Suven Life Sciences informed that  NCE SUVN-502 (Masupirdine), a potent, selective, brain penetrant and orally active, novel chemical entity has planned initiation of global Phase 3 clinical trial for the treatment of Agitation and aggression in Alzheimer's type dementia with an expected enrollment of patients from the middle of September 2021. This multi-centre study (sites in the US and Europe) comprising about 387 patients is likely to be completed in about 36 months and the topline result is expected by the end of 2024.

"Progression of SUVN-502 (Masupirdine) into Phase 3 clinical development is a significant achievement and milestone in enhancing our clinical pipeline. Our lead molecules address niche areas of cognitive impairment associated with neurodegenerative disorders", said Venkat Jasti, CEO of Suven Life Sciences.

SUVN-502 (Masupirdine), a lead clinical candidate having undergone a phase 2 study on 564 patients for moderate Alzheimer's disease without meeting the primary endpoint. After an in-depth analysis of the data and intense dialogue with key opinion leaders, we have planned a new Clinical Trial for the treatment of Agitation and aggression in Alzheimer's type dementias.

Before the initiation of the Phase 2A study, SUVN-502 has successfully undergone two phase 1 studies in Switzerland and the USA on 122 healthy young and elderly male populations with no major adverse events and no serious adverse events.