Nxera Pharma's Partner Neurocrine Biosciences Doses First Patient in Phase 2 Trial of NBI-1117570 for Adults with Schizophrenia
MWN-AI** Summary
Nxera Pharma Co., Ltd. (TSE: 4565) has announced a significant milestone as its partner Neurocrine Biosciences Inc. has dosed the first patient in a Phase 2 clinical trial of the investigational drug NBI-1117570 (NBI-‘570) aimed at treating adults with schizophrenia. This Phase 2 study is a double-blind, placebo-controlled trial designed to evaluate NBI-‘570’s efficacy, safety, and tolerability, with an expected enrollment of approximately 120 patients. The primary endpoint is the change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score, while treatment-emergent adverse events (TEAEs) will serve as a key secondary endpoint.
NBI-‘570 is an oral dual muscarinic M1/M4 receptor agonist, discovered through Nxera's proprietary NxWave™ drug discovery platform. The initiation of this study not only marks the advancement of a second NxWave™-designed compound into Phase 2 but also triggers milestone payments of USD 22.5 million for Nxera, expected to be recognized as revenue in Q1 FY2026.
The ongoing collaboration between Nxera and Neurocrine highlights the growing focus on addressing the underserved medical needs associated with schizophrenia, a complex disorder impacting approximately 24 million people globally and resulting in significant emotional and functional burdens. Traditional treatments often involve antipsychotic medications, which can have substantial health impacts.
Christopher Cargill, President and CEO of Nxera, expressed optimism regarding the potential of NBI-‘570 to improve patient outcomes in this area. As the company advances its pipeline of specialty medicines, it continues to operate with a focus on innovation, aiming to bring meaningful treatments to the market for patients with unmet needs globally.
MWN-AI** Analysis
Investors in Nxera Pharma (TSE: 4565) should closely monitor developments following their partner Neurocrine Biosciences’ recent initiation of a Phase 2 trial for NBI-1117570, an investigational treatment for schizophrenia. This milestone marks a significant advancement in Nxera’s collaboration with Neurocrine, signaling confidence in the potential of their proprietary NxWave™ drug discovery platform.
The announcement reveals that Nxera will receive $22.5 million in milestone payments, which will bolster revenues in Q1 FY2026. Given schizophrenia's substantial unmet medical need, the success of NBI-1117570 could not only serve as a vital addition to treatment options but could also significantly enhance Nxera's market position and financial prospects.
Phase 2 studies are crucial as they often define a drug's efficacy and tolerability. The trial, focusing on approximately 120 adult in-patients, will supply essential data with the primary endpoint being the change in the Positive and Negative Syndrome Scale (PANSS) score. A favorable outcome could lead to accelerated development, attracting further investment and potentially increasing stock value.
Moreover, with the annual costs of schizophrenia treatment exceeding $150 billion in the U.S. alone, successful market entry for NBI-1117570 could result in substantial revenue streams for both Nxera and Neurocrine. The dual action on muscarinic receptors M1 and M4, targets linked to cognition and psychosis, elevates the drug's potential profile, attracting both patients and providers.
That said, investors must remain cognizant of the unpredictable nature of clinical trials. While the current trajectory appears promising, market volatility may affect share prices during ongoing trials. As a recommendation, maintaining a diversified portfolio while keeping an eye on Nxera's updates and trial results may be a prudent strategy amidst the excitement surrounding their pipeline advancements.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
- NBI-1117570 is an investigational oral, dual muscarinic M1/M4 selective receptor agonist discovered by Nxera advancing through clinical development under a multi-program collaboration with Neurocrine
- Nxera to receive US$22.5 million in milestone payments from Neurocrine
Tokyo, Japan and Cambridge, UK, 13 April 2026 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) today announces that its partner Neurocrine Biosciences Inc. (“Neurocrine”) has initiated and dosed the first patient(s) in a Phase 2 clinical study of NBI-1117570 (“NBI-’570”) in adults with schizophrenia. As a result, Nxera will receive milestone payments of US$22.5 million from Neurocrine pursuant to the agreement. The milestone payments will be recognised as revenue in Q1 FY2026. NBI-‘570 is an investigational, orally administered, dual muscarinic M1/M4 receptor agonist discovered using Nxera’s proprietary NxWave™ drug discovery platform.
Christopher Cargill, President and CEO of Nxera Pharma, commented: “The initiation of this Phase 2 study with NBI-‘570, the second NxWave™-designed compound in Neurocrine’s muscarinic agonist portfolio to advance into Phase 2 clinical trials, represents another important step forward in our highly productive collaboration. Schizophrenia remains an area of significant unmet medical need and we believe NBI-’570 has the potential to contribute meaningfully to improving outcomes for patients. We look forward to sharing further updates on progress across the muscarinic agonist portfolio.”
The Phase 2 study (NCT07288333) is a double-blind, placebo-controlled trial designed to evaluate the efficacy, safety and tolerability of NBI-‘570 in adult patients with schizophrenia requiring in-patient treatment. The study is expected to enroll approximately 120 patients. The primary endpoint is change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score, and the key secondary endpoint is treatment-emergent adverse events (TEAEs).
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About NBI-1117570
NBI-1117570 is an investigational, oral, dual muscarinic M1/M4 agonist. Muscarinic receptors are fundamental to activating signaling pathways in the brain. There are five muscarinic acetylcholine receptors involved in neurotransmission, two of which are selectively targeted by NBI-‘570 (M1 and M4), with M1 clinically validated as a potential drug target in cognition and M4 in psychosis. Neurocrine Biosciences acquired the rights to develop and commercialize NBI-‘570 from Nxera Pharma.
About Schizophrenia
Schizophrenia is a serious and complex syndrome with heterogeneous symptoms. The World Health Organization estimates that the disorder impacts approximately 24 million people worldwide. Annual associated costs for schizophrenia are estimated to be more than $150 billion in the United States. As one of the leading causes of disability worldwide, it often results in significant emotional and functional burden for those who experience symptoms, as well as their family and friends. This chronic and disabling mental health condition is thought to result from a complex interplay of genetic and environmental risk factors. Traditional treatment approaches for schizophrenia rely on the use of antipsychotic medications that can lead to considerable short- and long-term health impacts.
About Nxera Pharma
Nxera Pharma is a technology powered biopharma company in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally. The Company has built an agile, new-generation commercial business in Japan to develop and commercialize innovative medicines, including several launched products, to address this high-value, large and growing market and those in the broader APAC region. In addition, the Company is advancing an extensive pipeline internally and in partnership with leading pharma and biotech companies powered by its unique NxWave™ GPCR structure-based drug discovery platform. Nxera Pharma operates at key locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland) and Seoul (South Korea) and is listed on the Tokyo Stock Exchange (ticker: 4565).
For more information, please visit www.nxera.life
LinkedIn: @NxeraPharma | X: @NxeraPharma | YouTube: @NxeraPharma
Enquiries:
Nxera – Media and Investor Relations
Shinya Tsuzuki, VP, Head of Investor Relations
Maya Bennison, Communications Manager
+81 (0)3 5210 3399 | +44 (0)1223 949390 |IR@Nxera.life
MEDiSTRAVA (for International Media)
Mark Swallow, Frazer Hall, Erica Hollingsworth
+44 (0)203 928 6900 | Nxera@medistrava.com
Forward-looking statements
This press release contains forward-looking statements, including statements about the discovery, development, and commercialization of products. Various risks may cause Nxera Pharma Group’s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in clinical development programs; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
FAQ**
How do you anticipate the Phase 2 clinical trial for NBI-1117570, developed by Nxera Pharma Co Ltd Ord SOLTF, will impact its market potential and competitive positioning in treating schizophrenia?
What milestones and timelines should investors expect regarding the clinical development progress of NBI-1117570 under Nxera Pharma Co Ltd Ord SOLTF's collaboration with Neurocrine Biosciences?
What are the expected financial implications for Nxera Pharma Co Ltd Ord SOLTF upon receiving the US$22.5 million milestone payments from Neurocrine, especially concerning cash flow and future R&D investments?
How significant is the dual M1/M4 receptor targeting mechanism of NBI-1117570 for Nxera Pharma Co Ltd Ord SOLTF in addressing the identified unmet medical needs in schizophrenia, and what are the potential market opportunities?
**MWN-AI FAQ is based on asking OpenAI questions about Nxera Pharma Co Ltd Ord (OTC: SOLTF).
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