Axovant Sciences Ltd. (NASDAQ: AXON) watched its shares practically get halved in Monday’s session after the firm provided an update from a few of its midstage clinical trials. While one of its Phase 2 Visual Hallucination studies with nelotanserin met its primary endpoint, the Phase 2b Headway and pilot Phase 2 Gate and Balance studies did not meet their primary endpoints.
On the positive side, the nelotanserin treatment resulted in a positive trend in efficacy in a prespecified intent to treat (ITT) analysis of the motor function scale, the Unified Parkinson’s Disease Rating Scale (UPDRS) Part III. However, the good news stopped here.
In the Headway study of intepirdine in patients with dementia with Lewy bodies (DLB), neither dose segment of intepirdine resulted in statistically significant improvements. In motor function, as measured by the UPDRS Part III, 35 mg of intepirdine caused a 2.01 point worsening versus placebo and 70 mg of intepirdine caused a 0.74 point improvement versus placebo. This was not exactly conclusive.
Separately, in cognition, as measured by the Alzheimer’s Disease Assessment Scale-Cognitive Subscale, 35 mg of intepirdine caused a 0.47 point worsening versus placebo and 70 mg of intepirdine caused a 0.67 point improvement versus placebo.
In the pilot study of nelotanserin in patients with DLB and Parkinson’s disease dementia who were experiencing visual hallucinations, the primary endpoint was safety, including an assessment of symptoms as measured by the UPDRS. Here’s what the firm had to say about these results:
Although nelotanserin did not significantly improve the Scale for the Assessment of Positive Symptoms (SAPS) in the entire efficacy evaluable population, in a post-hoc subset analysis of patients with a baseline SAPS-PD score greater than 8.0, indicating greater severity, nelotanserin treatment at 40 mg for two weeks followed by 80 mg for two weeks resulted in a 1.21 point improvement. Further analyses of these data will be conducted which could yield new insights into the effects of nelotanserin.
While there was some positive news in this update, the bad seemed to far outweigh the good and making headway was a more difficult than originally thought.
Shares of Axovant were down about 48% at $2.78 early Monday, with a consensus analyst price target of $13.17 and a 52-week range of $4.60 to $27.98.