Axovant Sciences has released positive interim results from its Phase II clinical trial for the company’s investigational Lewy body dementia drug, nelotanserin. So far, 11 patients have been treated with nelotanserin, and patients showed statistically significant improvements in extrapyramidal signs – such as tremor – compared to the placebo.
According to Axovant, these promising results have prompted the biopharma company to begin planning for a Phase III clinical trial. The company plans to start recruiting patients for this late-stage trial in the second half of 2017.
Nelotanserin is a selective inverse agonist of the 5HT2A receptor – a protein implicated in the motor symptoms and visual hallucinations experienced by individuals with Lewy body dementia. As such, the drug is being developed to address these neuropsychiatric disturbances and sleep problems common in patients with dementia.
The primary outcome of this trial was assessed using the Unified Parkinson’s Disease Rating Scale (UPDRS) Parts II + III. The Phase II study was also focused on assessing the safety of nelotanserin, with the study investigators writing that no serious drug-related adverse events were reported.
“I am intrigued by the benefits observed on the UPDRS in this study,” said 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. “If a single drug could simultaneously address the motor and neuropsychiatric symptoms of Lewy body dementia, which the published literature suggests may be the case for 5HT2A antagonists, it would represent a unique and important advance for the treatment of this condition. I look forward to reviewing the full dataset later this year.”
As Lewy body dementia is the second most common form of the disease next to Alzheimer’s, Axovant believes that there is a need for more therapeutics which address the Parkinsonism symptoms patients face. While full data for the Phase II trial is expected to be released in mid-2017, the company is already considering the trial a success as only half the target number of patients were enrolled in the study.
“We are pleased with the preliminary results of this small pilot study which supports our belief that nelotanserin could be a promising investigational drug candidate for patients suffering from Lewy body dementia,” said Dr. Lawrence Friedhoff, Chief Development Officer of Axovant Sciences. “We plan to discuss with FDA and other regulators the parameters of a potential Phase III registration program while we await results from the full cohort of patients in this study. We will carefully examine whether the UPDRS treatment benefit observed in this interim analysis will be maintained in the final analysis when the remaining patients complete this study.”