HQ Team
April 23: Bristol Myers Squibb’s investigational oral drug for treating schizophrenia in adults failed in its main goal to treat symptoms in patients who are already on regular medication.
The primary goal of the study was to find out if adding a new medicine called Cobenfy to a patient’s usual schizophrenia medicine helps improve their symptoms more than just taking their usual medicine with a placebo or a dummy pill with no active drug.
To measure this, researchers used a standard test called the PANSS score, which checks how severe a person’s schizophrenia symptoms are and is a common rating scale for schizophrenia. They looked at how much this score changed after six weeks of treatment.
People who took Cobenfy with their regular medicine showed more improvement in their symptoms than those who took just their regular medicine and a placebo.
Not ‘statistically significant’
The difference was not big enough to be sure it wasn’t due to chance, or was not “statistically significant” after six weeks. In some smaller groups, like those taking a specific medicine called risperidone, the improvement with Cobenfy seemed more noticeable, but this needs more research.
Bristol stated the study “did not reach the threshold for statistical significance for the primary endpoint. Cobenfy’s safety and tolerability profile as an adjunctive treatment was consistent with previous monotherapy trials.”
Adjunctive treatment is an additional treatment alongside the primary treatment to help improve its effectiveness. It is not the main treatment itself, but is used to support, assist, or enhance the results of the primary therapy.
“Adjunctive treatment trials in schizophrenia present significant clinical and methodological challenges,” said Husseini Manji, MD, FRCPC, Co-Chair, UK Government Mental Health Goals Program and Professor, Department of Psychiatry, Oxford University.
Persistent symptoms
“When patients are already receiving treatment, demonstrating additional statistical benefit becomes inherently more difficult. However, it’s common for individuals to continue to experience persistent symptoms, and prescribers have adopted an approach to address this significant unmet need through adjunctive use.”
Even though the oral medication “did not demonstrate a statistically significant improvement as an adjunctive treatment in this trial, the data are encouraging, showing a noteworthy improvement for the majority of patients in the trial, as well as a tolerable safety profile,” according to the statement.
These findings needed additional follow-up and could provide valuable direction in the company’s ongoing search for complementary approaches to address these persistent treatment gaps, said Manji.
Samit Hirawat, MD, executive vice president, chief medical officer and head of development at Bristol Myers Squibb said: “Historically, the development of an effective, adjunctive treatment for schizophrenia has been difficult due to inherent challenges like variable patient response, stringent trial design requirements, and the complexities of demonstrating incremental benefits beyond established antipsychotics.”
‘Potential next steps’
“Despite the complex and challenging nature of adjunctive studies, we wanted to pursue research in this area to help more patients struggling with this condition. While the primary endpoint in this trial did not meet statistical significance, we need to complete our analysis and will plan to engage with the medical community and regulators to discuss these results and potential next steps.”
Schizophrenia is a persistent and often disabling mental illness impacting how a person thinks, feels and behaves.
There are three symptom domains of schizophrenia, which include positive symptoms (hallucinations, delusions, disordered thinking and speech), negative symptoms (lack of motivation, lack of emotional expression, social withdrawal) and cognitive dysfunction (impaired attention, deficits in memory, concentration and decision-making).
The symptoms of schizophrenia can affect all areas of people’s lives, making it difficult to maintain employment, live independently and manage relationships.
Schizophrenia affects nearly 24 million people worldwide, including 2.8 million people in the US, and is one of the top 15 leading causes of disability worldwide.
