Preclinical and clinical data for CT1812 demonstrated that its selective binding to the sigma-2 (σ-2) receptor complex resulted in the displacement of toxic Aβ oligomers. Image credit: Robert Kneschke / Shutterstock.

Cognition Therapeutics’ stock price fell over 43% after the company shared results from its Phase II proof-of-concept SHINE (NCT03507790) trial that demonstrated lead candidate CT1812 failed to show clinically significant change.

A total of 153 adults with mild to moderate Alzheimer’s disease were enrolled on the SHINE trial of CT1812, an orally delivered small molecule oligomer antagonist that binds selectively to the sigma-2 (σ-2) receptor complex and randomised evenly to receive one of two daily doses of CT1812 (100mg or 300mg) or placebo.

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While the decline in the placebo arm worsened by 2.70 points on the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog) by day 182 of the study, those on CT1812 did not fare much better with the pooled average at 1.66 points.

US-based Cognition Therapeutics reported a three-point difference on the ADAS-Cog 11 scale in an evaluation of the first 24 SHINE participants treated with CT1812 versus placebo in November 2023.

For the full results shared, which Cognition framed as a “39% slowing of decline favouring CT1812”, the results reflected a mere 1.04-point difference between the placebo and dosed cohorts.

The results were shared on 29 July in a poster presentation at the 2024 Alzheimer’s Association International Conference (AAIC), taking place in Philadelphia until 1 August.

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Cognition Therapeutics CEO and president Lisa Ricciardi was buoyant on the results, stating that in terms of per cent improvement on evaluated cognitive measures, they were comparable in magnitude to what was achieved with currently approved antibodies.

The Nasdaq-listed company’s stock opened at $2.05 and closed at $1.33 on July 29, reflecting a 43.8% drop off. The stock fell a further 13.5% overnight to date.

Elsewhere in the Alzheimer’s market, C2N Diagnostics revealed findings at AAIC 2024 of its PrecivityAD2 test, demonstrating an accuracy of 90% in identifying Alzheimer’s in patients.

Eli Lilly received approval from the US Food and Drug Administration (FDA) for its amyloid-targeting therapy earlier this month.

Meanwhile, Leqembi (lecanemab) makers Eisai and Biogen were hit with a setback on 29 July as the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion on the marketing authorisation approval for Leqembi in the EU.