SUVN-502 (Masupirdine)
Suven Life Sciences announced Top-Line Results of SUVN-502 (Masupirdine) Phase 2A Study in Patients with Moderate Alzheimer's Disease (AD) in November 2019.
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
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.
Even though the trial did not meet the primary endpoint, 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).
Based on the results of the first phase 2 trial of SUVN-502, a new phase 2 clinical trial is planned for the treatment of Agitation and aggression in Alzheimer's type dementias and the Phase 2 clinical study is likely to commence by 3rd quarter of FY2022. This study expected to be completed in about 42 months (expected completion by end of 2024).
About SUVN-502
SUVN-502 is a pure 5-HT6 receptor antagonist with >1200-fold selectivity over 5-HT2A receptor with a superior profile that differentiates from competitor 5-HT6 antagonists. SUVN-502 has an excellent human pharmacokinetics for once-a-day treatment.
The first Phase 2A trial designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of SUVN-502 for the treatment of moderate Alzheimer’s Disease (AD) commenced in August 2015. This trial enrolled 564 patients in USA and the primary objective of the study was to evaluate the efficacy of a serotonin receptor subtype 6 (5-HT6) antagonist, SUVN-502, at daily doses of 50 mg or 100 mg compared to placebo, as adjunct treatment in subjects with moderate Alzheimer’s disease (Mini-Mental State Examination [MMSE] score of 12 to 20) currently treated with the acetylcholinesterase inhibitor, Donepezil Hydrochloride (HCl) and the N-methyl-D-aspartic acid (NMDA) antagonist, MemantineHCl. Efficacy will be assessed by the 11-item Alzheimer’s Disease Assessment Scale for Cognitive Behaviour (ADAScog-11) after 26 weeks of treatment
Secondary objectives of this POC study were to further evaluate the efficacy of these treatments using Clinical Dementia Rating (CDR) Scale, Sum of Boxes (CDR-SB), MMSE, Alzheimer’s Disease Co-operative Study Activity of Daily Living (ADCS-ADL), Neuropsychiatric Inventory (NPI) 12 item and Cornell Scale for Depression and Dementia (C-SDD).
Prior to the initiation of first Phase 2A study, SUVN-502 has successfully undergone two phase 1 studies in Switzerland and USA on 122 healthy young and elderly male populations with no major adverse events and no serious adverse events.
