Key Takeaways:
The FDA granted Fast Track designation to Acadia Pharmaceuticals' remlifanserin for Alzheimer's disease psychosis, the company said July 20.
"Fast Track designation from the FDA highlights the serious need for new therapies in Alzheimer's disease psychosis, a condition with no approved treatments," Catherine Owen Adams, chief executive officer of Acadia, said.
Remlifanserin is an investigational, highly selective 5-HT2A receptor inverse agonist believed to reduce hallucinations and delusions by restoring cortical excitatory/inhibitory balance without blocking dopamine D2 receptors. The phase 2 portion of the phase 2/3 RADIANT trial evaluating 30mg and 60mg daily doses is fully enrolled, with primary endpoint data expected between September and October. The primary endpoint is the change from baseline to week 6 on the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales total score. Screening and enrollment for the phase 3 confirmatory studies are already underway under the program's integrated operational design.
Alzheimer's disease psychosis affects an estimated 30 percent to 50 percent of the 6.5 million Americans living with Alzheimer's, yet no FDA-approved therapies exist for the indication. Acadia's Nuplazid, which targets the same 5-HT2A receptor mechanism, generated $167 million in first-quarter sales for Parkinson's disease psychosis. The company expects combined Nuplazid and Daybue sales to reach about $1.7 billion by 2028.
Acadia is also evaluating remlifanserin in a separate phase 2 study for Lewy body dementia psychosis, another indication with limited treatment options.
The Fast Track designation could shorten the review timeline for remlifanserin's eventual marketing application, potentially accelerating its path to market. Investors will focus on the phase 2 data readout in the coming months, which will determine whether the program advances to a pivotal phase 3 filing.
This article is for informational purposes only and does not constitute investment advice.
