Eli Lilly has dropped its phase 2 Alzheimer's disease program for mevidalen, marking another setback for the experimental drug as the Big Pharma expands its neuroscience pipeline through multibillion-dollar acquisitions.
Lilly disclosed the decision Thursday as part of its third-quarter earnings update, listing mevidalen (LY3154207) among the assets “removed from the pipeline.”
The program in symptomatic Alzheimer's disease “did not meet our high internal bar for success,” a Lilly spokesperson told Fierce Biotech when asked about the decision. Lilly has not disclosed detailed results from the Alzheimer's trial or clarified whether the decision affects mevidalen's development in other indications.
The program cut comes nearly six months after Lilly completed a phase 2 trial evaluating mevidalen in 304 patients with mild-to-moderate Alzheimer's disease dementia. The study, which began in August 2024, was designed to assess the drug's safety and its effects on cognition, daily activities and other symptoms.
Mevidalen is a dopamine D1 receptor positive allosteric modulator designed to enhance signaling through a receptor involved in cognitive and motor function.
The Alzheimer's program was not the drug's first clinical setback. In 2021, Lilly reported that mevidalen failed to meet primary and secondary cognitive endpoints in a separate phase 2 trial involving patients with Lewy body dementia.
The decision comes amid a significant expansion of Lilly's neuroscience business, with the company spending billions of dollars this year to bolster its portfolio across sleep disorders, mental health and other neurological conditions.
In June, Lilly completed its $6.3 billion upfront acquisition of Centessa Pharmaceuticals, adding a pipeline of orexin receptor 2 agonists for narcolepsy and other sleep-wake disorders.
The following month, Lilly announced a $2.8 billion upfront deal to acquire AtaiBeckley, moving further into mental health treatments with a pipeline of psychedelic-inspired therapies. The acquisition closed in September, giving Lilly a potential challenger to Johnson & Johnson in treatment-resistant depression.
Lilly has also pursued partnerships to expand its neuroscience capabilities, including a collaboration with Canadian biotech QurCan Therapeutics focused on delivering genetic medicines to the central and peripheral nervous systems. QurCan is eligible for up to $237 million in milestone payments per program.
Those investments complement Lilly's existing neuroscience portfolio, which includes the approved Alzheimer's disease drug Kisunla and an investigational GBA1 gene therapy for Parkinson's disease.