Takeda Hits Accelerator On TAK-861 After Phase II Narcolepsy Win

The drug maker plans to move the drug into Phase III development for NT1, though it appears to have missed on NT2. But a lack of key toxicities may bode well for the orexin agonist class too.

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Takeda Pharmaceutical Co. Ltd. intends to “rapidly” move its long-acting oral orexin drug for narcolepsy type 1 (NT1), TAK-861, into Phase III development after reporting positive topline results from a Phase IIb study of the drug, marking a change of fortunes from a little more than two years ago when its orexin franchise encountered a significant setback.

The drug maker released topline results 8 February from the randomized, double-blind, placebo-controlled and multiple-dose TAK-861-2001 study of the orexin receptor 2 (OX2R) agonist in 112 patients, saying it met primary and key secondary endpoints and showed the drug was generally safe and well-tolerated

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