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

Rhea-AI Summary

Takeda (TSE:4502/NYSE:TAK) will present additional data from Phase 2b trials and long-term extension study of TAK-861, an investigational oral orexin receptor 2 selective-agonist, for narcolepsy at Sleep Europe 2024. The presentations will highlight TAK-861's impact on daily functioning, cognition, and sleep quality in narcolepsy type 1 (NT1) and type 2 (NT2) patients. Based on positive Phase 2b results, Takeda has initiated the FirstLight Study, a global Phase 3 trial evaluating TAK-861 in adults with NT1. The drug aims to address the underlying pathophysiology of NT1 and could potentially become the first treatment to do so. Takeda is also developing assets for narcolepsy type 2 and idiopathic hypersomnia.

Positive

• Initiation of global Phase 3 trial (FirstLight Study) for TAK-861 in adults with narcolepsy type 1
• Positive Phase 2b trial results for TAK-861 in narcolepsy
• Potential for TAK-861 to be the first treatment addressing the underlying pathophysiology of narcolepsy type 1
• Extensive clinical dataset with some patients reaching one year of treatment

Negative

• None.

Insights

Medical Research Analyst

The presentation of additional data from TAK-861's Phase 2b trials and long-term extension study at Sleep Europe 2024 is a significant development in the field of narcolepsy treatment. The focus on cognitive impairment, quality of nocturnal sleep and sustained attention addresses important aspects of narcolepsy beyond the typical symptoms. This comprehensive approach could potentially revolutionize narcolepsy management.

The initiation of the global Phase 3 FirstLight Study for TAK-861 in adults with narcolepsy type 1 (NT1) is a major milestone. If successful, TAK-861 could become the first treatment targeting the underlying pathophysiology of NT1, offering a paradigm shift from symptom management to addressing the root cause. This could significantly improve patient outcomes and quality of life.

However, it's important to note that while the data is promising, Phase 3 results are still pending. The financial impact on Takeda will depend on the success of these trials and potential market approval.

Neuroscience Expert

The development of TAK-861, an orexin receptor 2 (OX2R) selective-agonist, represents a groundbreaking approach in narcolepsy treatment. By targeting the orexin deficiency in NT1, this drug could potentially restore normal wake-promoting signaling in the brain, addressing the core issue rather than just managing symptoms.

The presentation of data on cognitive impairment is particularly intriguing. Cognitive dysfunction in narcolepsy is often underrecognized but can significantly impact patients' daily functioning. If TAK-861 shows improvement in this area, it could offer a comprehensive treatment option that addresses multiple facets of the disorder.

The ongoing long-term extension study is important for assessing the safety and efficacy of prolonged use. With some patients reaching one year of treatment, this data will be vital in understanding the long-term benefits and potential risks of orexin agonist therapy.

Market Research Analyst

Takeda's progress with TAK-861 positions the company as a potential leader in the narcolepsy treatment market. The global narcolepsy drugs market is projected to grow significantly and a novel treatment addressing the underlying cause of NT1 could capture a substantial market share.

The company's focus on developing a comprehensive dataset for orexin agonists demonstrates a strategic long-term approach. This could not only benefit TAK-861 but also support the development of treatments for other sleep-wake disorders, potentially expanding Takeda's footprint in this therapeutic area.

However, it's important to note that Takeda currently has no approved therapies for narcolepsy. The success of TAK-861 is important for the company to establish itself in this market. While the potential is significant, investors should be aware that drug development carries inherent risks and 100% success is never guaranteed in Phase 3 trials.

− 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

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- 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.

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

Media Contacts:

Japanese Media

Jun Saito

jun.saito@takeda.com

U.S. and International Media

Rachel Wallace

rachel.wallace2@takeda.com

Source: Takeda Pharmaceutical Company Limited

FAQ

What is TAK-861 and how does it work for narcolepsy?

TAK-861 is an investigational oral orexin receptor 2 (OX2R) selective-agonist designed to address orexin deficiency in narcolepsy type 1 by selectively stimulating the orexin receptor 2. It aims to target the underlying pathophysiology of the condition.

What phase of clinical trials is TAK-861 currently in for narcolepsy treatment?

TAK-861 has completed Phase 2b trials and is now entering Phase 3 with the initiation of the FirstLight Study, a global trial evaluating its efficacy and safety in adults with narcolepsy type 1.

When and where will Takeda present the TAK-861 clinical trial data for narcolepsy?

Takeda will present additional data from TAK-861 clinical trials at Sleep Europe 2024, the 27th Congress of the European Sleep Research Society (ESRS), held from September 24-27, 2024 in Seville, Spain.

What aspects of narcolepsy does TAK-861 aim to improve based on the clinical trial data?

According to the clinical trial data, TAK-861 aims to improve daily functioning, cognition, sleep quality, and sustained attention in patients with narcolepsy type 1 and type 2.