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Nxera Pharma Notes Successful Development Progress of Partnered Schizophrenia Candidate NBI-1117568 | ||
By: GlobeNewswire - 16 Apr 2024 | Back to overview list |
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Tokyo, Japan and Cambridge, UK, 16 April 2024 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company; TSE 4565) – formerly known as Sosei Group or Sosei Heptares – has been notified by its partner Neurocrine Biosciences Inc. (“Neurocrine”; Nasdaq: NBIX) that NBI-1117568, an oral selective muscarinic M4 receptor agonist being advanced in Phase 2 clinical trials by Neurocrine for the treatment of schizophrenia and other neuropsychiatric disorders, has successfully completed a long-term preclinical toxicity program that meets US FDA requirements to allow for safe, chronic (i.e. long-term) dosing in future clinical trials. The achievement of this important safety development milestone triggers a $15 million payment to Nxera from Neurocrine. NBI-1117568 is the most advanced candidate from a broad portfolio of novel clinical and preclinical subtype-selective muscarinic M4, M1 and dual M1/M4 receptor agonists discovered by Nxera and advancing under the 2021 global collaboration with Neurocrine for the treatment of major neurological disorders. These candidates have potential to address a range of neurological and neuropsychiatric conditions and include:
Matt Barnes, EVP, President of Nxera Pharma UK and Head of R&D, commented: “We are delighted that NBI-1117568 has successfully achieved this important safety development milestone. These results will support the safe, long-term use of this novel clinical candidate, which is consistent with a desired product profile for schizophrenia and other neurological diseases where patients often need therapy over many years. We are extremely pleased at the progress being made under our highly productive partnership with Neurocrine and look forward to reporting further progress and upcoming clinical data readouts, including the top-line Phase 2 data on NBI-1117568, which is expected in the second half of 2024.” *Nxera retains rights to develop M1 agonists advancing under this collaboration in Japan in all indications. –END– About Muscarinic Receptors Until now, attempts to develop medicines that selectively target M4 and M1 receptors have been unsuccessful because of side effects caused by the activation of M2 and M3 receptors. Highly selective M4 or M1 agonists that do not activate M2 or M3 therefore are highly sought after and expected to have the potential to address major unmet medical needs with blockbuster potential. About NBI-1117568 About the Agreement with Neurocrine Biosciences Under the terms of the agreement, Neurocrine gains development and commercialization rights to a broad portfolio of novel clinical and preclinical subtype-selective muscarinic M4, M1 and dual M1/M4 receptor agonists discovered by Nxera. Neurocrine is responsible for development costs associated with the programs globally, except for M1 agonists being developed in Japan. Nxera retains rights to develop M1 agonists in Japan for any indication, with Neurocrine receiving co-development and profit share options. Nxera is eligible to receive R&D funding plus development, regulatory and commercial milestones of up to US$2.6 billion, with further product royalties, provided the criteria under the agreement are satisfied. About Neurocrine Biosciences NEUROCRINE BIOSCIENCES, NEUROCRINE, and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc. The Neurocrine logo is a trademark of Neurocrine Biosciences, Inc. About Nxera Pharma In addition to several products being commercialized in Japan, we are advancing an extensive pipeline of over 30 active programs from discovery through to late clinical stage internally and in partnership with leading pharma and biotech companies. This pipeline is focused on addressing major unmet needs in some of the fastest-growing areas of medicine across neurology, GI and immunology, metabolic disorders and rare diseases, and leverages the power of our unique and industry leading GPCR-targeted structure-based drug discovery “NxWaveTM” platform to provide a sustainable source of best- or first-in-class candidates. Nxera employs over 350 talented people 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 Enquiries: Nxera – Media and Investor Relations MEDiSTRAVA Consulting (for International Media) Forward-looking statements |
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