Suven Life Sciences Completes 424-Patient Phase 3 Enrollment for Masupirdine in Alzheimer's Dementia Agitation

The multicenter, randomized, double-blind, placebo-controlled Phase 3 study was conducted across sites in the US and Europe. Patients were randomized in a 1:1:1 ratio to receive Masupirdine 50 mg, Masupirdine 100 mg, or placebo once daily for 12 weeks.

The primary endpoint is the change from baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) items corresponding to the International Psychogeriatric Association (IPA) agitation criteria. The key secondary endpoint is the modified Alzheimer’s Disease Cooperative Study–Clinical Global Impression of Change (mADCS-CGI-C), which assesses agitation-related clinical change.

The study was designed to randomize approximately 375 patients. However, as several patients were already undergoing screening when the enrollment target was reached, those who subsequently met all eligibility criteria were permitted to proceed to randomization in accordance with protocol-defined procedures. As a result, a total of 424 patients were randomized into the study.

Safety data from the study are being monitored continuously, with the company stating that no safety concerns have been observed to date.

Commenting on the enrollment milestone, Venkat Jasti, Chairman and Managing Director, Suven Life Sciences, said, “We are pleased to announce that we have completed the enrollment for our Masupirdine Phase-3 clinical study. The strong enrollment in the Masupirdine trial highlights the significant unmet need for new treatment options for the management of Agitation associated with Alzheimer's disease. We are grateful for the enthusiasm and commitment of the study participants, caregivers, investigators, and site staff, whose dedication contributed to the efficient conduct of the trial. We remain very optimistic of completion of this study with definitive timelines and look forward to bring a new therapy to AAD.”

Ramakrishna Nirogi, President and Chief Scientific Officer, Suven Life Sciences, said, “Masupirdine is a highly selective 5-HT6 receptor antagonist with a differentiated pharmacological profile and has demonstrated a favorable efficacy and tolerability profile throughout its non-clinical and clinical development. Current pharmacological approaches to the management of agitation associated with Alzheimer’s dementia rely predominantly on sedative mechanisms or antipsychotic agents. Sedation and the adverse-effect profile associated with antipsychotics, including potential cardiac risks present significant limitations, particularly in this vulnerable patient population. Masupirdine, with its distinct and novel mechanism of action, has the potential to address several of these limitations and provide meaningful differentiation from existing treatment options.”

Masupirdine is being evaluated as a potential treatment for agitation associated with Alzheimer’s dementia, one of the neuropsychiatric symptoms that can significantly affect patients with Alzheimer’s disease and increase caregiver burden and functional impairment.

The study is registered on ClinicalTrials.gov under NCT05397639 and has been assigned EudraCT Number 2021-003405-22.

Masupirdine is a potent and highly selective 5-HT6 receptor antagonist with favorable pharmacokinetic properties. According to Suven, preclinical studies showed that the drug attenuated aggressive behaviors and modulated neurotransmitter pathways implicated in neuropsychiatric symptoms. In a clinical study, Masupirdine demonstrated a reduction in agitation and aggression in patients with Alzheimer’s disease.

Suven Life Sciences is focused on the discovery and clinical development of medicines addressing unmet medical needs in CNS disorders. Its clinical and research portfolio includes programs targeting Alzheimer’s disease, sleep disorders, major depressive disorder, Parkinson’s disease, schizophrenia, pain disorders and gastrointestinal disorders.

The company currently has five clinical-stage assets, including Masupirdine (SUVN-502) for agitation in patients with dementia of the Alzheimer’s type; Samelisant (SUVN-G3031) for excessive daytime sleepiness in narcolepsy; Ropanicant (SUVN-911) for major depressive disorder; Usmarapride (SUVN-D4010) for cognitive disorders; and SUVN-I6107 for cognitive disorders.