Axovant's nelotanserin demonstrates treatment benefit in phase 2 dementia study
Axovant Sciences said its drug nelotanserin has passed an early hurdle in a phase 2 study for Lewy body dementia, encouraging it to start preparing for a phase 3 study.
The company is also making preparations for a phase III registration program that is expected begin in the second half of this year.
The double-blind, randomized, placebo-controlled and cross-over design phase II study included patients with either dementia with Lewy bodies (DLB) or Parkinson's disease dementia (PDD) who experience frequent visual hallucinations with a score of 18 or higher on mini mental state examination (MMSE).
Currently, the firm has reported preliminary results from the planned interim analysis of the first 11 patients in the study.
The study’s primary outcome measures were extrapyramidal signs as evaluated by Unified Parkinson's Disease Rating Scale (UPDRS) Parts II + III and safety.
The interim results include mean change from baseline in the UPDRS Parts II + III showed statistically significant improvements from nelotanserin relative to placebo.
According to the company, the result is consistent across least squares and observed mean changes.
The secondary endpoints assessed efficacy on multiple subscales from the SAPS, comprising of SAPS-PD, SAPS-PD-H, and SAPS-H.
Axovant assessed an internally developed and proprietary secondary endpoint to evaluate episodes of hallucinations using a patient diary.
These secondary endpoints have showed no statistically significant differences for nelotanserin relative to placebo in this interim analysis.
Axovant chief development officer Lawrence Friedhoff said: "We plan to discuss with FDA and other regulators the parameters of a potential Phase 3 registration program while we await results from the full cohort of patients in this study.”