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Applied Molecular Transport (NASDAQ:AMTI) reported data from a phase 2 trial of AMT-101 to treat patients with chronic pouchitis.
Pouchitis is an inflammation that occurs in the lining of a pouch which is created during surgery to treat ulcerative colitis (UC). In certain patients with UC, part of the diseased colon is removed and the bowel reconnected in a procedure called Ileal pouch-anal anastomosis. In the surgery, the end of the small intestine is used to create a pouch which is attached internally to the area above the anus to hold waste before elimination. Pouchitis is characterized by symptoms of excessive stool frequency, urgency and fecal incontinence, among others.
The efficacy goals of phase 2 trial, dubbed FILLMORE, were to measure symptomatic improvement, as measured by stool frequency response; and histologic healing. The trial evaluated 3-mg and 10-mg doses of the drug.
The company said data showed that 36.4% (8/22) of patients achieved stool frequency response, defined as a reduction of ≥ 3 stools and ≥ 30% from the time treatment started.
Applied Molecular added that rapid onset of stool frequency response was seen as early as week 2 in both dosage groups and was maintained through the duration of treatment.
The company noted that the proportion of patients achieving the symptomatic stool frequency response in both dosage groups exceeded the criteria for determining advancing in to phase 3.
In addition, the company said that 22.7% (5/22) of patients met the pre-specified histologic healing response of Geboes score ≤ 3.1, an assessment of disease improvement.
AMT-101 appeared safe and well-tolerated.
“Given the severity of the disease and positive top-line results of the trial, we are excited to share these data with FDA and other regulatory agencies to advance AMT-101 development in chronic pouchitis,” said Chief Medical Officer Bittoo Kanwar.
The company added that the independent data monitoring committee recommended advancing AMT-101 with a 3-mg dose in a phase 3 trial to treat chronic pouchitis.
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