Sosei Co. Ltd.

“Superluminal” refers to certain galaxies and other astrophysical phenomena that appear to move faster than the speed of light. Just over a year after launching with $33 million in seed funding, Boston-based Superluminal Medicines is supercharging its small-molecule drug development with a $120 million series A round backed by the likes of Eli Lilly.Superluminal focuses on G protein-coupled receptors (GPCRs), which are proteins embedded in the membranes of cells. Cells use membrane receptors to communicate with each other and detect changes to their environment. Thirty-five percent of all drugs target GPCRs, but 70% of the more than 800 GPCRs are currently undrugged, the biotech explained in a Sept. 9 release.RA Capital Management led the fundraise, joined by new investors Lilly, Catalio Capital Management and Cooley LLP, along with existing backers Insight Partners, Gaingels and NVIDIA’s VC arm NVentures. Superluminal will use the cash to advance its lead asset into the clinic.“We are advancing six small molecule programs and continue to build a discovery platform to quickly and efficiently generate therapeutics for any membrane drug target,” Superluminal CEO Cony D'Cruz said in a Sept. 9 release. Superluminal’s platform is designed to analyze the many forms that proteins can take, which D’Cruz said “is critical to identifying specific disease states mediated by membrane receptors.” The company aims to combine chemistry, machine learning and generative biology to identify new drugs rapidly, which explains its choice of name: “Superluminal” is a term used for certain galaxies and other astrophysical phenomena that appear to move faster than the speed of light.Several other companies are also vying for first place in the GPCR race. Septerna raised $150 million last year to take two GPCR drugs into the clinic and just two months later snagged $47.5 million upfront in a licensing deal with Vertex. Sosei Heptares struck a $27 million deal earlier this year with Boehringer Ingelheim for Sosei’s GPCR schizophrenia drug, while Tectonic Therapeutics merged with Avrobio in January and set GPCR drugs as the combined entity's primary target.

NBI-1117568 is an oral, muscarinic M4 selective receptor agonist discovered by Nxera advancing through clinical development under a multi-program collaboration with Neurocrine Biosciences The once-daily 20 mg dose efficacy, safety and tolerability Phase 2 results support advancement to Phase 3 in schizophrenia in early 2025 The once-daily 20 mg dose met the primary endpoint, demonstrating a statistically significant 7.5-point improvement (p=0.011, 0.61 effect size) in the PANSS total score compared to placebo at week 6 with an 18.2-point PANSS total score improvement from baseline The once-daily 20 mg dose met additional endpoints, demonstrating statistically significant improvements in Clinical Global Impression of Severity Scale and Marder Factor Score Positive Symptom Change and Negative Symptom Change NBI-’568 was generally safe and well tolerated at all doses studied Neurocrine to host conference call/webcast at 8am EDT / 1pm BST / 9pm JST 28 August 2024 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) – formerly known as Sosei Group or Sosei Heptares – notes the announcement by its partner Neurocrine Biosciences Inc. (“Neurocrine”; Nasdaq: NBIX) that NBI-1117568 (NBI-‘568) has delivered positive topline results from its Phase 2 clinical study in adults with schizophrenia. NBI-’568 is the first investigational, oral, muscarinic M4 selective agonist in development for the treatment of schizophrenia. NBI-‘568 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 a 2021 global collaboration with Neurocrine for the treatment of major neurological disorders. To date, Nxera has received multiple, significant payments from Neurocrine including those based on developmental progress of four candidates in clinical trials and is eligible to receive development, regulatory and commercial milestones of up to US$2.6 billion, plus product royalties, provided the criteria under the agreement are satisfied. Nxera retains rights to develop M1 agonists advancing under this collaboration in Japan in all indications, subject to certain exceptions. The NBI-’568-SCZ2028 dose-finding study met its primary endpoint for the once-daily 20 mg dose. It demonstrated a clinically meaningful and statistically significant reduction from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 6 with a placebo-adjusted mean reduction of 7.5 points (p=0.011 and effect size of 0.61) and an 18.2-point reduction from baseline. The once-daily 20 mg dose also demonstrated a statistically significant improvement for additional endpoints, including improvement in the Clinical Global Impression of Severity (CGI-S) scale, Marder Factor Score – Positive Symptom Change, and Marder Factor Score – Negative Symptom Change. Matt Barnes, EVP, President of Nxera Pharma UK and Head of R&D, commented: “These Phase 2 data reported by our partner Neurocrine represent an important milestone and strong clinical validation of the power of Nxera’s NxWave™ discovery platform. We believe these data show that NBI-1117568 has a competitive product profile and could be an important new therapy option for patients with schizophrenia potentially with a once-daily pill. Furthermore, with four development candidates in clinical trials from the portfolio of selective muscarinic agonists discovered and licensed by Nxera to Neurocrine in 2021, offering multiple shots on goal across complex neurological and neuropsychiatric disorders, we look forward to further progress under this highly productive partnership.” “This Phase 2 dose-finding study delivered on our goal of identifying a once-daily, well tolerated dosing regimen with a compelling and competitive benefit-risk profile,” said Eiry Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. “We recognize the significant need for new and innovative medicines to treat schizophrenia and look forward to advancing NBI-’568, the first M4 selective agonist, into Phase 3 development early next year.” NBI-’568 was generally safe and well-tolerated at all doses studied in the Phase 2 clinical trial. Treatment discontinuation rates due to adverse events were similar between NBI-’568 and placebo. Adverse events with the highest incidence were somnolence, dizziness, and headache. Gastrointestinal adverse events including nausea and constipation were low in frequency and similar to placebo. Cardiovascular-related events were also low in frequency and were not deemed to have clinical relevance at any dose tested. NBI-’568 was not associated with a greater increase in weight than placebo. Few extrapyramidal symptoms adverse events were reported. Primary Endpoints Results Summary *Least-squares (LS) means are from a mixed models for repeated measures (MMRM), which includes treatment group, visit, and study period as fixed effects; treatment group-by-visit interaction; baseline PANSS total score as a covariate; and subject as a random effect. **Effect size (Cohen’s D) is based on observed data. Status of Neurocrine’s Muscarinic Portfolio Licensed from Nxera Neurocrine is advancing an industry leading portfolio of muscarinic agonists in clinical development with potential to treat a range of neurological and neuropsychiatric conditions. The four candidates progressing from its partnership with Nxera, are: *Nxera retains rights to develop M1 agonists advancing under this collaboration in Japan in all indications, subject to certain exceptions. NBI-1117568 is the first and only M4 selective orthosteric agonist in clinical development. It was discovered by Nxera Pharma and licensed to Neurocrine in 2021 as part of a portfolio of muscarinic receptor agonists with potential to treat a range of neurological and neuropsychiatric conditions. There are five muscarinic acetylcholine receptors involved in neurotransmission. As an M4 selective agonist, NBI-1117568 offers the potential for an improved safety profile without the need of combination therapy to minimize off-target pharmacology-related side effects, while also not being dependent on the presence of acetylcholine for efficacy. The Phase 2, multicenter, randomized, double-blind, placebo-controlled, multi-arm, multi-stage inpatient dose-finding study was designed and conducted by Neurocrine to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of NBI-’568 compared with placebo in adult subjects with a primary diagnosis of schizophrenia who are experiencing an acute exacerbation or relapse of symptoms. The study enrolled 210 participants. For more information about this study, visit ClinicalTrials.gov. Nxera Pharma and Neurocrine entered a collaboration and licensing agreement in November 2021 to develop a portfolio of novel muscarinic receptor agonists for the treatment of schizophrenia, dementia and other neuropsychiatric disorders. Under the terms of the agreement, Neurocrine gained 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. Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. Neurocrine Biosciences is dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington’s disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across its core therapeutic areas. For three decades, Neurocrine Biosciences has applied its unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. The company relentlessly pursues medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter), and Facebook. 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). The content above comes from the network. if any infringement, please contact us to modify.

PIVLAZ™ is the first drug approved in South Korea for the prevention of Cerebral Vasospasm in patients with Aneurysmal Subarachnoid Hemorrhage (aSAH) PIVLAZ™ will become commercially available in South Korea in early 2025 15 April 2024 – Nxera Pharma Co. Ltd (“Nxera” or “the Company; TSE 4565) – formerly known as Sosei Group or Sosei Heptares – today announces that its operating business Nxera Pharma Korea (“NPK”) has entered into an exclusive supply and distribution agreement with Handok Inc. (“Handok”) to commercialize PIVLAZ™ (clazosentan sodium) 150 mg in South Korea. Under the terms of the agreement, NPK will provide drug product to Handok at an agreed price and Handok is exclusively responsible for the promotion, marketing, sales and distribution of PIVLAZ™ in South Korea. Nxera will receive a one-off upfront payment from Handok upon signing of the agreement and is eligible for further commercial milestone payments plus sales coming from product supply. Handok is a leading innovation-driven pharmaceutical/healthcare company in South Korea. Handok has been a pioneer in the Korean pharmaceutical industry by introducing new products to the Korean market through partnerships, internal R&D, and state-of-the-art manufacturing while maintaining a global standard compliance program. PIVLAZ™ is approved in South Korea for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction, and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH). Satoshi Tanaka, Dr Med Sci., Executive Officer and Executive Vice President of Nxera, Chairman of NPK, added: “We are pleased to be continuing our long-standing partnership with Handok to bring PIVLAZ™ to patients in South Korea. PIVLAZ™ represents a potentially life-changing treatment option for patients and Handok’s wealth of expertise and history of delivering products to the Korean market makes them the ideal partner. With this partnership in place, we are confident that we will be able to deliver PIVLAZ™ to physicians and patients in South Korea in early 2025.” 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). The content above comes from the network. if any infringement, please contact us to modify.