Neurocrine Biosciences to Pay Nxera Pharma $35M for Positive Phase 2 Schizophrenia Data

Nxera Pharma Co., Ltd. (TSE 4565), previously known as Sosei Group or Sosei Heptares, announced it will receive a payment of US$35 million from Neurocrine Biosciences. This payment is a result of the successful completion of the Phase 2 trial with the drug candidate NBI-1117568 (NBI-‘568) in adults suffering from schizophrenia. The announcement was made on 28 August 2024, and the payment will be recorded as one-time revenue in the third quarter of 2024.

The Phase 2 dose-finding study, referred to as NBI-’568-SCZ2028, met its primary endpoint with the 20 mg dose of NBI-‘568, showing that the drug was generally safe and well-tolerated across all doses tested. This success supports Neurocrine’s plans to move NBI-‘568 into Phase 3 clinical trials in early 2025. More detailed information on the positive Phase 2 data was provided by Nxera in a separate announcement dated 28 August 2024.

NBI-‘568 is an oral, muscarinic M4 selective agonist, currently the first of its kind being developed for the treatment of schizophrenia. It is the most advanced candidate from a broader portfolio of novel clinical and preclinical muscarinic M4, M1, and dual M1/M4 receptor agonists discovered by Nxera. These candidates are advancing under a global collaboration agreement established in 2021 with Neurocrine, aimed at treating major neurological and neuropsychiatric disorders.

Since the start of this collaboration, Nxera has received multiple significant payments from Neurocrine, including those tied to the developmental progress of four candidates currently in clinical trials. If all criteria under the agreement are met, Nxera stands to receive up to US$1.5 billion in development milestone payments through to approvals, in addition to commercial milestones that could total up to US$2.6 billion, plus product royalties. The company retains the rights to develop M1 agonists in Japan for various indications, subject to certain exceptions.

Matt Barnes, Executive Vice President and President of Nxera Pharma UK and Head of R&D, highlighted the positive outcome of the Phase 2 trial with NBI-‘568. He noted that the data supports the advancement of NBI-‘568 into Phase 3 trials, aiming to confirm its potential as a new oral therapeutic option for schizophrenia based on its efficacy, safety, and tolerability at a convenient once-daily 20mg dose.

Nxera Pharma and Neurocrine Biosciences initiated their collaboration and licensing agreement in November 2021, focusing on developing a portfolio of novel muscarinic receptor agonists for treating schizophrenia, dementia, and other neuropsychiatric disorders. Under this agreement, Neurocrine holds the development and commercialization rights to a broad range of novel clinical and preclinical subtype-selective muscarinic M4, M1, and dual M1/M4 receptor agonists discovered by Nxera. Neurocrine will handle the development costs globally, except for the M1 agonists being developed in Japan, where Nxera retains the rights for development in all indications, with certain exceptions. Neurocrine has options for co-development and profit-sharing.

Nxera is eligible for research and development funding, as well as development, regulatory, and commercial milestones totaling up to US$2.6 billion, in addition to product royalties, provided the conditions of the agreement are met.

Nxera Pharma, formerly Sosei Heptares, is a technology-driven biopharmaceutical company dedicated to developing new specialty medicines to address unmet medical needs in Japan and around the world. The company has a robust pipeline of over 30 active programs in various stages of development, from discovery to late clinical stages. These programs focus on areas such as neurology, gastroenterology, immunology, metabolic disorders, and rare diseases, leveraging its proprietary GPCR-targeted structure-based drug discovery platform, NxWaveTM, to generate best-in-class candidates. Nxera employs over 350 individuals across key locations including Tokyo, Osaka, London, Cambridge, Basel, and Seoul, and is publicly traded on the Tokyo Stock Exchange under the ticker symbol 4565.

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