Lilly Nixes Regulatory Submission of Alzheimer’s Drug

Eli Lilly and Company has said it will not pursue regulatory submissions for its biologic drug candidate, solanezumab, for treating mild dementia due to Alzheimer’s disease, following disappointing results of a Phase III clinical study where solanezumab did not meet the study’s primary endpoint.

Patients treated with solanezumab did not experience a statistically significant slowing in cognitive decline compared to patients treated with placebo, according to the company.

Lilly will work with investigators to appropriately conclude open-label extensions for three clinical studies, designated Expedition, Expedition2, and Expedition3. The company has not yet determined what its next next steps will be for the remaining elements of the solanezumab development program.

Solanezumab is Lilly’s Phase III monoclonal antibody being studied as a potential therapy for people with mild cognitive impairment due to Alzheimer’s disease, preclinical Alzheimer’s disease, and dominantly inherited Alzheimer’s disease.

Source: Eli Lilly and Company

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