Takeda Pharmaceutical has decided to halt the dosing of subjects in the Phase II clinical trials of its oral drug, TAK-994, after a safety signal emerged.
An experimental orexin agonist, TAK-994 can potentially act on orexin 2 receptors.
Takeda decided to halt the Phase II trials immediately as a precautionary measure.
This permits for timely benefit/risk profile analysis of TAK-994 and to decide on the further steps of the programme.
Takeda Pharmaceutical Neuroscience therapeutic area unit head Sarah Sheikh said: “Ensuring the safety of patients participating in clinical studies is of the utmost importance as we strive to develop transformative medicines.
“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 July this year, TAK-994 obtained breakthrough therapy status from the US Food and Drug Administration (FDA).
TAK-994 was being analysed to treat excessive daytime sleepiness (EDS) in people with narcolepsy type 1 (NT1).
A chronic neurological disorder, NT1 modifies the sleep-wake cycle.
The FDA granted breakthrough status to TAK-994 partly based on clinical findings from early phase and initial studies.
These data showed the drug’s potential ability to significantly boost objective, as well as subjective, daytime wakefulness measurements in people with NT1.
Takeda noted that the company is progressing its multi-asset orexin franchise which comprises TAK-861, the oral orexin agonist.
TAK-861 is currently being evaluated in the Phase I trial.
Last month, Takeda reported that its investigational drug, pevonedistat, in combination with azacitidine, failed to meet the primary endpoint of the Phase III PANTHER trial in rare leukaemia patients.