HQ Team
August 29, 2024: US-based Neurocrine Biosciences’ trial drug for treating schizophrenia reduced the severity of the disease symptoms in a mid-stage study of 210 adult participants.
The dose-finding study met its primary endpoint for the once-daily 20 mg dose, according to a company statement.
The results showed a “clinically meaningful and statistically significant reduction from baseline in the Positive and Negative Syndrome Scale (PANSS) total score with a reduction of 7.5 points in a scale used to measure the severity of symptoms.
“This Phase 2 dose-finding study delivered on our goal of identifying a once-daily, well-tolerated dosing regimen with a compelling and competitive benefit-risk profile,” said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences.
“We recognize the significant need for new and innovative medicines to treat schizophrenia and look forward to advancing NBI-‘568, the first M4 selective agonist, into phase III development early next year,” she said. The trail has been dubbed as NBI-‘568.
24 million people
About 24 million people worldwide suffer from schizophrenia, according to the World Health Organization. It is a chronic and disabling mental health condition that is thought to result from a complex interplay of genetic and environmental risk factors.
People with schizophrenia are two to three times more likely to die early than the general population. This is often due to physical illnesses, such as cardiovascular, metabolic, and infectious diseases.
Traditional treatment approaches for schizophrenia rely on the use of antipsychotic medications that can lead to considerable short- and long-term health impacts.
NBI-‘568 was generally safe and well tolerated at all doses studied in the Phase 2 clinical trial, according to the statement.
Treatment discontinuation rates due to adverse events were similar between NBI-‘568 and placebo. Adverse events with the highest incidence were somnolence, dizziness, and headache.
Asset pipeline
Gastrointestinal adverse events including nausea and constipation were low in frequency and similar to placebo. Cardiovascular-related events were also low in frequency and were not deemed to have clinical relevance at any dose tested.
NBI-‘568 was not associated with a greater increase in weight than placebo.
In addition to NBI-‘568, Neurocrine Biosciences has a broad portfolio of assets in clinical development that selectively target muscarinic receptors.
Muscarinic receptors are central to brain function and validated as drug targets in psychosis and cognitive disorders.
No combination therapy
The company’s muscarinic agonist portfolio also includes NBI-1117567, NBI-1117569, and NBI-1117570, which the company acquired the rights to develop and commercialize from Nxera Pharma — formerly Sosei Heptares.
It is also developing NBI-1076986, a selective M4 antagonist that was discovered and is being developed internally at Neurocrine. Muscarinic receptors have five subtypes — M1 leading up to M5.
The M4 agonist, NBI-‘568 offers the potential for a mechanism with an improved safety profile without the need for combination therapy to minimize off-target pharmacology-related side effects.
