SUVN-502 did not meet the pre-specified primary endpoint
Meaningful improvements and potential beneficial effects on cognitive function, behavioral and neuropsychiatric end points were emerged based on subgroup analyses.
SUVN-502 was safe and well tolerated with no significant adverse events
Suven Life Sciences announces top-line results from its Phase 2A proof of concept study evaluating the efficacy, safety and tolerability of Masupirdine (SUVN-502). The first of its kind trial which focused on advanced stage AD patients (moderate AD) who are currently treated with standard of care Donepezil and Memantine. The unique triple-therapy (Masupirdine+ Donepezil+ Memantine) design was based on efficacy results in pre-clinical cognition models in which masupirdine enhances the effects of combined treatment with Donepezil and Memantine.
The primary efficacy endpoint of the trial is change from baseline to Week 26 in ADAS-Cog 11 score. The secondary outcome measures are MMSE, CDR-SB, ADCS-ADL, NPI, C-SDD, safety and tolerability assessment.
Findings of this Phase 2A study:
- Masupirdine (SUVN-502) is safe and well tolerated without significant adverse events.
- Triple therapy of Masupirdine (SUVN-502) with Donepezil and Memantine proof of concept phase 2 study missed its pre-specified primary endpoint.
- Subgroup analyses on cognition, function, behavioral, neuropsychiatric inventory and secondary endpoints revealed interesting, statistically significant and potentially beneficial data sets.
- Potential beneficial effects and statistically significant results with Masupirdine treated groups on cognition emerged upon considering combinations of Patients Age, Memantine regimen, Memantine plasma concentration, Memantine treatment duration and Alzheimer's disease duration.
- Sub-population of Masupirdine treated patients showed significant improvement and statistically significant reduction in the behavioral symptoms in the domains of agitation / aggression and delusions /hallucination as assessed by the NPI subscale scores.
- Detailed study outcomes of the above findings will be presented through one oral and six poster presentations at Clinical Trials on Alzheimer's Disease (CTAD) being held at San Diego from 4th - 7th December 2019.
We are very disappointed with the outcome of this trial but the findings present an important step forward in further exploration of the potential therapeutic effects of Masupirdine (SUVN-502) in Alzheimer's Disease (AD) and Behavioral & Psychological Symptoms in Dementia (BPSD). We will work with regulators and potential partnering companies in the design and conduct of future studies for further exploration of the potential of Masupirdine (SUVN-502) says Venkat Jasti, CEO of Suven.
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