Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) shares dropped on Tuesday after the firm announced results from its late-stage study for the treatment of adult schizophrenia patients with persistent inadequate response to their current antipsychotic therapy. Specifically, the results are coming from the Phase 3 Enhance study evaluating pimavanserin.
In the study, 396 patients with moderate-to-severe psychotic symptoms were randomized to receive either pimavanserin or placebo added to their current antipsychotic treatment. There is currently no FDA-approved adjunctive treatment for schizophrenia patients with inadequate response to existing therapies.
Ultimately, adding pimavanserin to existing antipsychotic treatment showed a consistent trend in improvement of psychotic symptoms. However, the results did not achieve statistical significance on the primary endpoint. Although, a positive trend also was observed on the key secondary endpoint.
Pimavanserin was well tolerated with similar rates of adverse events between adjunctive pimavanserin (40.4%) and adjunctive placebo (36.9%). Adverse events reported in at least 5% of patients in the pimavanserin group included headache, somnolence, and insomnia.
Separately, Acadia is evaluating pimavanserin for adjunctive treatment of schizophrenia patients with predominant negative symptoms in the 26-week Phase 2 Advance study. Top-line results from this study are expected around year-end 2019.
Serge Stankovic, M.D., MSPH, Acadia’s president, commented:
I want to thank all the patients, their families, and the investigators who participated in our Enhance study. Unfortunately, we did not achieve a statistically significant reduction in the PANSS total score in this study. We are pleased with the improvement in negative symptoms observed in this study. We look forward to completing our ongoing Advance trial evaluating pimavanserin in schizophrenia patients with predominant negative symptoms.
Shares of Acadia traded down about 15% to $22.09 on Tuesday, in a 52-week range of $12.77 to $28.67. The consensus price target is $32.55.
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