitors, one of the two classes of drugs approved by the FDA for the treatment of Alzheimer’s disease.
Alzheimer’s disease is a progressive, neurodegenerative disorder characterized by problems with memory, thinking and behaviour that eventually become severe enough to affect daily tasks.
Image: GSK has signed an agreement to sell SB742457 to Roivant Neurosciences. Photo: courtesy of Maxwell Hamilton.