Acadia Pharmaceuticals announced late Monday that its experimental schizophrenia treatment pimavanserin failed in a Phase III trial, sending its stock down about 15% during after-hours trading.
In the Phase III ADVANCE-2 trial, pimavanserin did not lead to a statistically significant improvement in negative symptoms of schizophrenia versus placebo, the study’s primary endpoint. Improvement was measured using the NSA-16 scale, which assesses change in 16 different symptoms including blunted affect, poor socialisation, and lack of motivation.
The 26-week study randomized 454 adults with schizophrenia to receive either 34mg of pimavanserin or placebo.
CEO Steve Davis said that while Acadia will continue to analyse the data with its scientific advisors, “we do not intend to conduct any further clinical trials with pimavanserin.”
Despite Acadia’s schizophrenia setback, patients may not have long to wait before treatments hit the market with a novel mechanism of action – muscarinic receptor modulation.
Earlier this year, FirstWord spoke with Christoph Correll – professor of psychiatry and molecular medicine at Hofstra/Northwell’s Donald and Barbara Zucker School of Medicine and medical director in the department of psychiatry at Zucker Hillside Hospital – who shared excitement over the class’s potential to avoid all five of the key side effects that patients complain about with dopamine D2 therapies. For more, see KOL Views Q&A: Leading psychiatrist sees a muscarinic revolution coming in schizophrenia and beyond.