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After slimming down, Applied Molecular Transport no closer to taking UC drug into phase 3

Applied Molecular Transport has already sacrificed a lot last year to keep its chronic pouchitis treatment 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.

The drug, dubbed AMT-101, is an oral, gut selective, fusion protein of interleukin-1 (IL-1). The 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 better luck in the pouchitis indication, where it received orphan drug designation from the FDA in November. Pouchitis is an inflammation that can occur at the site of colon surgery and for which there are no current FDA-approved products.

A phase 2 trial in April showed that AMT-101 helped 36.4% of patients achieve stool frequency response, setting the company up to enter phase 3. But since then, the biotech has struggled to move into the next stage.

To make matters worse, it was precisely this 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-TNFα therapy 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’s only other remaining asset is AMT-126, an oral fusion of IL-22 that completed a phase 1 trial in healthy volunteers last year. The company is now “evaluating next steps for the program,” it said in this morning’s fourth-quarter earnings release.

“We were pleased to recently present additional 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.”