Acadia Pharmaceuticals’ phase 2 Alzheimer’s disease trial has missed its primary endpoint, but the company and analysts alike saw enough encouraging signals to support the continuation of a phase 3 program.

San Diego-based Acadia generated the data in the first part of the phase 2/3 Radiant trial. Acadia is running the study to compare remlifanserin, a 5HT2A receptor inverse agonist, to placebo in patients with Alzheimer’s psychosis. Remlifanserin, which is also called ACP-204, hits the same target as Acadia’s Nuplazid but is designed to be less prone to causing QT prolongation, a cardiac adverse event.

In the phase 2 part of the Radiant trial, Acadia linked the 60-mg remlifanserin dose to a 12.6-point drop on an assessment of hallucinations and delusions at Week 6. The biotech reported a 10.4-point decline on placebo, resulting in a 0.26 effect size and a missed primary endpoint. TD Cowen analysts named an effect size of 0.35 to 0.4 as the most likely outcome in a Sept. 15 note to investors.

Acadia fell short of those expectations. However, with the p-value coming in at 0.0603—just above the 0.05 statistical significance threshold—BMO Capital analysts characterized the result as a “near miss” in a note to investors. The analysts added that “some encouraging signals support future development.”

Acadia CEO Catherine Owen Adams went further, saying she was “very encouraged by the results.”

“We believe with the high unmet medical need in this population, the efficacy that we've seen so far ... as well as the safety and tolerability profile, that this molecule offers the potential for patients with Alzheimer's disease psychosis, and it is absolutely worth our investment to move this forward into the phase 3 trial,” Adams said on a conference call with investors to discuss the data.

Source link