预约演示
After slimming down, Applied Molecular Transport no closer to taking UC drug into phase 3
2023-03-10
临床2期孤儿药临床结果临床3期临床1期
Applied Molecular Transport ended last year on a downer, with AMT-101 failing an ulcerative colitis trial.
Applied Molecular Transport has already sacrificed a lot last AMT-101 keep its chulcerative colitiseatment on track—including 40% of its staff and early-stage pipeline activities. But despite shedding the extra weight, the company is still searching for a partner to finally get the candidate into phase 3 trials.
Applied Molecular Transports an oral, gut selective, fusion protein of interleuchronic pouchitis company ended last year on a downer, with AMT-101 producing a lower clinical remission rate in ulcerative colitis patients than the placebo cohort. This followed a fail in July when the therapy was put up against Humira in the same indication.
AMT has had betteAMT-101in the pouchitis indication, where it received interleukin-1 (IL-1)ion from the FDA in November. Pouchitis is an inAMT-101ion that can occur at the site of colon surgerulcerative colitisere are no current FDA-approved products.Humira
To make matters worse, it was preciseAMT-101 aim of getting AMT-101 into late-stage development that the company used as a justification for waving goodbye to 40% of its workforce—including co-founder and Chief Scientific Officer Randall Mrsny, Ph.D.—as well as pausing its early-stage development plans back in May.
AMT-101 is also in a phase 2 trial in combination with anti-AMT-101erapy for rheumatoid arthritis patients who are partial or non-responders to anti-TNFα therapy. A top-line readout is due at some point this year.
AMT-101nly other remaining asset is AMT-126, an oral fusion TNFαL-22 that comrheumatoid arthritisal in healthy volunteers last year. The company is nTNFαevaluating next steps for the program,” it said in this morning’s fourth-quarter earnings release.
AMT were pleased to recently presentAMT-126onal positive AMT-101 translational data at ECCO for our phase 2 FILLMORE monotherapy trial in patients with chronic pouchitis,” CEO Tahir Mahmood, Ph.D., said in the release. “We remain focused on exploring a strategic partnership to advance AMT-101 for this important indication, which has been granted orphan drug designation by the FDA.”
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