Nxera Pharma, a Japanese biopharmaceutical company, has secured a $35 million milestone payment from Neurocrine Biosciences following the success of its Phase II clinical trial of NBI-1117568 (NBI-568) in adult patients with schizophrenia. The collaboration, established in November 2021, focuses on developing novel muscarinic receptor antagonists, potentially earning Nxera up to $2.6 billion plus royalties.
The Phase II dose-finding study demonstrated that NBI-568 met its primary endpoint, achieving a statistically significant reduction in schizophrenia symptoms with a once-daily 20mg dose. The trial also showed a clinically meaningful and statistically significant decline in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to week six.
Addressing Unmet Needs in Schizophrenia Treatment
The current schizophrenia treatment landscape is largely based on dopamine-blocking antipsychotics, which are often associated with significant side effects such as Parkinsonian symptoms, sexual dysfunction, and weight gain. There is a growing need for new medications that can effectively target both the positive and negative symptoms of schizophrenia.
Positive symptoms include hallucinations and delusions, while negative symptoms encompass a lack of interest in social interactions, low mood, and withdrawal from normal life. NBI-568, as an oral, muscarinic M4 selective agonist, represents a novel approach by influencing dopamine signaling to alleviate both symptom types.
NBI-568: A Potential New Therapy
NBI-568 is designed as an oral muscarinic M4 selective agonist. It is believed to mitigate both positive and negative symptoms of schizophrenia through its influence on dopamine signaling pathways. Neurocrine Biosciences intends to advance NBI-568 into Phase III clinical trials in early 2025. GlobalData forecasts predict potential sales of up to $202 million by 2030 if the drug receives approval.
Expert Commentary
Nxera’s UK president and R&D head, Matt Barnes, stated, “The successful Phase II trial with NBI-568 delivered positive data in adults with schizophrenia at the 20mg dose… As stated by Neurocrine, these data support advancing NBI-568 into Phase III trials that would aim to confirm its potential to become a new oral therapy option for patients with a competitive profile based on efficacy, safety, and tolerability from a convenient 20mg once-daily administration.”
Competition in the Schizophrenia Treatment Space
All eyes are also on Bristol Myers Squibb’s (BMS’s) KarXT, awaiting potential FDA approval, with a Prescription Drug User Fee Act (PDUFA) date set for September 26, 2024. If approved, KarXT would introduce a new class of medication for schizophrenia treatment.
