- Applied Molecular Transport Inc (NASDAQ:AMTI) announced Phase 2 topline results from the FILLMORE monotherapy trial for AMT-101 in chronic pouchitis.
- Pouchitis is inflammation in the lining of a pouch created during surgery to treat ulcerative colitis or certain other diseases.
- The trial demonstrated that 36.4% (8/22) of patients achieved stool frequency response.
- Rapid onset of stool frequency response was demonstrated as early as week 2 in both 3mg and 10mg dosage groups and was maintained throughout the treatment.
- Interim data demonstrated additional symptomatic improvements in fecal urgency, incontinence, and abdominal cramps.
- 22.7% (5/22) of patients met the pre-specified histologic healing response of Geboes score ≤ 3.1, an objective assessment of disease improvement. Both dosage groups demonstrated histologic healing responses.
- AMT-101 appeared safe and well-tolerated.
- Why AMTI stock is falling: Investors are probably reacting to the fact that the independent DMC recommended advancing AMT-101 to Phase 3 with the 3mg dose and not the higher dose.
- AMT anticipates topline results from its additional Phase 2 trials of AMT-101 as follows: MARKET trial in combination with anti-TNFα for UC in Q2 of 2022, LOMBARD trial as a monotherapy for UC in 2H of 2022, and the CASTRO trial in combination with anti-TNFα for RA in 2H of 2022.
- Price Action: AMTI shares are down 14.4% at $4.01 during the market session on the last check Monday.
