Takeda presented fleshed-out Phase 2b data for a narcolepsy drug touted by its CEO and reiterated plans to launch Phase 3 trials by September.
Elena KoundourakisThe drug, called TAK-861, was tested at four dose regimens, and all four improved sleep latency scores after eight weeks. Twice-daily regimens recorded higher numerical improvements, and Elena Koundourakis, head of Takeda’s orexin franchise, said Monday that those doses showed better profiles. Takeda isn’t revealing the pivotal trial design yet for TAK-861, an oral orexin receptor 2 (OX2R) agonist.
“The twice-daily regimen provides the optimal pharmacokinetics to capture, if you like, the exposure that’s needed to keep patients awake during the day and then fall [asleep] overnight,” Koundourakis told Endpoints News. “They basically can go back to sleep. It minimizes adverse events like insomnia.”
The data were presented Monday at SLEEP, the American Academy of Sleep Medicine and the Sleep Research Society’s annual meeting, in Houston.
A twice-daily 0.5 mg regimen induced 12.49 minutes of improvement on the maintenance of wakefulness test, or MWT; a twice-daily 2.0 mg regimen improved MWT scores by 23.50 minutes; a twice-daily regimen of 2.0 mg and 5.0 mg saw scores go up by 25.42 minutes; and a once-daily 7.0 mg dose improved the MWT by 14.96 minutes.
Patients in the placebo group saw their MWT scores worsen by 1.16 minutes. The p-values for all regimens came in at p<0.001, Takeda said.
The Phase 2b study for TAK-861 saw no serious adverse events arise from treatment. No patients dropped out due to side effects.
Takeda had toplined the data in February, saying TAK-861 hit the primary endpoint of improvements in sleep latency measured by the MWT. The data convinced the company to “rapidly” advance the drug into Phase 3 trials for narcolepsy type 1. The drug is not moving forward in narcolepsy type 2.
Leerink analyst Marc Goodman wrote in a note last month that the latency data, released in an abstract in late May, “provides realistic expectation of the efficacy of the class.”
Takeda already has experience with the drug class. It was developing another treatment for narcolepsy type 1 and type 2 called TAK-994 before it halted a Phase 2 study due to safety issues and discontinued the program in 2021.
A handful of other companies are developing oral OX2R agonists including Alkermes and Jazz Pharmaceuticals. Alkermes launched a Phase 2 trial for its program, ALKS 2680, in narcolepsy type 1 in April and is planning to start another Phase 2 trial for narcolepsy type 2 before the end of the year. Meanwhile, Jazz paused a Phase 1 study for JZP441 in November due to “visual disturbances” and some cardiovascular effects, Jazz CMO Kelvin Tan said at an investor conference at the time.