Takeda Pharmaceutical Company Ltd reports that a safety signal has emerged in Phase 2 studies of TAK-994, an investigational oral orexin agonist being studied for the treatment of excessive daytime sleepiness in patients with narcolepsy type 1. As an immediate precautionary measure, the company has suspended dosing of patients and has decided to stop both Phase 2 studies early. This allows for the timely interpretation of the benefit/risk profile of TAK-994 and to determine next steps for the program.
“Ensuring the safety of patients participating in clinical studies is of the utmost importance as we strive to develop transformative medicines. We are grateful to all of the patients, physicians, and site staff who participated in these important clinical trials,” says Sarah Sheikh, head of the neuroscience therapeutic area unit at Takeda, in a release. “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.”
In the release, Takeda states it is committed to advancing its multi-asset orexin franchise including the oral orexin agonist TAK-861, which is currently in Phase 1 development.