Axovant launches nelotanserin and 3 new clinical programs to treat Lewy body dementia. Also, their drug RVT-101 for Dementia with Lewy Bodies and Alzheimer’s gets the green light. Get the details on these cutting-edge dementia trials.
HAMILTON, Bermuda, /PRNewswire/ — Axovant Sciences Ltd. (NYSE: AXON), a leading clinical-stage biopharmaceutical company focused on the treatment of dementia, announced an expansion of its dementia drug development pipeline with the acquisition of nelotanserin and the addition of three new clinical programs to address cognitive, behavioral and functional aspects of Lewy body dementia, a disease affecting approximately 1.4 million people in the U.S. The Company also provided an update on its ongoing Phase 3 development program for RVT-101 to treat Alzheimer’s disease.
Nelotanserin and RVT-101
“Consistent with our mission, we have expanded our development pipeline in a capital-efficient manner that we believe will enable Axovant to create value for patients and our shareholders,” stated Vivek Ramaswamy, Chief Executive Officer of Axovant Sciences, Inc. “The acquisition of global rights to nelotanserin and the addition of a development program for RVT-101 in dementia with Lewy bodies should lead to multiple value-creating catalysts in 2016 and help establish Axovant as the global leader in the treatment of Lewy body dementia.”
Lewy Body Dementia Association Sounds Off
Dr. James Leverenz, Chair, Scientific Advisory Council of the Lewy Body Dementia Association and Director of the Cleveland Lou Ruvo Center for Brain Health at the Cleveland Clinic, stated, “Pharmaceutical companies have historically neglected Lewy body dementia despite its status as the second leading degenerative cause of dementia, next to Alzheimer’s disease. The new development programs for RVT-101 and nelotanserin represent an important and promising step towards addressing this devastating disease, and I look forward to the progress of these exciting innovations in the field.”
Nelotanserin Launching New Clinical Trials
In October 2015, Axovant exercised its option to acquire global rights to nelotanserin from its parent company, Roivant Sciences Ltd. (RSL). RSL had previously acquired the global rights from Arena Pharmaceuticals, GmbH (Arena).
Axovant intends to initiate two Phase 2 clinical studies with nelotanserin in the first quarter of 2016. The first study will be in patients with either dementia with Lewy bodies (DLB) or Parkinson’s disease dementia (PDD) who suffer from visual hallucinations. The second study will be in DLB patients experiencing REM Behavior Disorder (RBD).
Axovant also intends, pending additional data available in 2016, to initiate programs for nelotanserin in Alzheimer’s disease psychosis and Parkinson’s disease psychosis.
Dominic Behan, Ph.D., D.Sc., Chief Scientific Officer and Co-Founder of Arena, commented, “We are excited to work with Axovant to bring this potentially best-in-class 5HT2A inverse agonist to market. We chose Axovant’s team based on their clear leadership in the field of dementia. The impressive development plans that Dr. Larry Friedhoff and his team have created reaffirms our belief that working with Axovant will give nelotanserin the best opportunity to reach dementia patients.”
RVT-101 in Dementia with Lewy Bodies Also Gets Green Light
Axovant plans to initiate a 24-week Phase 2b study of RVT-101 as a potential treatment for DLB. The study is expected to start in the first quarter of 2016. If the results of this study are favorable, Axovant believes that the study could serve as the basis for seeking approval of RVT-101 to treat DLB patients.
FDA Approves Special Assessment for RVT-101 in Alzheimer’s
As announced previously, in October 2015 Axovant commenced a global, multi-center, double-blind, placebo-controlled confirmatory Phase 3 study of RVT-101 for the treatment of mild-to-moderate Alzheimer’s disease called the MINDSET Study.
The MINDSET Study is evaluating the safety, tolerability and efficacy of RVT-101 and seeks to confirm the results of a prior study in which patients treated with RVT-101 were observed to have statistically significant improvements in cognition and function in mild-to-moderate Alzheimer’s disease patients. Subjects completing the MINDSET Study will be eligible to enroll in a 12 month open-label extension trial in which other medications for the treatment of Alzheimer’s disease, including memantine and other cholinesterase inhibitors may be administered in combination with RVT-101.
Axovant has received a Special Protocol Assessment (SPA) agreement from the FDA for the MINDSET Study. The SPA agreement states that the design and planned analysis of this study adequately address the objectives necessary to support an application for marketing approval.
Axovant Sciences Ltd. is a leading clinical-stage biopharmaceutical company focused on acquiring, developing and commercializing novel therapeutics for the treatment of dementia. Axovant intends to develop a pipeline of product candidates to comprehensively address the cognitive, functional and behavioral components of dementia and related neurological disorders. Our vision is to become the leading company focused on the treatment of dementia by addressing all forms and aspects of the disease.
RVT-101 is an orally administered, potent antagonist of the 5HT6 receptor. Antagonism of the 5HT6 receptor is a novel mechanism of action that promotes the release of acetylcholine and other neurotransmitters thought to improve cognition and function in patients suffering from Alzheimer’s disease and other forms of dementia. RVT-101 has been studied in 13 clinical trials and dosed in over 1,250 human subjects with a favorable safety and tolerability profile.
RVT-101 is an investigational new drug candidate and is not approved for any indication in any markets.
MINDSET is a Phase 3 international, multi-center, double-blind, placebo-controlled clinical study designed to evaluate the safety, tolerability and efficacy of RVT-101 in patients with mild-to-moderate Alzheimer’s disease. The 24-week trial will compare 35-mg, once-daily oral doses of RVT-101 to placebo in approximately 1,150 patients with mild-to-moderate Alzheimer’s disease on a stable background of donepezil therapy. The primary efficacy evaluations are the Alzheimer’s Disease Assessment Scale – cognitive subscale (ADAS-cog) and the Alzheimer’s Disease Cooperative Study – Activities of Daily Living scale (ADCS-ADL), each of which have been used as endpoints to obtain regulatory approval of currently-marketed Alzheimer’s disease treatments in the United States and Europe.
The MINDSET trial is designed to confirm the results of a 684-patient Phase 2 international, multi-center, double-blind placebo-controlled study in which patients on a stable background of donepezil therapy receiving 35 mg of RVT-101 were observed to have statistically significant improvements in their ADAS-cog and ADCS-ADL scores as compared to patients receiving donepezil alone.
Nelotanserin is a potentially best-in-class, once-daily orally-administered, highly potent and selective inverse agonist of the 5HT2A receptor, which has been implicated in the pathophysiology of neuropsychiatric disturbances including psychosis and visual hallucinations. Axovant intends to develop nelotanserin to address multiple aspects of Lewy body dementia. Nelotanserin has been studied in seven clinical studies completed to date with nearly 800 human subjects exposed to the drug candidate. Nelotanserin has been well-tolerated in all clinical studies to date.
Nelotanserin is an investigational new drug candidate and is not approved for any indication in any markets.
About Lewy Body Dementia
Lewy body dementia is a progressive neurodegenerative disorder, which is pathologically characterized by the aggregation of alpha synuclein and other proteins in the brain known as Lewy bodies, causing cognitive, functional and behavioral effects. Lewy body dementia includes two similar conditions; dementia with Lewy bodies, or DLB, and Parkinson’s disease dementia, or PDD. There are approximately 1.4 million people in the U.S. with Lewy body dementia.