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 Phase 2A trial is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of SUVN-502 for the treatment of moderate Alzheimer’s Disease (AD).This trial is expected to enrol 537 patients and the primary objective of the study is 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. The trial is likely to complete by end of second quarter 2017, subject to the achievement of estimated 12 months’ enrolment goal in USA.
Secondary objectives of this POC study are to further evaluate the efficacy of these treatments usingClinical 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).
This study is being coordinated by Dr. Jeffrey Cummings, MD, Director, Cleveland Clinic Lou RuvoCenter for Brain Health, Las Vegas, NV, USA.
Prior to the initiation of 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.