When Acadia trumpeted news that it would end a late-stage trial for its Nuplazid in dementia-related psychosis (DRP) early, it represented a big win for a drugmaker still stinging from a major schizophrenia flop. Now, data from that trial are giving some analysts hope that Nuplazid could hit blockbuster heights––with or without schizophrenia.
Nuplazid cut the risk of DRP relapse by 180% over placebo and reduced the rate of trial discontinuation by 120% over placebo, according to top-line data from the phase 3 Harmony study presented Wednesday at the Clinical Trials on Alzheimer's Disease (CTAD) meeting.
The promising top-line results followed Acadia's announcement in September that it had halted the Harmony study for Nuplazid after the drug hit its interim primary endpoint. The San Diego-based company said it plans to file for an FDA approval in 2020.
Nuplazid's strong showing in DRP could spell blockbuster hopes for the drug despite a key failure in schizophrenia earlier this year, J.P. Morgan analyst Cory Kasimov wrote in a note to investors.
SVB Leerink analyst Marc Goodman called the data "very strong" and bumped up peak sales for a possible Nuplazid DRP indication from $2 billion to $2.5 billion. Three key opinion leaders attending CTAD event backed up the strength of Nuplazid's results, he said.
"The (leaders) agreed that the data were very clinically meaningful results that were strong compared to the current standard of care (off-label antipsychotics), which have poor tolerability, can negatively impact cognition, and can cause movement disorders," Goodman wrote.
Back in July, Acadia pulled the plug on trials adding Nuplazid to antipsychotics as a treatment for previously treated schizophrenia patients after phase 3 trial results showed little clinical benefit over placebo.
Despite that major hit, Acadia came back last month with phase 2 trial data showing Nuplazid added to standard-of-care antipsychotics bested antipsychotics alone in reducing the negative symptoms of schizophrenia after 26 weeks in patients with controlled positive symptoms.
Acadia said it would launch a second pivotal study for the 34-milligram dose of Nuplazid in the first half of 2020, with additional results from the Advance study set to be presented at a future medical meeting.