Acadia Pharmaceuticals said on Thursday its experimental drug for psychosis associated with Alzheimer’s disease missed the main goal of a mid-stage study, sending the drugmaker’s shares down about 11 per cent.
Patients receiving a 60-milligram once-daily dose of remlifanserin showed greater improvement than those on placebo in reducing hallucinations and delusions, but the difference was not enough for the study to meet its main goal.
A lower 30-milligram dose showed little benefit across study measures, while the higher dose met a key secondary goal measuring the overall severity of Alzheimer’s disease psychosis symptoms.
Despite the setback, Acadia said it would continue enrolling patients in two ongoing late-stage studies and remove the 30-milligram treatment arm. It still expects remlifanserin to generate about US$4 billion in peak sales potential across Alzheimer’s disease psychosis and Lewy body dementia psychosis.
The company is also evaluating modest changes to patient selection criteria after analyzes suggested patients with more severe psychosis symptoms may derive greater benefit from the drug.
“I think it’s relatively unlikely that we’re going to do something that cuts into our trial eligible patient population too much more than that,” said Elizabeth H.Z. Thompson, Acadia’s research and development head, referring to potential refinements being considered for the late-stage program.
BMO Capital Markets analyst Evan Seigerman said the near miss on the study’s primary goal and positive result on a key secondary measure suggest a potential path forward for the program as Acadia modifies the design of its ongoing late-stage studies.
Acadia said rates of side effects, serious side effects and treatment discontinuations were similar to placebo, with no apparent adverse effects on movement or cognitive function and no deaths among treated patients.
Alzheimer’s disease psychosis affects about 30 per cent of people diagnosed with Alzheimer’s disease and can cause hallucinations and delusions, increasing caregiver burden and the need for nursing home care. There are currently no approved therapies specifically for the condition.
Reporting by Sahil Pandey in Bengaluru; Editing by Diti Pujara, Reuters
