New Preclinical Data for Intepirdine Suggests Potential Neuroprotective Properties
"Dementia of the Alzheimer's type represents one of the most complex and important unmet needs in all of medicine," said David Hung, M.D., chief executive officer of Axovant. "The neuroprotective properties observed in this preclinical study of intepirdine are intriguing. We look forward to further exploring this hypothesis."
In the animal model used in this study, intepirdine demonstrated neuroprotective effects under hypoxic and hypoglycemic conditions in an in vitro assay of mixed cortical neuron (MCN) cultures at clinically relevant concentrations. Specifically, when pre-treated with intepirdine for 24 hours, a decrease in lactate dehydrogenase (LDH) release, a surrogate marker of cell death, was observed in MCN cultures exposed to oxygen and glucose deprivation (p<0.05 at multiple intepirdine concentrations).
Intepirdine is a potent 5HT6 receptor antagonist in development for the potential treatment of mild to moderate Alzheimer's disease and Lewy body dementia. Intepirdine works in part by promoting the release of acetylcholine, a neurotransmitter critical to cognition and function in patients with Alzheimer's disease. Axovant is evaluating intepirdine in MINDSET, a global, multi-center, double-blind, placebo-controlled Phase 3 study in subjects with mild to moderate Alzheimer's disease who are on stable background donepezil therapy, and expects to report topline results from this study in late
Axovant is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative medicines to broadly address multiple forms of dementia and related neurological disorders. Axovant is developing a pipeline of late- and early-stage product candidates that focuses on the cognitive, functional, and behavioral aspects of debilitating conditions such as Alzheimer's disease, Lewy body dementia and other neurological disorders. For more information, visit www.axovant.com.
This press release contains forward-looking statements, including statements regarding Axovant's expectations about timing of the results for the Phase 3 MINDSET study of intepirdine in subjects with Alzheimer's disease, the Phase 2b HEADWAY-DLB study of intepirdine in subjects with DLB, the Phase 2 gait and balance study, the proof of concept and related studies of RVT-103 and RVT-104, other potential pre-clinical and clinical studies regarding intepirdine and other elements of its clinical development and regulatory strategy.
Forward-looking statements can be identified by the words "believe," "anticipate," "continue", "estimate", "project," "expect," "plan," "potential," "intends," "will," "would", "could", "should" or the negative or plural of these words or other similar expressions that are predictions or indicate future events, trends or prospects. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with the success, cost and timing of our product development activities and clinical trials; the approval and commercialization of our product candidates intepirdine, nelotanserin, RVT-103, and RVT-104; and increased regulatory requirements. These statements are subject to the risk that clinical trial data are subject to differing interpretations, and regulatory agencies, medical and scientific experts and others may not share Axovant's views of the clinical study data. There can be no assurance that the clinical programs for intepirdine, nelotanserin, RVT-103, or RVT-104 will be successful in demonstrating safety and/or efficacy, that we will not encounter problems or delays in clinical development, or that any of our product candidates will ever receive regulatory approval or be successfully commercialized.
For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Axovant's business in general, see the "Risk Factors" section of our annual report on Form 10-K filed with the
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