Sosei to Advance Clinical Development in Japan of HTL0018318 in Patients with Dementia with Lewy Bodies (DLB)
Sosei Group Corporation (“Sosei”); TSE Mothers Index:4565) announces that it has agreed with Allergan to an amendment to the 2016 global R&D and commercialisation partnership between Allergan and Sosei’s subsidiary Heptares Therapeutics, in which Allergan gained exclusive rights to Heptares’ broad portfolio of novel subtype-selective muscarinic receptor agonists in development for the treatment of major neurological disorders, including Alzheimer’s disease (AD).
This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171108006751/en/
The amendment sees Sosei gain a licence to develop and commercialise HTL0018318, a novel muscarinic M1 receptor agonist, in Japan as a potential new treatment for patients with dementia with Lewy bodies (DLB). Initially, Sosei will undertake a Phase 2 proof-of-concept monotherapy study, expected to begin in Japan in 2018. Allergan has retained the right to develop HTL0018318 in DLB globally.
DLB is the second most common form of degenerative dementia after AD and relates to dementia associated with the presence of Lewy bodies (abnormal deposits of a protein called alpha-synuclein) in the brain that affect behaviour, cognition and movement. In DLB, loss of presynaptic cholinergic (acetylcholine-producing) neurons is thought to be a key driver of disease symptoms. As in AD, postsynaptic neurons and muscarinic receptors in DLB are preserved, which presents an important opportunity for a selective M1 agonist based approach.
DLB affects up to an estimated 20-30% of all dementia patients. In Japan, this represents approximately 920,000 individuals, and in the US approximately 1.4 million individuals. There are no approved therapies for DLB in the US or Europe, while branded donepezil (Aricept®, Eisai) is conditionally approved in Japan.
Commenting on the announcement, Peter Bains, CEO at Sosei, said: “This is a very exciting development in our partnership with Allergan. It provides Sosei with a major go-to-market opportunity for our lead program, which is consistent with our growth strategy. Sosei has developed an extensive understanding of the DLB opportunity in Japan, and alongside our clinical development capabilities and track record of successful product development in Japan we believe we can add significant value to the M1 agonist program overall through this activity.”
Notes to Editors
About Muscarinic receptors
Muscarinic receptors are G protein-coupled receptors (GPCRs) found in multiple tissues. Until now, attempts to develop medicines that target M1 and M4 receptors have been unsuccessful because of side effects caused by the activation of M2 and M3 receptors. Selective M1 or M4 agonists that do not activate M2 or M3 therefore are highly sought after, and expected to address blockbuster markets.
About the Heptares Therapeutics and Allergan Partnership
Heptares Therapeutics and Allergan entered a global R&D and commercialisation partnership in April 2016 under which Allergan licensed exclusive global rights to Heptares’ broad portfolio of novel subtype-selective muscarinic receptor agonists (M1, M4 and dual M1/M4 agonists) in development for the treatment of major neurological disorders, including Alzheimer’s disease.
The companies are advancing a program evaluating a selective M1 agonist (HTL0018318) through clinical studies as a potential treatment for symptomatic cognitive deficits in Alzheimer’s patients; a clinical program to assess the potential of a selective M4 agonist (HTL0016878) to treat certain neurobehavioural symptoms of Alzheimer’s disease; and are developing dual M1/M4 agonists with potential to treat both cognitive and neurobehavioural symptoms through preclinical studies.
In addition, Sosei plans to initiate a Phase 2 clinical study with HTL0018318 in patients with dementia with Lewy bodies in Japan.
Sosei Group Corporation is an international biopharmaceutical company originating from Japan that discovers and develops innovative biopharmaceuticals for the treatment of Alzheimer's disease, schizophrenia, cancer, migraine, addiction, metabolic disease, and other indications. By utilizing its GPCR structure-based drug design platform technology, Sosei has established a product pipeline with first/best in class potential. Through development and commercialization partnerships, Sosei has already delivered two bronchodilators for COPD which generate significant and stable revenue streams that enable further growth. Sosei partners include Novartis, Allergan, AstraZeneca, MedImmune, MorphoSys, Teva, and Pfizer and we are actively looking for new partnerships to enhance the development of our products and help us deliver them to patients worldwide.
For further information about Sosei, please visit http://www.sosei.com/en/.
Sosei Group Corporate Forward-looking statements
This press release contains forward-looking statements, including statements about the discovery, development and commercialisation of products. Various risks may cause Sosei’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 commercialise 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 commercialisation 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.
Sosei Group Corporation
Chris Cargill, +44 (0)7912 892 199
Head of Investor Relations and Corporate Communications
Harumi Banse, +81-(0)3-5210-3399
Investor Relations and Corporate Communications (Japan)
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
A Better Way to Earn Interest on Digital Assets18.1.2019 01:00 | Pressemelding
Cred, the leading provider of crypto borrowing and lending with over $300 million in credit facilities, today announced the launch of CredEarn* on the Uphold platform. CredEarn allows Uphold customers to lend their crypto and fiat assets to Cred and receive up to 10% of annualized interest. “We’re thrilled to offer consumers the opportunity to earn interest on their digital assets and fiat currencies,” said Dan Schatt, Co-founder and President of Cred. “In a bear market, customers can benefit from the liquidity they receive when obtaining a fixed amount of interest in USD or Stablecoin. In a bull market, customers also benefit by receiving the full upside on the amount of crypto they originally committed.” CredEarn customers can commit to a six-month term with the ability to rollover assets for additional periods. No account minimum is needed and interest is paid out in U.S. Dollars or Stablecoin every three months on Uphold. The principal is paid back in the fiat or crypto amounts tha
Servier and Taiho Oncology Present Latest LONSURF® (trifluridine/tipiracil) Data at ASCO 2019 Gastrointestinal Cancers Symposium (ASCO GI)17.1.2019 23:45 | Pressemelding
Servier and Taiho Oncology, Inc. (U.S.), a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), jointly announced today that the safety and efficacy data in the gastrectomy patient subgroup of the global Phase III trial TAGS evaluating LONSURF® (trifluridine/tipiracil, TAS-102) in patients with metastatic gastric cancer (mGC) are consistent with the overall study results published in The Lancet Oncology. These data were highlighted in an oral presentation at the ASCO 2019 Gastrointestinal Cancers Symposium (ASCO-GI) on Thursday 17 January. In TAGS, 221 (44%) of the 507 randomized mGC patients had undergone prior gastrectomy (147 LONSURF, 74 placebo), which is reflective of the real-world patient population diagnosed with mGC. The results confirmed that trifluridine/tipiracil prolonged survival versus placebo regardless of prior gastrectomy. The overall results of TAGS demonstrated that patients treated with oral trifluridine/tipiracil showed a clinically meaningful and statistically s
ISACA Announces 2019 Slate of Events for Business Technology Professionals Around the Globe During its 50th Anniversary Year17.1.2019 19:24 | Pressemelding
ISACA, a global association serving technology audit, assurance, governance and cybersecurity professionals, celebrating its 50th anniversary in 2019, announced its annual event schedule, which includes learning opportunities focused on emerging technologies, innovation, best practices and professional development. Disruptive technologies over the last 50 years and in the future of business enterprise, and the evolution of technology careers and ISACA professions, will be featured in conjunction with the ISACA anniversary year at nearly every venue. ISACA’s growing Cybersecurity Solution Portfolio, including the CSX Training Platform and the CMMI Cybermaturity Platform, will be highlighted in new conferences in 2019, which will include events in North America and Europe. The 2019 CACS conferences, set for North America, Europe, Asia, Africa, the Oceania region and Latin America, will offer educational sessions in audit and assurance, big data, risk management, governance and more. All
HighLife Closes a €32 Million Round B Financing17.1.2019 17:25 | Pressemelding
HighLife SAS, a medtech company focused on the development of a unique transcatheter mitral valve replacement (“TMVR”) system to treat patients suffering from mitral regurgitation, announced today it had closed a €32 million round of equity financing. Proceeds from the financing will be used to complete the development of the company’s transcatheter transseptal mitral valve implantation program, which includes regulatory approval trials in Europe to obtain the CE mark and a first clinical trial in the U.S. via an Early Feasibility Study (EFS). The Series B round was co-led by U.S. Venture Partners (“USVP”) and Andera Partners, with Sectoral Asset Management and Jose Calle Gordo, Chairman of the company, joining the round. Sofinnova Partners, which led the Series A round, continues to support the company and participated in this latest round of financing. Bryan Garnier & Co (Paris) acted as private placement agent for this financing. “I am very pleased to announce the closing of the Ser
The Brightline™ Initiative, led by Project Management Institute, to Support The Economist Davos Panel17.1.2019 15:00 | Pressemelding
The Brightline™ Initiative, a coalition dedicated to helping executives bridge the gap between strategy design and delivery, along with Project Management Institute is hosting The Economist Events panel discussion entitled “Humans 2.0: Designing and Implementing a Future Proof Strategy.” In line with Davos’ overarching theme, “Globalization 4.0: Shaping a Global Architecture in the Age of the Fourth Industrial Revolution,” panelists will discuss how business leaders can harness the power of people to adapt and implement corporate strategies and grapple with the effects of disruptive technologies. This topic is of particular interest to PMI, the leading member of Brightline, given how this wave of disruption calls for organizations to rely on successful implementation of new strategies at unprecedented scope and speed to meet market demands. “As a coalition committed to moving from idea to strategy implementation to results, we’re delighted to partner with The Economist Events to bring
MSCI Schedules Investor Conference Call to Review Fourth Quarter and Full Year 2018 Results17.1.2019 14:00 | Pressemelding
MSCI Inc. (NYSE:MSCI), a leading provider of indexes and portfolio construction and risk management tools and services for global investors, today announced it will release its results for the fourth quarter and full year 2018 on Thursday, January 31, 2019. MSCI's senior management will review the fourth quarter and full year 2018 results on Thursday, January 31, 2019 at 11:00 AM Eastern Time. To listen to the live event, visit the events and presentations section of MSCI's Investor Relations homepage, http://ir.msci.com/events.cfm, or dial 1-877-376-9931 conference ID: 3474708 within the United States. International callers dial 1-720-405-2251 conference ID: 3474708. The earnings release and related investor presentation used during the conference call will be made available on MSCI's Investor Relations homepage. An audio recording of the conference call will be available on our Investor Relations website, http://ir.msci.com/events.cfm, beginning approximately two hours after the conc