Indian pharmaceutical company Suven Life Sciences has failed to meet the primary endpoint in its Phase IIA proof-of-concept study that evaluated the efficacy, safety and tolerability of masupirdine (SUVN-502) for the treatment moderate Alzheimer’s disease.

The trial was conducted at centres across the US and focused on advanced-stage Alzheimer’s patients (moderate Alzheimer’s) treated with standard of care donepezil and memantine.

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The triple-therapy consists of masupirdine, donepezil and memantine and is based on pre-clinical cognition models where masupirdine enhanced the effects of combined treatment with donepezil and memantine.

Masupirdine is a selective serotonin 6 receptor antagonist being developed for the symptomatic treatment of Alzheimer’s dementia.

The primary efficacy endpoint of the study was meaningful improvements from baseline to week 26 in ADAS-Cog 11 score. Secondary outcome measures were MMSE, ADCS-ADL, CDR-SB, NPI, C-SDD, safety and tolerability assessment.

The study found that masupirdine is safe and well-tolerated without significant adverse events. However, the company said that the triple therapy failed to meet its primary endpoint.

Suven Life Sciences said that the sub-population of patients treated with masupirdine showed a significant improvement and reduction in the behavioural symptoms in agitation/aggression and delusions/hallucination as assessed by the NPI subscale scores.

The Phase IIA randomised, double-blind, placebo-controlled, multi-centre, parallel-group study was conducted to compare the efficacy and safety of two doses of masupirdine (50mg and 100mg per day) to placebo in moderate Alzheimer’s patients.

The study involved 564 subjects who had Alzheimer’s for at least one year and scored between 12 and 20 in mini-mental state examination (MMSE).

Patients were being treated with stable doses of either donepezil 10mg/day and memantine 10mg twice a day, namenda XR (memantine) 28mg/day, or namzaric (28mg memantine HCl extended-release/10mg donepezil HCl) once a day for at least three months.

The 30-week study included a 26-week double-blind treatment period followed by a four-week single-blind placebo washout period.

The safety of masupirdine was evaluated through physical and neurological examinations, blood pressure, ECGs, laboratory tests, and a review of adverse events.

Suven Life Sciences said that masupirdine appeared to be well-tolerated in the Alzheimer’s population, with most reported adverse events similar to placebo. There were no significant changes in physical, neurological, cardiology and laboratory tests.

Patients who completed the study were allowed to participate in a compassionate Expanded Access Program (EAP) with masupirdine (50mg daily) for an additional six to 12 months.