Bristol Myers Squibb schizophrenia drug fails key tests as an additional function of antipsychotics
Landmark FDA approval for Bristol Myers Squibb drug introduced the first novel mechanism for the treatment of schizophrenia over decades, which failed critical tests designed to support the expansion of its use, which was a disappointing result, which made the expected large chunk of products have a big impact in the commercial outlook.
The third phase of the test evaluates the drug Cobenfy, an adjunct to atypical antipsychotics in adults, whose schizophrenia symptoms are undercontrolled by these standard of care medications. In preliminary results released after the market shutdown Tuesday, BMS said that the change in Cobenfy's score changed based on the scale used to assess symptoms of mental illness, but the change measured in Week 6 was not statistically significant compared to placebo. BMS said Cobenfy's safety is consistent with previous tests on the drug.
BMS points to a highlight in the preliminary data. The company said the post hoc analysis showed that “the difference in responses was significant” in patients whose background treatment was not risperidone, a common atypical antipsychotic. However, expanding Cobenfy's approval for use on top of felithrethreonone antipsychotics may require another clinical trial. BMS Chief Medical Officer Samit Hirawat said in a prepared statement that due to the variable responses of patients, the rigorous trial design and the complexity of incremental benefits beyond established antipsychotics.
“Although the complex and challenging nature of auxiliary research, we want to do research in this area to help more patients struggle in this situation,” he said. “Although the primary endpoints in the trial are not statistically significant, we need to complete the analysis and plan to interact with the medical community and regulators to discuss these results and potential next steps.”
Cobenfy is an oral small molecule designed to target and block muscarinic receptors in the brain. The drug is formulated as a twice-daily capsule that selectively targets the M1 and M4 receptors without hitting other muscarinic receptors that may trigger side effects. Cobenfy came to BMS through the pharmaceutical giant's $14 billion acquisition of its developer Karuna Therapeutics.
Last September, the FDA approved Cobenfy as an independent treatment for adult schizophrenia, marking the first regulatory nod of emerging muscarinic receptor-targeted drugs. The drug is expected to become a blockbuster seller, and BMS has been conducting additional clinical testing to support the potential expansion of the product’s use. In addition to a key test of cobenfy's adjuvant therapy for schizophrenia, BMS also conducted a clinical trial to evaluate the drug as a treatment for Alzheimer's-related psychiatric disorders.
Financial analysts still make the project Cobenfy project a sensational product, but it won't be as big as hoped. Leerink Partners analyst David Risinger said in a note sent to investors that the trial results showed that the drug's efficacy was moderate, “We are worried about one [twice-daily] The potential of doses of antipsychotics with moderate efficacy is much lower than we initially expected. “In contrast, older antipsychotics offer once-daily doses, and even less dosing schedules.
William Blair analyst Matt Phipps is more optimistic about Cobenfy's business prospects. He said in a study notice that although the trial failure hit Cobenfy's market absorption strategy, clinical research on Alzheimer's-related psychiatric disorders is still underway. He said achieving clinical success in this indication through tolerant safety would represent a great market opportunity. Phipps added that when the company reported first-quarter financial results on Thursday, he would look for BMS to provide more details on Cobenfy launches and long-term market opportunities.
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