AMT-101 is a novel, GI-selective, investigational oral recombinant biologic fusion protein of human interleukin 10 (hIL-10), an anti-inflammatory cytokine, in development for the treatment of inflammatory bowel diseases and systemic inflammatory indications.
Designed using AMT’s proprietary platform, AMT-101 is engineered to harness the power of natural biologic transport mechanisms within the intestinal tract, allowing it to cross the intestinal epithelial barrier and interact directly with cells in the rich immunological milieu in intestinal tissue. It is known that up to seventy percent of the body’s immune cells reside in this environment at any given time, giving AMT-101 the opportunity to directly address the immune dysregulation that gives rise to UC and other inflammatory conditions.
AMT has completed a Phase 1a single-ascending dose study in healthy volunteers and a 1b double-blind, placebo-controlled study in adult patients with UC.
AMT-101 will be evaluated in three Phase 2 clinical trials covering a wide spectrum of UC patients: (1) a monotherapy study in biologic-naïve and biologic-experienced patients (trial initiated), (2) a combination study with anti-TNF therapy in biologic naïve patients, and (3) UC patients who have had an ileal pouch-anal anastomosis (IPAA) post-colectomy and have developed an idiopathic chronic inflammatory condition called pouchitis. AMT-101 will also be evaluated in a Phase 2 study of rheumatoid arthritis to explore AMT-101 as a combination therapy with anti-TNFα agents for patients who are partially responsive to anti-TNFα therapies.