Acadia was stung hard after its schizophrenia hopes for flagship Nuplazid fell flat back in late July. On the heels of that failure, Acadia is calling off a trial in dementia-related psychosis (DRP) after it saw promising interim results for the drug.
Acadia halted its phase 3 Harmony study for Nuplazid after the drug showed a significant reduction over placebo in time to relapse for patients with DRP, the drugmaker said.
The San Diego-based company said it plans to file for another FDA approval in 2020 and will submit its findings for presentation at upcoming medical meetings.
“We are very excited that today’s results bring us one step closer to the potential of offering patients with dementia-related psychosis a critically needed treatment option,” Acadia’s president Serge Stankovic said in a release.
The DRP win follows a tough stretch for Acadia after Nuplazid’s schizophrenia disappointment and ongoing scrutiny from the Department of Justice (DOJ) over the company’s marketing of the drug.
In a separate phase 3 trial, Nuplazid as an add-on to antipsychotic treatment fell short of its primary endpoints in treating the symptoms of schizophrenia. Acadia said the trial data did show a“consistent trend” in improving psychotic symptoms over placebo in adults who did not respond to previous treatment.
Nuplazid is already approved as the first and only drug to treat Parkinson’s disease psychosis.
Despite those concerns, analyst have seen enough from Acadia's DRP results to update their forecasts to a much rosier outlook for the drug.
With a possible DRP indication in hand by late 2020 or early 2021, Nuplazid could hit $1.8 billion in peak annual U.S. sales, according to J.P. Morgan analyst Cory Kasimov. Even with a schizophrenia loss, Kasimov said other studies in that indication present a "potential upside" in the drug's forecast.
SVB Leerink analyst Marc Goodman said he was surprised by Acadia's decision to call off the trial but highlighted the likely strong efficacy of the drug given that halt.
"We had thought there was low likelihood of this trial stopping early, and that we would have had to wait until next year for the final results when the study continued to completion," Goodman said in a note to investors. "The fact that this trial was stopped early, with the low p-value threshold as a bar for success, suggests that efficacy is strong."
In August, Acadia CEO Steve Davis said the drugmaker had no plans to pursue the same indication in schizophrenia but would continue chasing Nuplazid indications in DRP and major depressive disorder. The drugmaker also has a separate candidate in its pipeline for Rett syndrome.
The newest win could help Nuplazid add to its growing sales after the drug hauled in $83.2 million in the second quarter, a 46% increase over the same period in the previous year and a sign that the drug is “hitting its stride” in Parkinson’s psychosis, Davis said in August.
However, Acadia still has the specter of a DOJ probe hanging over its head.
In 2018, an FDA review of hundreds of deaths among Nuplazid patients resulted in an effective “all-clear” from the agency, which said the drug's risks were consistent with its labeling that includes a black-box warning for an increased risk of death in elderly patients.
In September, the DOJ subpoenaed Acadia’s records on its Nuplazid marketing, and Acadia has said it is cooperating with that request.