ACADIA Pharma Shares Slide as Alzheimer's Drug Trial Narrowly Misses Primary Goal

Shares of ACADIA Pharmaceuticals (NASDAQ: ACAD) declined significantly in pre-market trading after the company announced that its Phase 2 RADIANT trial for remlifanserin, an investigational treatment for Alzheimer's disease psychosis, narrowly missed its primary endpoint.

Trial Results in Detail

The topline results showed that the 60 mg once-daily dose of remlifanserin did not achieve statistical significance compared to a placebo. The primary goal was to measure the change in hallucinations and delusions at week six using the SAPS-H+D scale.

Key data points from the trial include:

• The 60 mg dose produced a change of -12.6 on the SAPS-H+D scale, compared to -10.4 for the placebo.
• This resulted in a p-value of 0.0603, just above the 0.05 threshold typically required to be considered statistically significant.

While the primary endpoint was not met, the company reported that a key secondary endpoint, the CGI-S-ADP scale, did show a nominally significant improvement with a p-value of 0.0077. The drug also demonstrated a favorable safety profile, comparable to the placebo.

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Company Plans and Market Reaction

Despite the setback on the primary goal, ACADIA confirmed it will continue enrolling patients in its two ongoing Phase 3 studies for remlifanserin. The company will amend the program to remove a lower 30 mg dosage arm, which showed minimal improvement over the placebo in the Phase 2 trial.

CEO Catherine Owen Adams stated that the data from the Phase 2 study support the continuation of the Phase 3 program and provide valuable information on the drug's efficacy. However, investors reacted negatively to the news, with the stock falling 8.1% in pre-open trading. The failure to achieve a clear win on the primary endpoint for what was considered a major pipeline catalyst has been the dominant driver of the sell-off.

Broader Market Context

Adding to the pressure on ACADIA's stock is a challenging broader market environment. Major indices, including the S&P 500 and Nasdaq, were trading lower amid renewed inflation concerns fueled by surging U.S. Treasury yields. This risk-off sentiment is creating additional headwinds for biotechnology stocks and other risk assets.