Nxera Secures $35M After Phase II Schizophrenia Trial Success

Nxera Pharma, a Japanese biotechnology firm, has received $35 million in milestone payments from Neurocrine Biosciences. This payment follows the positive results from a Phase II clinical trial of their drug NBI-1117568 (NBI-568) in adults with schizophrenia. The two companies began their collaboration in November 2021 to develop new muscarinic receptor antagonists. Nxera, which specializes in muscarinic receptor agonists, could potentially secure up to $2.6 billion from this partnership, in addition to product royalties.

Recently, Neurocrine disclosed the positive outcomes of the Phase II dose-finding study. The study achieved its primary objective by significantly reducing symptoms of schizophrenia at a daily dose of 20mg. Moreover, the trial showed a clinically meaningful and statistically significant reduction in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to the sixth week.

The current treatment options for schizophrenia are primarily dopamine-blocking antipsychotics, which come with substantial side effects such as Parkinsonian symptoms, sexual dysfunction, and weight gain. There is a substantial need for a new class of medication that can address both the positive and negative symptoms of schizophrenia. Positive symptoms involve changes in behavior or thoughts, like hallucinations or delusions, while negative symptoms include lack of interest in social interactions, low mood, and withdrawal from daily life.

NBI-568 is an oral, muscarinic M4 selective agonist. It is believed to alleviate both positive and negative symptoms of schizophrenia by affecting dopamine signaling pathways. Neurocrine now plans to advance NBI-568 to Phase III clinical trials in early 2025. According to forecasts from GlobalData, NBI-568 could generate up to $202 million in sales by 2030 if it gains approval.

On another front, attention is also focused on Bristol Myers Squibb’s KarXT, as it awaits potential approval from the US Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) date for KarXT is set for September 26, 2024. If approved, KarXT would represent a new class of medication for schizophrenia patients.

In a statement accompanying the announcement of the milestone payment, Nxera’s UK president and head of R&D, Matt Barnes, expressed optimism about the future of NBI-568. He 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."

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