Guest Column | June 27, 2024

Takeda Chooses Wearable To Improve Patient Experience & Data In Sleep Study

A conversation with Elena Koundourakis, head of the Orexin Franchise Development and Neuroscience Portfolio Strategy, Takeda

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Few people find comfort in sleeping somewhere other than their own bed. Consider then, those who must undergo diagnostics or a therapy that requires an overnight visit to a sleep center. Understandably, the experience is very much unlike sleeping at home and thus opens the opportunity for poorer sleep quality. In addition to that undesirable outcome, traditional sleep studies in a facility can also influence test and/or treatment results.

Takeda, who is leading the development of a multi-asset orexin franchise including TAK-861, an oral orexin receptor 2 agonist designed to potentially address the underlying pathophysiology of narcolepsy type 1, set out to determine the viability of a digital health tool (DHT), or wearable, to collect sleep data from patients. Takeda is collaborating with Beacon Biosignals and its EEG headband that enables at-home sleep monitoring. Previous methods of collecting data involved polysomnography (PSG), also known as a sleep study, or actigraphy.

As Takeda looks to initiate Phase 3 trials for TAK-861 — which in June was announced to have demonstrated statistically significant and clinically meaningful improvements across primary and all secondary endpoints up to eight weeks in Phase 2b trial — and is exploring the use of DHTs to support future clinical development and diagnosis of narcolepsy.

Head of the Orexin Franchise Development and Neuroscience Portfolio Strategy Elena Koundourakis explains why the team decided to pursue the use of DHTs and the benefits of doing so, for both the patients and the data accuracy.

Clinical Leader: As you developed the trial designs for TAK-861 — at what point did you consider a digital health tool (DHT) to take the place of traditional methods of taking your desired measurements and endpoints?

Koundourakis: We have been exploring the use of DHTs across our orexin clinical trials for sleep-wake disorders, including the Phase 3 trials we plan to initiate this year for TAK-861, our most advanced orexin agonist in our orexin franchise. The challenges with currently available assessments of excessive daytime sleepiness (EDS) are that they are subjective and typically require in-clinic testing, which does not reflect a patient’s real-world environment. The ability to objectively measure improvements not just in quality of sleep but also wakefulness and capturing that data over time in the patient’s “natural habitat” is critical to fully understanding the daily burden these patients face and to support the development of tailored treatment approaches for narcolepsy.

How did you research those DHT options and eventually decide upon the Beacon Dreem 3S EEG  headband as a viable tool? What criteria were important to your decision?

A team of biologists, clinicians, statisticians, and engineers from across the company came together to perform a landscape analysis, held discussions with key opinion leaders, and met directly with DHT companies to determine a potential path forward for implementing DHTs in our trials.

For sleep-related disorders, it was critical that we identify a device specifically designed and clinically validated to measure EEG and monitor sleep architecture. Additionally, the ability to rapidly analyze the EEG data and to securely access the data via the cloud offered a huge advantage in using the technology for clinical research and personal use as well. Our key criteria were ensuring accuracy relative to gold standard EEG and PSG and of the accompanying sleep staging software, that it was easy to use, was supported by regulators, and that the technology was mature. The Beacon platform offered the ideal balance across our key criteria.

How might the use of a DHT alleviate the patient and/or caregiver burden? What are the perks for the patient compared to completing a traditional sleep study?

Diagnosing and monitoring sleep-wake disorders requires traveling to a sleep center for a night or more, which is quite burdensome for most people. They may have to request time off from school or work and it may not even be feasible for people who live in remote areas or are primary caregivers. In addition, the limited capacity of sleep centers may cause significant waiting times to get to a sleep study.

Our hope is that with a validated device for use in narcolepsy, we can contribute to limiting the burden of traveling to a sleep center. Beyond the clinical trial setting, a validated DHT could help to improve the diagnostic journey by allowing for a timely differential diagnosis for people living with narcolepsy.

How might the data quality and completeness from the DHT compare to that of standard sleep studies? And what type of physician oversight is needed for each?

Given the already high burden of a traditional sleep study, they are usually limited to a single night. However, sleep is highly variable and a single night study does not fully capture the full extent of sleep pathology. By capturing sleep patterns in a real-world setting, including over longer periods of time and during both the day and night, we aim to better measure and quantify improvements in quality of sleep and wakefulness. Because the Dreem 3S EEG headband collects and analyzes sleep data remotely, it also eliminates the need for specialized technologists.

We are conducting a validation study of the platform to determine that it is fit for purpose for capturing disrupted sleep patterns in people with narcolepsy and to ensure the data quality and completeness can be used to help diagnose patients with a similar performance as the standard of care.

About The Expert:

Elena Koundourakis serves as the Head of Orexin Franchise Development & Neuroscience Programs and Portfolio Strategy at Takeda where she is responsible for leading the development of Takeda’s multi-asset orexin franchise and Takeda’s broader neuroscience therapeutic area unit strategy within Research & Development. She has served as a global program leader across therapeutic areas at Takeda for the past 12 years. Prior to joining Takeda, she worked at Vertex Pharmaceuticals and Boehringer Ingelheim Pharmaceuticals in roles spanning program and portfolio management and regulatory affairs. She received her Ph.D. in biopharmaceutics and clinical pharmacokinetics from the Rheinische Friedrich-Wilhelms-Universität in Bonn, Germany.