AMT-101 for the Treatment of Inflammatory Disorders
AMT-101 is a novel, gut-selective, investigational oral biologic fusion protein of interleukin 10 (IL-10), an anti-inflammatory cytokine, in development for the treatment of inflammatory disorders, including ulcerative colitis (UC) and other gastrointestinal (GI) disorders.
Derived from AMT’s proprietary platforms, AMT-101 is engineered to harness the power of natural biologic transport mechanisms within the GI tract allowing it to cross the barrier of the intestinal epithelium and enhance localized IL-10 directly within the immune-cell rich environment of GI tissue where up to 75 percent of immune cells reside. This privileged access to the immune system creates the potential for AMT-101 to address, at its point of origin, the immune dysregulation that gives rise to UC, and restore immune homeostasis with minimal systemic exposure and potentially fewer adverse events compared to systemic administration of IL-10. Data from preclinical studies evaluating orally administered AMT-101 demonstrated potent immunomodulation and anti-inflammatory activity.
Phase 1a/b Clinical Trial Underway in Adults with Ulcerative Colitis
In Month 2019, AMT announced that the first patient was dosed in the Phase 1b portion of a first-in-human, multi-center, double-blind, placebo-controlled clinical trial designed to evaluate the safety and tolerability of AMT-101 in adult patients with UC. Secondary objectives include assessment of the pharmacokinetics and pharmacodynamics. The company expects to complete enrollment in the trial in late 2019.
Initial data from the first 20 subjects dosed with active drug in the Phase 1a portion of the trial suggest that AMT-101 is safe and well tolerated, with no serious adverse events reported. Notably, none of the subjects receiving AMT-101 experienced anemia or any relevant reductions in hemoglobin, which have been historically associated with systemically injected IL-10.
The Charité Research Organisation, a leading clinical research institution based in Berlin, Germany, is a key clinical site and partner in both the Phase 1a and Phase 1b trials that are being overseen by Robarts Clinical Trials, a global clinical contract research organization specializing in inflammatory bowel diseases (IBD).
About Ulcerative Colitis
Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) that affects the innermost lining of the colon and causes ulcers to form. The severity of UC varies in individuals and includes symptoms, such as bloody diarrhea, rectal bleeding, tenesmus, urgency, fecal incontinence and, in more severe cases, abdominal pain, anorexia and fever. While not yet fully understood, research suggests UC could be caused by the interplay of a variety of factors, including genetics, environmental factors and inflammation in the gastrointestinal tract. It is estimated that approximately 700,000 individuals in the United States and 2.1 million individuals in Europe are afflicted with UC. While there are currently multiple therapeutic options for the treatment of UC, approximately half of all UC patients relapse in any given year, underscoring the need for new treatment options.