Japanese biopharma Nxera Pharma has secured $35m in milestone payments from Neurocrine Biosciences following positive Phase II trial data of NBI-1117568 (NBI-568) in adults with schizophrenia.
The two companies teamed up in November 2021 to develop novel muscarinic receptor antagonists. Nxera – which has a portfolio of muscarinic receptor agonists – could secure up to $2.6bn in total from its partnership with Neurocrine, along with product royalties.
Neurocrine reported positive data from the Phase II dose-finding study last week, highlighting that the study met its primary endpoint with a significant reduction in schizophrenia symptoms at a once-daily 20mg dose. The trial also demonstrated a clinically meaningful and statistically significant decline in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to week six.
The current treatment landscape for schizophrenia is dominated by dopamine-blocking antipsychotics, which have significant side effects such as Parkinsonian symptoms, sexual dysfunction, and weight gain. There has been a push in the space for a new class of medication, that can target both the positive and negative symptoms of schizophrenia.
The positive symptoms refer to any change in behaviour or thoughts, such as hallucinations or delusions. Negative symptoms include a lack of interest in everyday social interactions, low mood, and the appearance of withdrawal from normal life.
NBI-568 is an oral, muscarinic M4 selective agonist. It is thought to alleviate both positive and negative symptoms of schizophrenia by influencing dopamine signalling. Neurocrine now plans to advance the candidate into Phase III clinical trials in early 2025. According to GlobalData forecasters, NBI-568 could generate up to $202m in sales in 2030 if it secured approval.
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Elsewhere in the space, all eyes move to Bristol Myers Squibb’s (BMS’) KarXT as potential US Food and Drug Administration (FDA) approval looms. The Prescription Drug User Fee Act (PDUFA) date for KarXT is 26 September 2024. If approved, the drug would represent a new class of medication on offer to those with schizophrenia.
In the announcement accompanying the payment, Nxera’s UK president and R&D head Matt Barnes said: “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.”
