Suven Life Sciences announces initiation of phase 3 trial of Alzheimer's drug
Hyderabad: Biopharmaceutical company, Suven Life Sciences, has announced the initiation of a phase 3 clinical trial of SUVN-502 (Masupirdine), a 5-HT6 antagonist for the treatment of agitation and aggression in Alzheimer's type dementia.
Suven Life Sciences has informed that SUVN-502 (Masupirdine), a potent, selective, brain penetrant and orally active novel chemical entity, has planned initiation of a global Phase 3 clinical trial for the treatment of agitation and aggression in Alzheimer's type dementias with expected enrollment of patients from the middle of September 2021.
This multi-center study (sites in the US and Europe) comprising about 387 patients is likely to be completed in about 36 months and the topline results are 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, has undergone a phase 2 study on 564 patients for moderate Alzheimer's disease without meeting the primary end point.
However, after an in-depth analysis of the data and intense dialogue with key opinion leaders, Suven Life Sciences has planned a new clinical trial for the treatment of agitation and aggression in Alzheimer's type dementia.
Prior to the initiation of the Phase 2A study, SUVN-502 had 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.
Suven Life Science is a biopharmaceutical company focused on discovering, developing, and commercializing novel pharmaceutical products, which are first in class or best in class CNS therapies using GPCR targets. Suven has 4 clinical stage compounds, this Phase 3 SUVN-502 for Agitation and aggression in Alzheimer's type dementias, ongoing Phase 2 SUVN-G3031 for sleep disorders (Narcolepsy), Phase 1 completed SUVN-911 for Major Depression and Disorder (MDD) and Phase 1 completed SUVN-D4010, a Dual Mechanism of Action (Disease Modifying and Symptomatic Treatment Potential for AD) Gastro-Intestinal Motility Disorders. Apart from this Suven has 11 molecules in development pipeline.