Axovant Sciences Ltd., a clinical-stage biopharmaceutical company addressing the cognitive, behavioral, and functional components of dementia, recently announced that two presentations on the company’s drug development efforts have been accepted for the 2015 International Conference of the Alzheimer’s Association (AAIC) that will take place in Washington, D.C. from the 18th until the 23rd of July, 2015.
The presentations are titled: “Efficacy of RVT-101 in Mild-Moderate Alzheimer’s Disease: Completer Analysis (Oral Presentation)” and “The Efficacy of RVT-101, a 5-HT6 Receptor Antagonist, As an Adjunct to Donepezil in Adults with Mild-to-Moderate Alzheimer’s Disease: Completer Analysis of a Phase 2b Study,” both of which will be presented during the “Developing Topics Session: Clinical Trial Results” on Wednesday, July 22, 2015.
Alzheimer’s disease is a progressive neurodegenerative disorder. According to the Alzheimer’s Association, a leading voluntary health organization in Alzheimer’s disease care, support and research, Alzheimer’s disease affects approximately 5.3 million people in the United States. It is estimated that between 70% and 90% of Alzheimer’s disease patients aged 65 and older are classified as having mild-to-moderate Alzheimer’s disease.
No new chemical entity has been approved by the U.S. Food and Drug Administration for the treatment of Alzheimer’s disease since 2003, with multiple drugs aimed at modifying the course of the disease having failed at various stages of development.
Key opinion leaders in Alzheimer’s disease research have called into question the field’s historical focus on developing “disease-modifying” drugs, and more generally, the distinction between “disease-modifying” and “symptomatic” therapies for Alzheimer’s disease. RVT-101 is a potent, orally administered antagonist of the 5-hydroxytryptamine 6, or 5-HT6, serotonin receptors in the brain. Antagonism of the 5-HT6 receptor is a novel mechanism of action that promotes the release of acetylcholine, glutamate and other neurotransmitters. These neurotransmitters are believed to be critical for alertness, memory, thought and judgment, key components of cognition and function that are impaired in patients with Alzheimer’s disease.
The company plans to develop RVT-101 for use in combination with donepezil and potentially other cholinesterase inhibitors. Donepezil, is one of the most commonly used cholinesterase inhibitors. Cholinesterase inhibitors are designed to help prevent the breakdown of acetylcholine.
Cholinesterase inhibitors are the current standard of care for the treatment of mild-to-moderate Alzheimer’s disease, and the only class of drugs approved by the FDA for the treatment of patients with mild Alzheimer’s disease. Based on preclinical and clinical data collected to date, the company believed that RVT-101, when used in combination with donepezil, works additively to increase the concentration of acetylcholine and other neurotransmitters and thereby synergistically improve cognition and function in patients with Alzheimer’s disease.