Axovant To Discontinue Intepirdine Program After Negative Results In Studies

(RTTNews) - Axovant Sciences Ltd. (AXON) said that its investigational drug intepirdine did not meet its primary efficacy endpoints in the Phase 2b HEADWAY and pilot Phase 2 Gait and Balance studies. The company noted that the Intepirdine program will be discontinued based on the MINDSET, HEADWAY, and Gait and Balance study results.

Separately, the company's investigational drug nelotanserin met its pre-specified primary endpoint of safety in the pilot Phase 2 Visual Hallucination study.

In addition, in this exploratory study, nelotanserin treatment resulted in a positive trend in efficacy in a pre-specified intent to treat or ITT analysis of the motor function scale, the Unified Parkinson's Disease Rating Scale (UPDRS) Part III.

Nelotanserin treatment also resulted in an efficacy signal in a post-hoc subset analysis of patients with higher baseline scores on the Scale for the Assessment of Positive Symptoms - Parkinson's Disease or SAPS-PD.

Axovant Sciences noted that in the HEADWAY study of intepirdine in patients with dementia with Lewy bodies or DLB, neither 35 mg nor 70 mg of intepirdine resulted in statistically significant improvements after 24 weeks of treatment compared with placebo-treated patients.

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.

Previously defined co-primary endpoints for the HEADWAY study were the CIBIC+ and a computerized cognitive battery or CCB.

The company noted that Intepirdine did not achieve statistical significance on the CCB, with 35 mg of intepirdine resulting in a composite z-score of a 0.38 worsening versus placebo and 70 mg of intepirdine resulting in a composite z-score of a 0.36 improvement versus placebo.

Axovant said it will work with investigators to appropriately conclude the HEADWAY and MINDSET extension studies.