Cognition Therapeutics reported a positive outcome of an analysis of masked data from the ongoing MAGNIFY phase 2 trial of zervimesine (also known as CT1812) in adults with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). The purpose of this type of analysis, known as a “futility analysis” is to determine if a drug candidate is showing signals of efficacy, the company said in a press release.
Results of the futility analysis from the first 57 participants who completed at least 6 months of dosing showed that zervimesine-treated patients were experiencing a slower lesion growth rate than those on placebo.
To date, the MAGNIFY study (NCT05893537) has enrolled 100 participants. All participants are completing a final clinic visit in February 2025. Cognition said it intends to unblind the study at the end of February and provide a complete analysis of the study, including 12 months of dosing, in the second quarter of 2025. The company said it continues to believe that zervimesine has the potential to alter the biological processes that contribute to dry AMD, and that Cognition and collaborators have generated compelling preclinical evidence to support this.
In December 2024, Cognition reported that the phase 2 SHIMMER study in mild-to-moderate dementia with Lewy bodies (DLB) met its primary endpoint of safety and tolerability. In the DLB study, zervimesine-treated participants performed an average of 86% better than placebo-treated patients on the neuropsychiatric inventory (NPI); 52% better on the ADCS-ADL; 91% better on the clinician’s assessment of fluctuations (CAF); and 62% better on the UPDRS Part III, a measure of motor function such as gait, balance, and tremor.
Cognition’s phase 2 SHINE study of zervimesine in mild-to-moderate Alzheimer’s disease also met its primary endpoint of safety and tolerability. In a biomarker-defined subgroup of the SHINE study, zervimesine-treated participants experienced a 95% reduction of cognitive decline as measured by ADAS-Cog 11 relative to placebo. The company says it plans to schedule end-of-phase 2 meetings with the US Food and Drug Administration to review these results and discuss the design of registrational studies in Alzheimer’s disease and DLB.