Suven Life Sciences presented exploratory sub-group analyses data from Masupirdine (SUVN-502) Phase 2A proof of concept Study in Patients with Moderate Alzheimer's Disease (AD) at the Advances in Alzheimer's and Parkinson's Therapies (AAT-AD/PD™) focus meeting 2020. This meeting, originally scheduled to take place in Vienna, Austria, was converted to a virtual meeting due to the COVID-19 pandemic.
The outcome of the analyses was discussed through a virtual symposium chaired by Dr. Jeffrey Cummings, MD, ScD., USA; Dr. Alireza Atri, MD, PhD, USA highlighted the potential signals of benefit for masupirdine on cognition, function, and global progression in Alzheimer's disease; Professor Clive Ballard, MD, M.R.C. Psych. UK discussed the potential benefits of masupirdine on neuropsychiatric symptoms in patients with Alzheimer's disease. The symposium panel concluded that if the exploratory analyses hold in the confirmatory trial, masupirdine could be a first line treatment option for the management of agitation/aggression in patients with Alzheimer's disease. In addition, the panel also opined that masupirdine may have potential benefit on cognition, function, and global progression in Alzheimer's disease.
Key findings from exploratory analyses:
- In participants whose memantine plasma concentrations were =100 ng/mL at Week 26, there was lesser cognitive decline (ADAS-Cog 11) in participants taking masupirdine than in those on placebo (p<0.05) at Week 26. There were congruent signals for beneficial effects on MMSE, ADCS-ADL, NPI and CDR-SB as well.
- Masupirdine significantly reduced agitation/aggression in patients having baseline symptoms (p<0.001; Cohen's d = 0.45 at Week 13).
- Masupirdine also attenuated delusions and/or hallucinations in patients with dementia of the Alzheimer's type (p=0.016; Cohen's d = 0.58 at Week 13).
- In patients with psychotic symptoms, masupirdine treatment had beneficial effects on cognition (p=0.067; Cohen's d = 0.57 at Week 26).
- Masupirdine showed sustained and durable efficacy on neuropsychiatric symptoms for the entire study duration of 26 weeks.
- Masupirdine is safe and well tolerated without significant adverse events.
These exploratory and thought-provoking observations merit better understanding and further possible investigations of masupirdine effects and its role as a potential future drug in the AD pharmaceutical armamentarium.
This sub-group analysis demonstrates potential utility of Masupirdine in cognition and neuropsychiatric symptoms in patients with Alzheimer's disease as follows:
1. Potential benefit on cognition, function, and global progression in Alzheimer's disease.
2. Potential beneficial effects on several domains of neuropsychiatric inventory related to agitation/aggression and delusions/hallucinations.
3. Potential beneficial effects on cognition in patients with psychotic symptoms.
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