Cognition Therapeutics Stock Tumbles On Mixed Data From Mid-Stage Alzheimer's Study

On Monday, Cognition Therapeutics, Inc. CGTX reported that participants in the proof-of-concept Phase 2 ‘SHINE’ study who were treated with CT1812 for six months showed a consistent trend in cognitive improvement compared to placebo across all cognitive measures.

In addition, there were signals of improvement in functional measures.

Details of these clinical and biomarker findings were shared at the Alzheimer’s Association’s International Conference.

SHINE enrolled 153 adults with mild-to-moderate Alzheimer’s disease who were randomized evenly (1:1:1) to one of two oral daily doses of CT1812 (100mg or 300mg) or placebo.

On ADAS-Cog 11 and MMSE (cognitive decline scales) at Day 98, the study’s midpoint, P-values less than 0.05, were observed.

Through the course of the study, participants in the placebo arm worsened by approximately 2.70 points as measured by ADAS-Cog 11 on Day 182.

CT1812-treated participants declined by an average of 1.66 points, a 39% slowing of decline favoring CT1812.

Similar results were seen in the MMSE score on Day 98 for the pooled CT1812 arms.

On the exploratory measures of function (ADCS-ADL and CGIC), there was a signal of benefit favoring CT1812 at the six months.

CT1812 did not achieve statistical significance on the first of the ordered secondary efficacy endpoints in the pooled 100mg and 300mg dose group compared to placebo.

CT1812 demonstrated a favorable safety and tolerability profile, with most treatment-related adverse events being mild or moderate, consistent with previous clinical experience.

The SHINE study demonstrated a favorable safety and tolerability profile, consistent with previous clinical experience.

At the 300mg dose, nine patients experienced treatment-emergent liver function tests (LFT) increases, which subsided after cessation of the drug without evidence of serious liver injury. No LFT elevations were observed in the 100mg dose.

Last year, Cognition Therapeutics announced the topline results from its Phase 2 double-blind, single-crossover SEQUEL study of CT1812 in 16 adults with mild-to-moderate Alzheimer’s disease.

Price Action: CGTX stock is down 35.10% at $1.54 at the last check on Monday.

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