Of the 105 patients, 17.1% (12/70) of patients treated in the monotherapy arm (AMT-101 3mg) achieved clinical remission versus 20.0% (7/35) in patients receiving placebo at week 12. Clinical remission is defined as Mayo endoscopic subscore of 0 or 1 (blinded central read), rectal bleeding subscore of 0 and stool frequency subscore of 0 or 1.
AMT-101 was well-tolerated. Treatment emergent adverse events (TEAEs) were mostly mild to moderate and were generally balanced between the two arms.
The company plans to present full trial results at an upcoming medical conference.
About LOMBARD
LOMBARD is a Phase 2 double-blinded, placebo-controlled trial that evaluated the safety and efficacy of orally administered AMT-101 monotherapy over 12 weeks in patients with moderate-to-severe UC. The LOMBARD trial randomized 105 patients with 12-week once-daily dosing to either oral AMT-101 3mg or placebo. Safety follow-up is on-going.
About Ulcerative Colitis
UC is a chronic inflammatory bowel disease that causes inflammation in the gastrointestinal (GI) tract. Symptoms may include, but are not limited to, diarrhea, abdominal pain, bloody stools, rectal bleeding, weight loss and fatigue. UC affects millions of people worldwide and may also profoundly impact quality of life. There remains a significant unmet need for safer and more effective oral therapies.
About Pouchitis
Approximately 30% of patients with UC eventually require total colectomy. Ileal pouch-anal anastomosis (IPAA) is the surgical treatment of choice as it avoids permanent ileostomy and is associated with better quality of life outcomes. Up to 60,000 patients in the U.S. alone experience pouchitis, inflammation in the lining of the pouch, after IPAA surgery. Acute pouchitis often responds to antibiotic treatment but up to 50% of pouchitis patients develop chronic pouchitis where patients often relapse on or do not respond to antibiotic therapy. Pouchitis is characterized by clinical symptoms of excessive stool frequency, urgency, fecal incontinence, nocturnal seepage and lower abdominal pain. Pouchitis is an orphan indication with no current FDA-approved therapies.
About AMT-126
AMT-126 is a novel GI-selective, oral fusion of IL-22 and AMT’s proprietary carrier molecule for diseases related to intestinal epithelial (IE) barrier defects. IL-22 is a cytokine that repairs structural and functional defects of the IE barrier and induces microbial defense. AMT-126 is designed to act locally on the epithelial cells of the intestinal tissue, thereby repairing the IE barrier and supporting mucosal healing, potentially translating into clinically meaningful improvements in a broad range of GI-focused, peripheral inflammatory and other diseases.
About AMT-101
AMT-101 is a novel GI-selective, oral fusion of IL-10 and AMT’s proprietary carrier molecule, currently in development in Phase 2 clinical trials for chronic pouchitis, UC and RA. AMT-101 is designed to cross the IE barrier with limited entry into the bloodstream, thereby focusing IL-10 at the primary site of inflammation in IBD, along the intestinal tissue lamina propria, potentially avoiding the side effects observed with systemic administration.
About Applied Molecular Transport Inc.
AMT is a clinical-stage biopharmaceutical company developing novel oral biologic product candidates, by leveraging its technology platform to design biologic product candidates in patient friendly oral dosage forms. AMT’s product candidates are designed to precisely target the relevant pathophysiology of disease. AMT’s proprietary technology platform is incorporated in its product candidates, exploiting existing natural cellular trafficking pathways to drive the active transport of diverse therapeutic modalities across the IE barrier. Active transport is an efficient mechanism that utilizes the cell’s own machinery to transport materials across the IE barrier.
