Suven Life Sciences announced top-line results from its Phase 2A proof of concept study evaluating the efficacy, safety and tolerability of Masupirdine (SUVN-502) in patients with moderate Alzheimer’s disease who were simultaneously being treated with standard of care Donepezil and Memantine. The trial failed to meet the primary endpoint of the change from baseline to Week 26 in ADAS-Cog 11 score.
The phase 2A study was a randomized, double-blind, placebo-controlled, multi-center, parallel group design and enrolled a total of 564 subjects with a diagnosis of AD for at least one year, MiniMental State Examination (MMSE) scores between 12 and 20, and were being treated with stable doses of both Donepezil and Memantine. The trial compared two doses of Masupirdine (50 mg and 100 mg per day) to placebo. This 30-week study included a 26-week double-blind treatment period followed by a 4-week single-blind placebo washout period.
Masupirdine (SUVN-502) was safe and well tolerated without significant adverse events. However, the triple therapy of Masupirdine (SUVN-502) with Donepezil and Memantine missed its pre-specified primary endpoint. Meaningful improvements and potential beneficial effects were observed on cognitive function, behavioral and neuropsychiatric endpoints based on subgroup analyses. Detailed study outcomes 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.
About Masupirdine (SUVN-502)
Masupirdine (SUVN-502) is a selective serotonin 6 (5-HT6) receptor antagonist (>1200 fold selectivity over 5-HT2A) in development as a novel approach in the symptomatic treatment of AD dementia. In preclinical studies, masupirdine demonstrated excellent ADME properties; promising pro-cognitive effects; robust psychophysiological and biochemical signals; and a good safety profile. In animal models assessing behavior neurochemistry and electrophysiology, Masupirdine + Donepezil + Memantine triple combination demonstrated superior pro-cognitive effects (object recognition task), acetylcholine modulation (microdialysis) and theta modulation (electrophysiology) compared to Donepezil + Memantine dual combination. Long-term animal toxicity studies with Masupirdine, Donepezil, and Memantine did not identify any significant toxicity risk signal; suggesting a broad exposure safety margin. In healthy younger and older adult human subjects, Masupirdine was well-tolerated following single or multiple oral administrations.