-Roivant intends to commence Phase 3 clinical trials in Alzheimer's disease in 2015-
-Development led by the developer of Alzheimer's medicine, Aricept-
HAMILTON, Bermuda, Dec. 23, 2014 (GLOBE NEWSWIRE) -- Roivant Neurosciences Ltd. ("Roivant"), a biopharmaceutical company dedicated to the development and commercialization of late-stage drug candidates for neurologic diseases, has entered into 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. 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.
"This transaction represents a foundational late-stage clinical asset for Roivant," stated Vivek Ramaswamy, Founder and Director of Roivant Sciences Ltd. and CEO of Roivant Sciences, Inc. "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 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.
"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," stated Dr. Lawrence Friedhoff, Senior Vice President, Research & Development of Roivant Sciences, Inc. and the development team leader for Aricept® (donepezil hydrochloride), the drug most commonly used for the treatment of Alzheimer's disease. "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."
About Alzheimer's disease
Alzheimer's disease is a progressive, neurodegenerative disorder characterized by problems with memory, thinking and behavior that eventually become severe enough to affect daily tasks. An estimated 5.2 million people in the United States are currently living with Alzheimer's disease. Alzheimer's disease is the fifth leading cause of death in the United States among those aged 65 and older, and was reported as an underlying cause of death for more than 83,000 Americans in 2010. The cost of caring for patients with Alzheimer's disease places a significant burden on health services.
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.
Aricept® is a trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd.
Roivant Neurosciences Ltd. is a wholly-owned subsidiary of Roivant Sciences Ltd., a biopharmaceutical firm focused on the late-stage clinical development and commercialization of nonstrategic, deprioritized or under-resourced drug candidates. Backed by a global multi-strategy investment firm and an international specialty pharmaceutical company, Roivant Sciences uses its capital and in-house drug development expertise to move programs forward across a variety of pharmaceutical indications.
Roivant Sciences selectively evaluates regional or global opportunities across all therapeutic areas, mechanisms of action and routes of administration, with a special emphasis on areas of high unmet medical need, including rare diseases. Roivant will consider all levels of innovativeness while seeking to identify drug candidates whose potential may be underappreciated.
Additional information about Roivant is available at www.roivant.com.
Forward Looking Statements
This press release includes forward-looking statements. Because such statements deal with future events, they are subject to various risks and uncertainties and actual results could differ materially from Roivant's current expectations. Forward-looking statements are identified by words such as "anticipates," "projects," "expects," "plans," "intends," "believes," "may," "estimates," "targets," "hopes," and other similar expressions that indicate trends and future events.
Factors that could cause Roivant's results to differ materially from those expressed in forward-looking statements include, without limitation, delays in receiving regulatory guidance for the development of SB742457, uncertainties inherent in the initiation of future clinical trials, availability of data from previous clinical trials, satisfactory quantities of clinical drug product, availability of patients who meet the clinical trial enrollment criteria, availability of sufficient funding for foreseeable and unforeseeable operating expenses and capital expenditure requirements, and other matters that could affect the availability or commercial potential of SB742457. Roivant undertakes no obligation to revise or update forward-looking statements as a result of new information, since these statements may no longer be accurate or timely.
Alan S. Roemer SVP, Finance & Operations Roivant Sciences, Inc. +1 (212) 531-3315