Shares of Axovant Sciences Ltd. (AXON) are up an impressive 76% year-to-date compared to a modest 9.41% rise in the iShares NASDAQ Biotech Index ETF (IBB) during the same period.
Axovant is a clinical stage company focused on the treatment of dementia by broadly addressing multiple forms of the condition.
The Company’s most advanced drug candidate in the pipeline is Intepirdine, an oral, selective 5-HT6 receptor antagonist that works by promoting the release of acetylcholine within the brain. Acetylcholine is known to improve learning and memory.
A phase III trial of Intepirdine in patients with mild-to-moderate Alzheimer’s disease, dubbed MINDSET, is underway.
The 24-week MINDSET trial compares 35 mg, once-daily oral dose of Intepirdine to placebo in approximately 1,315 patients on a stable background of Donepezil. (Donepezil (Aricept) is an approved drug to treat mild to moderate dementia caused by Alzheimer’s disease.
Top line results from the MINDSET trial are expected in late September of this year.
The potential of Intepirdine is also being explored in Lewy body dementia patients, and a phase II trial in this indication is ongoing. The study is known as HEADWAY-DLB, and is designed to enroll 240 patients.
The results from the HEADWAY-DLB trial are expected in the fourth quarter of this year.
Another phase II study evaluating the effect of Intepirdine on gait and balance in patients with Alzheimer’s disease, Dementia with Lewy Bodies or Parkinson’s disease Dementia is also ongoing. This study is designed to enroll 40 patients, and results are anticipated this year.
Also in the pipeline are:
— Nelotanserin, a selective inverse agonist of 5HT2A receptor. The 5HT2A receptor has been linked in neuropsychiatric disturbances including visual hallucinations – a common occurrence in people living with Lewy body dementia.
A phase II trial of Nelotanserin for the treatment of visual hallucinations in subjects with Lewy body dementia, and a phase II trial of Nelotanserin for the treatment of Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with dementia with Lewy bodies (DLB) or Parkinson’s disease dementia (PDD) are ongoing.
The results from the two phase II trials of Nelotanserin are expected to be available in the second half of 2017.
— RVT-103, a combination of Donepezil and a peripheral muscarinic receptor antagonist, which is under proof of concept study for Alzheimer’s disease. Results from the proof of concept study are expected within the next three months.
— RVT -104, a combination of rivastigmine and a peripheral muscarinic receptor antagonist. Preparations for a proof of concept study with RVT -104 in patients with Alzheimer’s disease and Dementia with Lewy Bodies are underway.
On April 10th, the Company announced the appointment of David Hung as its Chief Executive Officer, effective April 7, 2017.
Hung was the co-founder, President, and Chief Executive Officer of Medivation, which was acquired by Pfizer for…