Neuroscience company Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) disclosed on Monday that it has commenced a Phase 2 clinical trial for ACP-204, targeting hallucinations and delusions linked to Alzheimer's disease psychosis (ADP).
Over 6.5 million Americans with Alzheimer's face psychosis, affecting 30%. The company's global Phase 2 trial includes 318 patients assessing ACP-204 doses (30 mg and 60 mg) versus placebo, focusing on the Scale for the Assessment of Positive Symptoms–Hallucinations and Delusions subscales (SAPS-H+D) total score at Week 6.
This trial seamlessly transitions into two Phase 3 studies, each enrolling about 378 ADP patients. Participants completing the study may join a long-term open-label extension.
Alzheimer's disease psychosis, impacting 30% of AD patients, lacks FDA-approved drugs. ACP-204, an inverse agonist at the 5-HT2A receptor, addresses this unmet medical need, highlighting Acadia's commitment to advancing neuroscience breakthroughs for conditions like schizophrenia, Prader-Willi syndrome and neuropsychiatric symptoms in CNS disorders.
argenx advances ARGX-119 to registrational study for congenital myasthenic syndromes
hVIVO supports Cidara Therapeutics' positive Phase 2b influenza study results
Sanofi's riliprubart receives orphan drug designation in Japan for CIDP
HUTCHMED gains China approval for ORPATHYS and TAGRISSO combination in lung cancer
Hikma Pharmaceuticals USA announces USD1bn of new US investment
UCB reports positive Phase 3 results for fenfluramine in CDKL5 deficiency disorder