Cognition Therapeutics (CGTX.US) announced positive results from its Alzheimer's disease drug, CT1812 trial.

On July 29, Cognition Therapeutics (CGTX.US) announced positive results from its Phase 2 Proof of Concept (POC)2 study, SHINE, showing sustained cognitive improvement in patients with mild to moderate Alzheimer’s disease (AD) on its experimental once-daily oral drug, CT1812.

SHINE is a double-blind, placebo-controlled Phase 2 trial that enrolled 153 adults with mild to moderate AD. Participants were randomized to receive either placebo or one of two doses of CT1812 (100mg or 300mg) once daily for six months.

Relative to placebo, participants receiving CT1812 for six months showed consistent cognitive improvement across all cognitive measures and there were also indications of functional improvement.

In particular, CT1812 showed an average cognitive improvement of approximately 40% relative to placebo. Additionally, the study met its primary endpoint and showed good safety and tolerability consistent with prior clinical experience.

“The SHINE trial demonstrates that after 182 days of treatment, CT1812 shows evidence of clinical cognitive improvement and good safety and tolerability, particularly at the 100mg dose. These findings will inform dose selection and provide a foundation for advancing the next stage of clinical development,” said Lisa Ricciardi, CEO.

After the trial data was released, Cognition Therapeutics’ stock briefly surged nearly 50% in pre-market trading.

However, Cognition Therapeutics later indicated that CT1812 failed to statistically outperform placebo on its primary endpoint of a key measure of disease severity, or failed to meet its own success criteria. As a result, the stock turned lower, losing about 28% in intraday trading as of the time of publication.