Takeda Launches Two Phase 3 Clinical Trials in China for TAK-861, a Breakthrough Therapy Targeting Hypersomnia Disorders

Nov 07, 2024 10:18 CST Updated 10:18

Takeda

Biopharmaceutical Manufacturer

▎WuXi AppTec Content Team Report

The official website of China's Drug Clinical Trial Registration and Information Disclosure Platform recently disclosed,TakedaTwo international multi-center Phase 3 clinical studies of TAK-861 have been initiated in China, including one evaluating TAK-861Treatment of Narcolepsy with CataplexyResearch on efficacy and safety, and a study inPatients with selected central hypersomnia disordersA study evaluating the long-term safety and tolerability of TAK-861 in subjects.

Public information shows that TAK-861 is aOral orexin receptor 2 (OX2R) agonist. The product treatsType 1 Narcolepsy (NT1)Indications have previously been included in the breakthrough therapy category by China's NMPA, and have also been grantedU.S. FDA Grants TreatmentNT1 in ChinaExcessive Daytime SleepinessTheBreakthrough Therapy Designation.

Screenshot source: Official website of the Chinese Drug Clinical Trial Registration and Information Disclosure Platform

NT1 is a chronic, rare central nervous system hypersomnia disorder, patientsDue toOrexinA large loss of neurons leads to low levels of orexin neuropeptides in the brain and cerebrospinal fluid.As a result, there will beExcessive Daytime Sleepiness (EDS), cataplexy, nighttime sleep disruption, and hallucinations upon falling asleep and waking. These debilitating symptoms significantly reduce quality of life and severely impact the patient's work, daily life, and interpersonal relationships.

Orexin is a key regulator of the sleep-wake cycle and is involved in other fundamental functions such as respiration and metabolism.TAK-861 is Takeda's orexin systemMain items of the product line, itAiming to throughSelective Stimulation of Orexin ReceptorsTo address the orexin deficiency in NT1。Agonists that activate OX2R may substitute for endogenous orexins, activating signaling pathways that promote wakefulness.

Takeda has launched two Phase 3 studies in China, one of which is to evaluate TAK-861.Efficacy and Safety of Treatment for Narcolepsy with Cataplexy (Narcolepsy Type 1)A randomized, double-blind, placebo-controlled study that aims to evaluate the effect of TAK-861 on EDS through the Maintenance of Wakefulness Test (MWT). This study plans to enroll 93 subjects globally. Another study aims to evaluate TAK-861 in subjects with selected central hypersomnia disorders.Long-term Extension Study of Safety and Tolerability, the study plans to enroll 500 subjects internationally.

In June this year, Takeda announced positive results from the Phase 2b clinical trial of TAK-861 in treating type 1 narcolepsy.This was a randomized, double-blind, placebo-controlled, multi-dose Phase 2b clinical trial conducted in 112 patients with NT1.The results showed that all primary and secondary endpoints were achieved with statistically significant and clinically meaningful improvements within 8 weeks.

The primary endpoint showed,At all doses, the increase in sleep latency on the Maintenance of Wakefulness Test (MWT) was statistically significant and clinically meaningful compared to placebo.。Secondary endpoints, including the Epworth Sleepiness Scale (ESS) and weekly cataplexy rate (WCR), achieved consistent results with the primary endpoint.Subjective assessments of sleepiness and cataplexy frequency improved compared to placebo.。Due to these ongoing improvements, the majority of the trialsNT1The patient at 8MWT at the End of the Weekly Treatment PeriodAndESSWithin the normal range.During the study period, no serious adverse events occurred, and the safety results showed that TAK-861 was generally safe and well-tolerated.

BesidesTAK-861，Takeda is also developing a variety of orexin products for other indications involving orexin biology. IncludingTAK-360, an oral OX2R agonist, is studying the treatment of type 2 narcolepsy and idiopathic hypersomnia, recently initiated a phase 1 trial, and received FDA Fast Track designation; andDanavorexton (TAK-925), an intravenous OX2R agonist, a Phase 2 trial is being conducted for patients with moderate to severe obstructive sleep apnea who are undergoing general anesthesia.

Globally, orexin receptor agonist products (including OX1R and OX2R) are also expected to be used for treatment.Insomnia, Sleep Disorders, Circadian Rhythm Sleep Disorders, Alzheimer's Disease, DepressionAnd other neurological and psychiatric disordersPublic data shows that dozens of products targeting orexin receptors are also under development worldwide.。

References:

[1] Official Website of China Drug Clinical Trial Registration and Information Disclosure Platform. Retrieved Nov 4, 2024, from https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

[2]Takeda’s TAK-861 Phase 2b Late-Breaking Data Presentations at SLEEP 2024 Demonstrate Clinically Meaningful Impact of Oral Orexin Agonist in Narcolepsy Type 1 Compared to Placebo. Retrieved June 3, 2024, from https://www.takeda.com/newsroom/newsreleases/2024/tak-861-data-at-sleep-2024-on-narcolepsy-type-1/

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