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Axovant Reports Results of Exploratory Phase 2 Clinical Study of Nelotanserin in Lewy Body Dementia Patients Experiencing REM Sleep Behavior Disorder | ||
By: Nasdaq / GlobeNewswire - 10 Dec 2018 | Back to overview list |
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BASEL, Switzerland, Dec. 10, 2018 (GLOBE NEWSWIRE) -- Axovant Sciences (NASDAQ: AXON) a clinical-stage gene therapy company, today reported topline results of the 34-patient, exploratory phase 2 clinical study of nelotanserin for the treatment of REM sleep behavior disorder (RBD) in patients with Lewy body dementia (LBD). The primary efficacy endpoint of reduction in frequency of RBD events as measured by sleep laboratory video assessment was not met. Nelotanserin was generally well-tolerated in the study. Signals of efficacy were observed on secondary measures, including trends in prespecified analyses of study diaries and certain sleep parameters on polysomnography (PSG). These findings are consistent with nelotanserin’s mechanism of action and previous clinical studies of nelotanserin in patients with insomnia. “While secondary measures of efficacy suggest biologic activity for nelotanserin, Axovant has been focused on developing innovative gene therapies and we will not undertake further clinical studies with our legacy small molecule portfolio, including nelotanserin,” said Pavan Cheruvu, M.D., chief executive officer of Axovant. “The completion of this study closes a chapter in the company’s history. We are grateful to the patients and clinical investigators who participated in this study, and we look forward to advancing Axovant’s gene therapy pipeline through multiple important milestones in 2019.” Axovant has been focused on gene therapies since the in-licensing of AXO-Lenti-PD in June 2018, and has since then strengthened its capabilities in the development, manufacturing and commercialization of gene therapies with the addition of experts to the team and continued expansion of its pipeline. AXO-Lenti-PD is an investigational gene therapy for Parkinson’s disease that delivers three genes in vivo via a lentiviral vector to encode the set of enzymes required for dopamine synthesis in the brain. The SUNRISE-PD phase 2 clinical study of AXO-Lenti-PD is ongoing, with data expected in March 2019. In addition, Axovant is developing AXO-AAV-OPMD, a gene therapy utilizing novel Silence-and-Replace technology to restore normal muscle function in patients with oculopharyngeal muscular dystrophy (OPMD), and plans to initiate a clinical study for the therapy in the second half of 2019. About the Nelotanserin REM Sleep Behavior Disorder Study About Axovant Sciences Forward-Looking Statements and Information Contacts: Investors |
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