Promising Phase 2 Results for New Dementia with Lewy Bodies Treatment

Cognition Therapeutics Inc. has announced encouraging topline results from its Phase 2 SHIMMER study for CT1812, a novel oral treatment for dementia with Lewy bodies (DLB). The clinical-stage biopharmaceutical company, focused on developing therapies for neurodegenerative disorders, reported that CT1812 demonstrated strong therapeutic responses across multiple measures in patients with DLB, a rapidly progressing form of dementia that affects approximately 1.4 million people in the United States.

The SHIMMER study, which enrolled 130 adults, evaluated the safety and efficacy of CT1812 over a six-month period. Participants received either a placebo or one of two doses of CT1812 (100 mg or 300 mg) once daily. The trial met its primary endpoint of safety and tolerability, with patients treated with CT1812 showing improvements in behavioral, functional, cognitive, and movement measures compared to those receiving the placebo.

Notably, the study reported an 82% slowing in the total neuropsychiatric inventory, with significant reductions in anxiety, hallucinations, and delusions among patients treated with CT1812. The drug also demonstrated a marked reduction in caregiver distress, suggesting a positive impact on the daily lives of both patients and their caregivers. Cognitive measures showed a slowing of decline across all three assessed areas, including a 91% reduction in fluctuations in attention for those receiving CT1812.

Dr. Anthony Caggiano, Cognition's Chief Medical Officer and Head of R&D, expressed enthusiasm about the results, stating that they exceeded expectations and support the broad potential of CT1812 across neurodegenerative disorders. The company plans to present detailed data at the International Lewy Body Dementia Conference in January 2025 and will review the findings with the FDA in an end-of-phase 2 meeting.

The significance of these results cannot be overstated. DLB is currently the costliest form of dementia, and there are no existing cures for this debilitating condition. Current treatments focus solely on managing symptoms and are often used off-label. The development of CT1812 could represent a major breakthrough in the treatment of DLB, potentially offering the first targeted therapy for this form of dementia.

The SHIMMER study's success follows promising results from Cognition's earlier Phase 2 SHINE study, which examined CT1812's effects on mild-to-moderate Alzheimer's disease. That study demonstrated a 95% slowing of cognitive decline in individuals with a key Alzheimer's biomarker, further supporting the drug's potential across multiple neurodegenerative disorders.

Lisa Ricciardi, Cognition's President and CEO, emphasized the broad neurologic and neuroprotective activity demonstrated by CT1812 in both DLB and Alzheimer's disease. The company is now poised to advance CT1812 to late-stage clinical trials, with the goal of providing a once-daily pill that could treat these devastating neurodegenerative conditions.

The implications of this development extend beyond the immediate benefits for patients and caregivers. If successful in later-stage trials, CT1812 could significantly reduce the economic burden of DLB on healthcare systems and families. Moreover, the drug's potential efficacy in multiple neurodegenerative disorders suggests a possible paradigm shift in how these conditions are treated, potentially leading to more targeted and effective therapies for a range of related diseases.

As the global population ages and the prevalence of neurodegenerative disorders increases, the need for effective treatments becomes ever more pressing. The positive results from the SHIMMER study offer a glimmer of hope in the challenging landscape of dementia research and treatment. While further studies are needed to confirm these initial findings, the potential impact of CT1812 on the lives of millions affected by DLB and other forms of dementia is profound, marking a significant step forward in the fight against these devastating conditions.