Acadia Pharmaceuticals Inc. (ACAD)

[Investors3]

https://ih.advfn.com/stock-market/NASDAQ/acadia-pharmaceuticals-ACAD/stock-news/81220617/acadia-pharmaceuticals-announces-positive-top-line

ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), today announced positive top-line results from its ADVANCE study, a 26-week, randomized, double-blind, placebo-controlled study in 403 patients. ADVANCE evaluated the efficacy and safety of adjunctive pimavanserin treatment in patients with predominantly negative symptoms of schizophrenia who have achieved adequate control of positive symptoms with their existing antipsychotic treatment. No drug is approved by the FDA for the treatment of the negative symptoms of schizophrenia.

Pimavanserin demonstrated a statistically significant improvement on the study’s primary endpoint, the change from baseline to week 26 on the Negative Symptom Assessment-16 (NSA-16) total score, compared to placebo (-10.4 vs. -8.5; p=0.043; effect size = 0.21). A 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, effect size = 0.34). In this study, pimavanserin did not separate from placebo on the key secondary endpoint, the Personal and Social Performance (PSP) scale.

ACADIA plans to commence a second pivotal study with the 34 mg dose of pimavanserin in the first half of 2020. Additional results from the ADVANCE study will be presented at future scientific meetings.

“The negative symptoms of schizophrenia such as social withdrawal, apathy, anhedonia, loss of motivation, blunted affect, and restricted speech contribute significantly to low function levels, long-term disability, and increased caregiver burden,” said Dr. Henry A. Nasrallah, M.D., Professor of Psychiatry, Neurology, & Neuroscience, Director, Neuropsychiatry and Schizophrenia Programs, at the University of Cincinnati College of Medicine. “Historically, it has been a challenge for clinicians to treat and significantly improve the negative symptoms of schizophrenia. There are no FDA-approved treatments indicated for the treatment of the negative symptoms of schizophrenia and there remains a serious and significant unmet need.”

“The positive efficacy results and favorable tolerability profile of pimavanserin 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,” said Serge Stankovic, M.D., M.S.P.H., ACADIA's President. “We are pleased with the positive efficacy findings in this difficult to treat patient population and identified the 34 mg dose as demonstrating greater efficacy with favorable tolerability. We look forward to initiating a second pivotal study with the 34 mg dose during the first half of 2020.”

In the study, pimavanserin was well-tolerated with high completion rates of approximately 86% in both the pimavanserin and placebo treatment groups 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.

About ADVANCE...