Hyderabad-based Suven Life Sciences, which provides drug discovery and development support services to global pharma and biotech companies, has begun phase 3 trials for a home-grown drug to be used on people with Alzheimer’s.
According to a report in the Business Standard, Suven said it had started randomization of the first patient in the phase 3 global clinical trial of its drug Masupirdine (SUVN-502), an antagonist in the treatment of agitation and depression in patients with dementia of the Alzheimer’s type. The drug could slow down cognitive decline.
The company had in a regulatory filing in August last year announced the trials of the multi-center study across the US and Europe, the topline result of which is expected by 2024 or 2025. Clinical trial randomization is the process of assigning patients by chance to groups that receive different treatments.
Alzheimer’s is a progressive neurological, degenerative disorder that causes the brain to shrink and the brain cells to die. A 2021 Lancet study on the burden of neurological disorders in the states of India says Alzheimer’s and other dementia types claimed 129,000 lives in the country in 2019.
“The study will enroll approximately 375 patients who will be randomized in a 1:1:1 ratio to receive Masupirdine — either 50 mg QD, 100 mg QD or placebo QD for 12 weeks,” the company said in a statement.
Similar drugs are under development by Roche and Eli Lilly and Company, the Business Standard report said. New drugs, however, are costly.