Acadia’s Nuplazid suffered a big loss in July after a late-stage trial as an add-on treatment for schizophrenia fell flat. But that study wasn’t Nuplazid’s last go at the indication, and now a phase 2 win could help Acadia get over the top.
A high dose of 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, according to top-line data from Acadia’s phase 2 Advance study.
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.
“The positive efficacy results and favorable tolerability profile of (Nuplazid) observed in the Advance study represent an important step forward for patients and their families, given the lack of currently approved treatment options for the negative symptoms of schizophrenia,” Acadia President Serge Stankovic said in a release.
The Advance study tested patients on the Negative Symptom Assessment-16 total score, with symptoms including social withdrawal, apathy, anhedonia, loss of motivation, blunted affect, and restricted speech, Acadia said. Patients in the Nuplazid arm were started on a 20-milligram dose of the drug and randomized during the first eight weeks of treatment to take three different doses.
Fifty-three percent of patients treated with the 34-milligram dose of Nuplazid showed improvements in their negative symptoms over antipsychotics alone, hitting the study’s primary endpoint. On the secondary endpoint––improvement on the Personal and Social Performance scale––Nuplazid showed no significant difference over antipsychotics alone.
Analysts expressed cautious optimism over the data, nothing that Acadia’s planned second trial could take years to back up those results.
That trial will likely last between two and two-and-a-half years, SVB Leerink analyst Marc Goodman wrote in a note to clients. That timeframe led the firm to push back its potential launch date for Nuplazid in schizophrenia to 2023.
“We were clearly too aggressive in our previous launch assumption,” Goodman wrote. Still, he’s predicting a possible $750 million in peak sales in the indication.
J.P. Morgan analyst Cory Kasimov backed up that sentiment in his own note to clients, calling the Advance results “incremental” but positive for Nuplazid’s schizophrenia hopes.
RELATED: Acadia calls early halt to Nuplazid psychosis trial after promising interim results
The positive sign is important for Acadia after Nuplazid flopped a phase 3 trial in July as an add-on to antipsychotics. That study examined the drug’s ability to treat the symptoms of schizophrenia in patients who showed no improvement on prior antipsychotics.
Despite that loss, Acadia did score a major trial win in September, halting its phase 3 Harmony study after the drug showed a significant reduction over placebo in time to relapse for patients with DRP. 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.
Acadia is already FDA-approved to treat the symptoms of Parkinson’s-related psychosis.
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, Kasimov said in a previous note to investors. Even with a schizophrenia loss, Kasimov said other studies in that indication present “potential upside” for the drug’s forecast.
