Suven starts Phase 3 trial for first home-grown Alzheimer's drug

Now an Indian company working on the country’s first home-grown, potentially affordable Alzheimer’s drug Masupirdine (formerly SUVN 502) is raising hopes for 6.1 million senior citizens in India suffering from dementia. Hyderabad-based Suven Life Sciences (Suven) has started recruiting patients for the Phase 3 trial of this novel drug that could possibly slow cognitive decline.

The company’s stock surged nearly 9 per cent during the day’s trade on the BSE.

Alzheimer’s is a progressive neurological, degenerative disorder that causes the brain to shrink and the brain cells to die. According to a 2021 Lancet study on the burden of neurological disorders in India’s states, Alzheimer’s has claimed 129,000 lives in the country in 2019. About 3.7 per cent, or 6.1 million, senior citizens suffer from dementia. This number is expected to treble by 2050, warns Jasrita Dhir, head-marketing and communications, Antara Senior Living.

Suven said on Wednesday it has started randomisation of the first patient in the Phase 3 global clinical trial of its drug Masupirdine for the treatment of agitation in patients with dementia of the Alzheimer’s type. 

Clinical trial randomisation is the process of assigning patients by chance to groups that receive different treatments.

It is a multi-centre, randomised, double-blind, placebo-controlled study planned across 50 cities in North America and Europe.

“The study will enrol approximately 375 patients who will be randomised 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.

Top-line data from the trial is expected to be available by early 2025.

A new investigational drug from US giant Biogen and Eisai’s Lecanemab (Japan) reduced the pace of cognitive decline in people in the early stage of the disease by 27 per cent over 18 months, the drug firms claimed in October, announcing data from a large-scale trial.

While the benefits came with side-effects like brain swelling and even bleeding, they nonetheless raised hopes and the share prices of these two companies, as around 22 per cent of the global population would be senior citizens by 2050.

Similar drugs are under development from Roche and Eli Lilly and Company.

New drugs, however, are priced beyond the reach of most patients, especially in a country like India.

Biogen’s Aduhelm was launched last year at a price point of $56,000 per year, something that had irked even lawmakers in the US. In January this year, the company halved the Alzheimer’s drug’s price to $28,000 per year, or around Rs 22 lakh per patient in Indian currency.

Doctors say these drugs are out of reach of most patients.

“Biogen’s Aduhelm was priced around Rs 40 lakh when launched. These are mostly outpatient procedures, and very few families have the kind of insurance cover to take care of lofty expenses,” says Praveen Gupta, principal director and head, Department of Neurology, Fortis Memorial Research Institute, Gurugram. He adds that when the incremental benefits are not much, such drugs are unlikely to gain access.

Thus, Suven’s drug, which targets symptoms like agitation in patients with Alzheimer’s, raises hope for Indian patients.

The degenerative ailment

• Hyderabad-based Suven Life Sciences has started recruiting patients for the Phase 3 trial of  Masupirdine 
• Alzheimer’s disease is a progressive neurologic disorder that causes the brain to shrink and brain cells to die. It is the leading cause of dementia
• Alzheimer’s claimed 129,000 lives in the country in 2019, according to a 2021 Lancet study 
• Around 6.1 million senior citizens suffer from dementia; the number is expected to treble by 2050