HQ Team
November 11, 2024: AbbVie Inc.’s two mid-stage trials of an investigational schizophrenia drug have failed to meet its primary goal, according to a company statement.
The trials investigated emraclidine as a once-daily, oral monotherapy treatment for adults with schizophrenia who are experiencing an acute exacerbation of psychotic symptoms.
The experiment “did not meet their primary endpoint of showing a statistically significant reduction (improvement) in the change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score compared to the placebo group at week six,” according to the statement.
The PANSS is a clinical tool designed to assess the severity of symptoms in individuals with schizophrenia. It evaluates the effects of antipsychotic treatments and is extensively used in both clinical practice and research settings.
Reduce excess dopamine
Emraclidine is a specially designed receptor designed to potentially reduce excess dopamine signalling in the brain without blocking other dopamine receptors.
By selectively targeting M4 receptors, emraclidine was supposed to have the potential to reduce psychotic symptoms without interfering with dopamine, serotonin and/or histamine receptors, which is believed to underlie many of the side effects of current antipsychotics.
Schizophrenia is a complex, and debilitating mental health disorder characterized by a constellation of symptoms, including delusions, hallucinations, disorganized speech or behaviour, slowed speech and blunted affect.
The disorder is also often associated with significant cognitive impairment, which further limits a patient’s ability to be gainfully employed and maintain relationships.
Diagnosis of schizophrenia is usually made in young adulthood and the disease follows a chronic and indolent course characterised by periods of remission and relapse.
Cerevel Therapeutics buy
“While we are disappointed with the results, we are continuing to analyze the data to determine the next steps,” said Roopal Thakkar, M.D., executive vice president, of research and development, chief scientific officer, AbbVie.
The setback comes at a time when global revenue for AbbeVie’s Humira, a blockbuster drug used for conditions like rheumatoid arthritis and plaque psoriasis, clocked $3.55 billion, down 36.2% from the prior year. The drug was the world’s most-sold medicine.
In December 2023, AbbVie Inc., bought Cerevel Therapeutics, developing drugs for neuroscience diseases, for $8.7 billion to boost its presence in the psychiatric and neurological disorder segment.
The schizophrenia drug was gained through this acquisition. At that time AbbVie stated that emraclidine had the potential for dementia-related psychosis in Alzheimer’s disease and Parkinson’s disease. More than 10 million people worldwide are living with Parkinson’s.
AbbVie Inc. acquired Aliada Therapeutics, a biotechnology company focused on developing drugs to treat diseases of the central nervous system such as Alzheimer’s disease, for $1.4 billion in cash.
