Date: 2014-12-23
Type of information: Product acquisition
Compound: SB742457
Company: GSK (UK) Roivant Neurosciences (Bermuda)
Therapeutic area: Neurodegenerative diseases
Type agreement: product acquisition
Action mechanism: SB742457 is a novel and potent 5-HT6 receptor antagonist that is being developed as an oral treatment for subjects with mild-to-moderate Alzheimer\'s disease. SB742457 improves cognition in preclinical models, and preliminary preclinical data suggest 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. Four Phase II studies of SB742457 in subjects with mild to moderate Alzheimer\'s disease have been completed, including three monotherapy studies and one adjunctive therapy study in patients already taking an acetylcholinesterase inhibitor, Aricept® (donepezil hydrochloride). SB742457 was generally safe and well-tolerated in all Phase II studies. The results of these studies provide strong evidence that SB742457 holds promise for patients with mild-to-moderate Alzheimer\'s disease.
Disease: Alzheimer\'s disease
Details: * On December 23, 2014, Roivant Neurosciences, a biopharmaceutical company dedicated to the development and commercialization of late-stage drug candidates for neurologic diseases, has entered into an agreement with 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. GSK conducted thirteen clinical studies of SB742457 involving over 1,250 healthy subjects and Alzheimer\'s disease patients. The results of these studies provide strong evidence that SB742457 holds promise for patients with mild-to-moderate Alzheimer\'s disease. Roivant intends to meet with the FDA in the first half of 2015 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. Roivant may also explore the clinical development of SB742457 for other neurological disorders for which there are limited or no therapeutic options.
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