Takeda Suspends TAK-994 Clinical Program in Narcolepsy
October 6, 2021
In a terse statement, Takeda Pharmaceutical disclosed that it had suspended dosing of patients due to an undisclosed safety signal that emerged in phase 2 studies of TAK-994, an investigational oral orexin agonist in development as a treatment for narcolepsy type 1, a rare neurologic disorder characterized by excessive daytime sleepiness.
Narcolepsy type 1 (NT1) is a chronic neurological disorder that alters the sleep-wake cycle. Excessive daytime sleepiness is a hallmark symptom of NT1 and is characterized by a person’s inability to stay awake and alert throughout the day and falling asleep unintentionally or at inappropriate times on a daily basis.
Besides suspending the dosing of patients, Takeda has decided to stop both phase 2 studies early to allow for the timely interpretation of the benefit /risk profile of TAK-994 and to determine next steps for the program.
TAK-994 is designed to selectively target orexin 2 receptors. The U.S. Food and Drug Administration granted Takeda Breakthrough Therapy designation for TAK-994 in late July, which was based, in part, on early phase and preliminary clinical data that indicated TAK-994 may demonstrate substantially improved objective and subjective measurements of daytime wakefulness in NT1 patients.
“Takeda is committed to bringing innovative, safe and effective treatments to patients with narcolepsy,” said Sarah Sheikh, head of the Neuroscience Therapeutic Area Unit at Takeda. “Takeda is committed to bringing innovative, safe and effective treatments to patients with narcolepsy. We are working to quickly assess the totality of available data to inform the further development of TAK-994.”
Takeda is committed to advancing its multi-asset orexin franchise including the oral orexin agonist TAK-861, which is currently in phase 1 development.
Author: Rare Daily Staff
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