Axovant Sciences said Monday that it will end development of intepirdine after the experimental 5-HT6 receptor antagonist failed to meet the main efficacy endpoint of a mid-stage study in patients with dementia with Lewy bodies. CEO David Hung, who joined Axovant in April last year, noted "based on the totality of intepirdine data to date, there is no evidence to support its further development." Shares in the company plunged as much as 46 percent on the news.
In the HEADWAY study, 269 patients with dementia with Lewy bodies were randomised to receive intepirdine, at a dose of 35 mg or 70 mg, or placebo for 24 weeks. The trial's primary efficacy endpoint was the change from baseline to week 24 in motor function as measured using the Unified Parkinson's Disease Rating Scale (UPDRS) Part III, while secondary goals were the change from baseline to week 24 in cognition as measured by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) and the change in baseline in global function as measured by the Clinician Interview-Based Impression of Change plus caregiver interview (CIBIC+).
Results showed that the lower dose of intepirdine was linked to a 2.01-point worsening of symptoms on the UPDRS Part III versus placebo, while the higher dose was associated with an improvement of 0.74 points. Axovant noted that neither dose resulted in significant improvements after 24 weeks of treatment compared with placebo. In addition, the two doses were linked to a 0.47-point worsening and a 0.67-point improvement, respectively, on the ADAS-Cog, as well as a 0.15-point improvement and 0.07-point improvement, respectively, on the CIBIC+.
In September, Axovant announced that a late-stage study of intepirdine in patients with mild-to-moderate Alzheimer's disease who were receiving background donepezil therapy failed to meet its co-primary efficacy endpoints. Axovant also disclosed on Monday that intepirdine failed to improve gait speed versus placebo in a Phase II study of patients with dementia and gait impairment.
Axovant's parent company Roivant Sciences gained rights to intepirdine from GlaxoSmithKline in 2014. Analysts had estimated that the therapy could achieve peak sales of $2 billion to $4 billion annually if approved.
Meanwhile, Axovant noted that the experimental therapy nelotanserin was associated with significant improvements on the UPDRS Part III versus placebo in a pilot Phase II study of patients with dementia with Lewy bodies, in addition to an efficacy signal in patients with higher baseline scores on the Scale for the Assessment of Positive Symptoms - Parkinson's Disease. Hung said the drugmaker plans to meet with the FDA to discuss a larger confirmatory study focused on patients with dementia with Lewy bodies with motor deficits and more severe baseline psychotic symptoms.
Nelotanserin is a selective inverse agonist of the 5-HT2A receptor that was discovered by Arena Pharmaceuticals. In 2015, Roivant gained exclusive worldwide rights to develop and commercialise nelotanserin.
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