Schizophrenia drug Cobenfy could treat Alzheimer’s

Bristol Myers Squibb believes Alzheimer’s is the biggest marketplace for its newly approved schizophrenia drug, Cobenfy, which it expects to eventually generate billions of dollars in revenue.

In an interview, company executives said each treatment use they’re studying for Cobenfy has multibillion-dollar potential, including Alzheimer’s disease psychosis, Alzheimer’s agitation and Alzheimer’s cognition, bipolar disease, and autism. But Alzheimer’s is the “really large market here,” Bristol Myers Squibb CFO David Elkins told CNBC on Tuesday on the JPMorgan Health Care Conference in San Francisco.

There are nearly 6 million patients within the U.S. with Alzheimer’s, and around half of them have psychosis, or symptoms comparable to hallucinations and delusions, Elkins said. Cobenfy may very well be the primary drug specifically approved for Alzheimer’s-related psychosis, said Chief Commercialization Officer Adam Lenkowsky. 

Atypical antipsychotics – medication used to treat a spread of psychiatric disorders – are sometimes used to treat psychosis in Alzheimer’s patients regardless that they are usually not approved for that purpose. But those treatments can increase the chance of death, and Cobenfy doesn’t, based on Bristol Myers Squibb. 

Meanwhile, Alzheimer’s agitation, a symptom that may cause a patient to feel restless and nervous, is estimated to affect around 60% to 70% of patients with the disease, based on some studies. 

Bristol Myers Squibb on Monday said it plans to release initial late-stage trial data for Cobenfy in Alzheimer’s-related psychosis treatment throughout the latter a part of the 12 months, which is sooner than expected. The corporate also expects to start out phase three trials in Alzheimer’s agitation, Alzheimer’s cognition and bipolar disorder in 2025, while studies in autism will begin in 2026. 

JPMorgan analyst Chris Schott expects Cobenfy sales to achieve about $5 billion by 2030, with a peak sales potential within the $10 billion range across multiple treatment uses, based on a research note on Tuesday. That may be a huge boon to Bristol Myers Squibb because it faces pressure to offset the potential lack of revenue from top-selling treatments that may see their patents expire. 

It is a full-circle moment for Cobenfy, which became the primary novel sort of treatment for the roughly 3 million U.S. adults with schizophrenia in a long time after it won approval in September. The drug comes from Bristol Myers Squibb’s whopping $14 billion acquisition of biotech company Karuna Therapeutics at the top of 2023. 

However the drug’s roots are in treating Alzheimer’s.

Eli Lilly originally tested one a part of the drug – xanomeline – within the Nineties to cut back cognitive decline before shelving it as a result of severe negative effects comparable to nausea, vomiting, diarrhea and constipation. Xanomeline prompts certain so-called muscarinic receptors within the brain to diminish dopamine activity without causing the negative effects related to antipsychotics. 

Andrew Miller, founder and former president of research and development of Karuna Therapeutics and now an advisor to Bristol Myers Squibb, saw xanomeline’s potential in neuroscience and theorized combining xanomeline with a second existing medication – trospium – to cut back those negative effects. He went on to launch Karuna to develop the mix as a schizophrenia treatment.

Other breakthrough treatments for Alzheimer’s recently entered the market, including Biogen and Eisai’s Leqembi and Eli Lilly‘s Kisunla. Those treatments work partly by clearing toxic plaques within the brain called amyloid, a trademark of Alzheimer’s, to slow the decline in memory and pondering in patients within the earliest stages of Alzheimer’s 

But as people progress through their disease, they experience symptoms comparable to psychosis and agitation, Bristol Myers Squibb’s Elkins said. 

“That is where Cobenfy matches it,” he said. “If you happen to can do away with the psychosis, the agitation, people’s cognition improves. Just imagine for the caregivers and health-care system overall, how impactful this drug may very well be for those patients and their family members. It’s really exciting when you concentrate on it in that context.”