Takeda has given up on an AstraZeneca-partnered neurological disorder program after the therapy flunked a phase 2 study.
The Japanese pharma had been evaluating the alpha-synuclein antibody, called TAK-341 or MEDI1341, in a global study of 159 patients with multiple system atrophy (MSA), a rare condition that's caused by a loss of nerve cells in the brain. The midstage trial involved participants receiving intravenous infusions of TAK-341 or placebo every four weeks
The goal of the study was to demonstrate a benefit on the Modified Unified Multiple System Atrophy Rating Scale at Week 52, but Takeda revealed in its third-quarter earnings documents this morning that the study failed to hit its primary or secondary endpoints.
This result “does not support further development in MSA,” Takeda concluded in its earnings document.
The original agreement with AstraZeneca covered TAK-341’s development for both MSA and Parkinson’s disease, but Takeda’s updated pipeline doesn’t list any Parkinson’s programs. However, the alpha synuclein monoclonal antibody is still listed in AstraZeneca’s own phase 2 pipeline.
Takeda also used its latest earnings to disclose that it had dropped a pair of phase 1-stage programs due to “strategic reasons.” They included GDX012, also called TAK-012-1501, an allogeneic gamma delta T-cell therapy the company gained from buying GammaDelta Therapeutics in 2021.
Takeda had been evaluating TAK-012-1501 in a phase 1/2 study in patients with acute myeloid leukemia. But the asset’s future had already appeared hazy after Takeda announced earlier this year that the company was putting cell therapies on the back burner. More recently, Takeda unveiled a broader retreat from the cell therapy field.
The final program being removed from Takeda’s pipeline plan is the development of danavorexton, also known as TAK-925, for narcolepsy. The orexin-2 receptor agonist remains in phase 2 development for respiratory conditions, but Takeda said it has discontinued the phase 1 work on the drug for narcolepsy “due to strategic considerations.”
The decision comes almost exactly a year after the pharma stopped a phase 2 trial of danavorexton in post-anesthesia recovery for patients with obstructive sleep apnea who were at high-risk of developing respiratory complications because of slow enrollment.