Applied Molecular Transport Announces Positive Top-line Phase 2 Results from FILLMORE Trial of Oral AMT-101 in Patients with Chronic Pouchitis

– Met pre-specified efficacy endpoints in chronic pouchitis, a difficult-to-treat inflammatory bowel disease (IBD)
– AMT-101 demonstrated favorable clinical activity and appeared safe and well-tolerated, supporting potentially best-in-class profile
– Achieved clinically meaningful responses in stool frequency and histologic healing in both 3mg and 10mg dosage groups
– Independent Data Monitoring Committee (DMC) recommends advancing to Phase 3 in chronic pouchitis
– Further substantiates potential of AMT-101 and Company’s oral biologics platform
– Investor conference call and webcast today at 8:30 a.m. ET (5:30 a.m. PT)

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif., April 25, 2022 (GLOBE NEWSWIRE) — Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT) today announced positive top-line Phase 2 results from the FILLMORE monotherapy trial for AMT-101 in patients with chronic pouchitis, an orphan indication with significant unmet medical need and no current FDA-approved therapies. AMT-101 is an investigational, once-daily, GI-selective, oral fusion of IL-10 and AMT’s proprietary carrier molecule, which is also in development for the treatment of ulcerative colitis (UC) and rheumatoid arthritis (RA).

FILLMORE Results
The objectives of the FILLMORE trial were to assess the safety and efficacy of AMT-101 in severe chronic pouchitis patients and to select a dose for Phase 3. The trial was designed to measure two key pre-specified efficacy endpoints: 1) symptomatic improvement, as measured by stool frequency response, and 2) histologic healing, as measured by central read.

On the first measure, results from the trial demonstrated that 36.4% (8/22) of patients achieved stool frequency response, defined as a reduction of ≥ 3 stools and ≥ 30% from baseline, OR ≤ post-colectomy normal. Rapid onset of stool frequency response was demonstrated as early as week 2 in both dosage groups and was maintained through the duration of treatment. Top-line interim data demonstrated additional symptomatic improvements in fecal urgency, incontinence and abdominal cramps. The proportion of patients achieving the symptomatic stool frequency response in both dosage groups exceeded the criteria for determining advancement into Phase 3.

On the second measure, 22.7% (5/22) of patients met the pre-specified histologic healing response of Geboes score ≤ 3.1, an objective assessment of disease improvement. FILLMORE patients had a median baseline Geboes score of 5.1, representing severe pouchitis with ulceration and tissue destruction. Both dosage groups demonstrated histologic healing response.

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