Takeda to Present Additional Clinical Trial Study Data Highlighting the Impact of Orexin Agonist TAK-861 on the Burden of Narcolepsy at Sleep Europe 2024

− Presentations Include New Data from the TAK-861-2001 Phase 2b Trial in Narcolepsy Type 1 Highlighting Impact on Daily Functioning Including Cognition and Sleep Quality

− Data from Long-Term Extension Study will also be Presented

− Phase 3 Trial of an Orexin Agonist for Narcolepsy Type 1 Now Enrolling Patients Globally

Takeda (TSE:4502/NYSE:TAK) will present additional data from the Phase 2b trials (TAK-861-2001,TAK-861-2002) and long-term extension (LTE) study (TAK-861-2003) of TAK-861 in narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2) at Sleep Europe 2024, the 27^th Congress of the European Sleep Research Society (ESRS), being held September 24-27, 2024 in Seville, Spain. TAK-861 is an investigational oral orexin receptor 2 (OX2R) selective-agonist designed to address the orexin deficiency in NT1 by selectively stimulating the orexin receptor 2. TAK-861 has the potential to be the first treatment to address the underlying pathophysiology of NT1. Based on the positive Phase 2b trial results, Takeda has initiated the FirstLight Study, a global Phase 3 trial evaluating the efficacy and safety of TAK-861 in adults with NT1.

Takeda’s scientific presentations will include a podium presentation highlighting the effect of TAK-861 on cognitive impairment (Abstract No: 781) along with several poster presentations from additional exploratory endpoints including impacts on quality of nocturnal sleep and sustained attention. An interim analysis of safety and efficacy from the ongoing LTE study (Poster No: P1291) will also be presented.

“People living with narcolepsy suffer from debilitating symptoms that significantly impact their daily life beyond excessive daytime sleepiness and cataplexy,” said Elena Koundourakis, head, orexin franchise development & neuroscience programs and portfolio strategy at Takeda. “As leaders in orexin science, we continue to develop one of the most extensive clinical datasets of orexin agonists, with some patients reaching one year of treatment within our clinical studies. The data we are presenting at Sleep Europe add to the body of orexin agonist data we are building to improve our understanding of orexin biology and the potential of our investigative study drug TAK-861 towards establishing a new standard of care for the NT1 community.”

These data presentations add to the scientific community's growing understanding of the potential of OX2R agonists in redefining treatment outcomes for patients with NT1. Takeda is continuing the development of tailored assets to address the needs of people living with sleep-wake disorders including narcolepsy type 2 and idiopathic hypersomnia.

More information on the FirstLight Study, which is currently enrolling, can be found at www.clinicaltrials.gov (identifier: NCT06470828) and www.firstlightstudy.com (for U.S. Audiences only). Takeda does not have any approved therapies for narcolepsy.

About Takeda’s Orexin Agonists for Sleep-Wake Disorders

Takeda is advancing the field of orexin therapeutics with a multi-asset franchise offering tailored treatments to unlock the full potential of orexin science. Orexin is a key regulator of the sleep-wake cycle and is involved in other essential functions, including respiration and metabolism. TAK-861 is the leading program in this franchise and received Breakthrough Therapy designation for the treatment of excessive daytime sleepiness in narcolepsy type 1 from the U.S. Food and Drug Administration (FDA). The company is also progressing orexin agonists in patient populations with normal levels of orexin neuropeptides and other indications where orexin biology is implicated. This includes TAK-360, an oral OX2R agonist being investigated for narcolepsy type 2 and idiopathic hypersomnia, which recently initiated a Phase 1 trial and received Fast Track designation from the FDA.

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at https://www.sec.gov/. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240919392083/en/