Acadia Pharma (ACAD) Announces Publication of Results from ADVANCE Study Evaluating Pimavanserin Treatment for Negative Symptoms of Schizophrenia

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) announced today that The Lancet Psychiatry published results from the Phase 2 ADVANCE study. ADVANCE was an international, 26-week, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of adjunctive pimavanserin treatment in outpatients with moderate-to-severe predominant negative symptoms of schizophrenia who had achieved control of positive symptoms with their ongoing antipsychotic treatment.

ADVANCE met its primary endpoint, with significant improvement observed with pimavanserin for the change from baseline to week 26 on the Negative Symptoms Assessment-16 (NSA-16) total score, compared with placebo (-10.4 vs. -8.5; p=0.043). In a post hoc analysis, greater improvement in the NSA-16 total score compared to placebo was observed in the 53.8% of patients (n=107) who received the highest pimavanserin dose of 34 mg (-11.6 vs. -8.5; unadjusted p=0.0065).

“Negative symptoms of schizophrenia are associated with higher overall morbidity and decreased functioning, and there are no approved treatments,” said Dragana Bugarski-Kirola, M.D., MBA, MSci, Vice President, Clinical Development, Acadia Pharmaceuticals, GmbH. “These findings lend confidence in our continued evaluation of pimavanserin for the treatment of negative symptoms of schizophrenia. We look forward to sharing results of the ongoing, similarly-designed, Phase 3 ADVANCE-2 study, evaluating pimavanserin 34 mg in patients with predominant negative symptoms of schizophrenia.”

In the study, pimavanserin was well-tolerated with high completion rates of approximately 86% in both the pimavanserin and placebo treatment groups through 26 weeks and similar rates of adverse events between pimavanserin (39.8%) and placebo (35.1%). Additionally, no clinically significant differences in vital signs, weight, metabolic syndrome or extrapyramidal symptoms were observed in the pimavanserin group compared to placebo. Serious adverse events were reported in 2.0% of patients on pimavanserin and 0.5% of patients on placebo and discontinuations due to adverse events were also low, 5.0% for pimavanserin and 3.0% for placebo.

“The clinically and statistically significant improvement in negative symptoms of schizophrenia with pimavanserin as an adjunctive treatment with other antipsychotics, combined with the observed favorable tolerability profile, suggest pimavanserin may offer a promising approach in treating negative symptoms of schizophrenia, a severe and difficult condition to treat and significant area of unmet need for patients,” said Henry Nasrallah, M.D., study co-author, Professor-Emeritus, Psychiatry & Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio.

The ADVANCE study is available here.

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