Eli Lilly’s (NYSE:LLY) decision to alter the primary endpoint in an ongoing Phase III trial of solanezumab in Alzheimer’s disease (AD) has drawn expert debate on the rationale and expectations on trial outcomes.
All experts agreed the endpoint was changed to increase the chance of success on the now singular primary endpoint. Some experts argued this rationale indicates a flaw in trial design and could cast some doubt over the results’ clinical significance. Others argued that statistical significance on the cognitive primary endpoint, in conjunction with biomarker data supporting amyloid reduction, would constitute clinically meaningful data.
On 15 March the company announced it would be changing the primary endpoint of the Phase III EXPEDITION3 study (NCT01900665) to a single primary endpoint of cognition as measured by Alzheimer's Disease Assessment Scale-Cognitive 14 Item sub score (ADAS-Cog14). Eli Lilly’s share price fell 5% following the announcement.