Nxera Pharma and Neurocrine Biosciences Complete Preclinical Toxicity Program in Schizophrenia Drug Hopeful
Nxera Pharma (OTC: SOLTF) and Neurocrine Biosciences (Nasdaq: NBIX) have successfully completed a long-term preclinical toxicity program for NBI-1117568, which is in Phase 2 clinical trials for the treatment of schizophrenia and other neuropsychiatric disorders. The studies have shown that NBI-1117568 meets FDA requirements to allow for safe, long term dosing in future clinical trials. The successful completion of this milestone triggers a $15 million payment to Nxera from Neurocrine.
Commenting on the news, Matt Barnes, EVP, President of Nxera Pharma UK and Head of R&D, said, “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 Pharma and Neurocrine BioSciences entered a collaboration and licensing agreement in November 2021. 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 Nxera Pharma
Nxera Pharma (formerly Sosei Heptares) 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.
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 LinkedIn: @NxeraPharma | X: @NxeraPharma | YouTube: @NxeraPharma
