Axovant to Present New Results on Intepirdine and Nelotanserin Research Programs

New results from its intepirdine (RVT-101) and nelotanserin research programs on Alzheimer’s disease (AD) and Lewy body dementia will be shared soon, Axovant Sciences announced.

The data will be presented at the 2017 Alzheimer’s Association International Conference (AAIC) in London  July 16-20.

Intepirdine is a selective antagonist of the 5HT6 receptor. This effect leads to the release of acetylcholine, an essential neurotransmitter that plays a key role in cognition, and whose levels are decreased in dementia.

Intepirdine is orally administered and provided in combination with Aricept (donepezil), a drug approved by the U.S. Food and Drug Administration to prevent the degradation of acetylcholine by the enzyme cholinesterase. By increasing the concentration of acetylcholine this combination therapy aims to improve the cognition and function of patients with mild-to-moderate AD.

The drug is undergoing the Phase 3 international MINDSET study (NCT02585934), which evaluates its safety, tolerability, and effectiveness in patients with mild-to-moderate AD. Intepirdine also is undergoing the Phase 2b study HEADWAY-DLB (NCT02669433), to evaluate its safety, tolerability, and effectiveness in patients with dementia with Lewy bodies.

In addition, the effect of intepirdine on gait and balance in patients with dementia is under evaluation in a Phase 2 trial. The study aims to further explore the previously observed reduced rate of falls in patients treated with intepirdine in a study enrolling 684 patients who have a background of stable Aricept treatment.

Nelotanserin is a potent and selective inverse agonist (a compound that binds to the same receptor as the agonist, but induces opposite effects) of the 5HT2A receptor, thereby reducing its activity. The 5HT2A receptor has been associated with neuropsychiatric disturbances, including visual hallucinations. The drug is being developed as once-daily, orally-administered potential treatment for Lewy body dementia. Nelotanserin was well-tolerated in seven clinical studies including nearly 800 people.

“This is an exciting time for Axovant and we are pleased to share such a breadth of data relating to our two, late-stage compounds,” David Hung, MD, CEO of Axovant, said in a press release. “We are committed to advancing the research of and treatment for AD and Lewy body dementia, as well as other debilitating neurologic diseases for which new treatments are desperately needed,” Hung said.