Patient enrollment expected to be complete by the end of 2019
South San Francisco, Calif., September 9, 2019 — Applied Molecular Transport (AMT), a clinical- stage biopharmaceutical company, today announced that the first patient has been dosed in the Phase 1b portion of a first-in-human clinical trial designed to evaluate the safety and tolerability of AMT-101, a novel oral gut-selective biologic fusion protein of interleukin 10 (IL-10) for the treatment of adults with ulcerative colitis (UC). The company expects to complete enrollment by the end of 2019.
The Phase 1b, multi-center, double-blind, placebo-controlled trial of AMT-101, which is being conducted at four centers in Europe, will evaluate five multiple-ascending dose cohorts randomized to receive either placebo or orally administered AMT-101 once daily for 14 days. Each cohort will enroll four subjects, for a total of 20 subjects. The primary objective of the study is to evaluate the safety and tolerability of AMT-101. Secondary objectives include assessment of the pharmacokinetics and pharmacodynamics.
“We are excited to debut Applied Molecular Transport as we deliver on a major company milestone and advance AMT-101, our lead product candidate for adults with ulcerative colitis, into clinical-stage development,” stated Tahir Mahmood Ph.D., chief executive officer and co-founder of AMT. “In addition to AMT-101, AMT has a pipeline of oral immunomodulatory product opportunities derived from our wholly-owned proprietary platform technologies and in-depth expertise in the field of mucosal immunology. Through our unique approach to treat disease at its point of origin, we are focused on our mission to create safer and more effective oral therapeutic treatment options for patients in need.”
Separately, the company announced encouraging data from the ongoing Phase 1a clinical trial of AMT-101 designed to evaluate the safety and tolerability of AMT-101 in healthy adult volunteers. The Phase 1a trial involves six single-ascending dose cohorts comprised of healthy adults (six per cohort) randomized to receive one dose of either placebo or orally administered AMT-101. Initial data from the first 20 subjects dosed with active drug suggests that AMT-101 is safe and well tolerated, with no serious adverse events reported. Notably, none of the subjects receiving oral gastrointestinal (GI)-selective AMT-101 experienced anemia or any relevant reductions in hemoglobin, which have been historically associated with systemically injected IL-10.
The Phase 1a trial is being conducted at The Charité Research Organisation, a leading clinical research institution based in Berlin, Germany. Both the Phase 1a and Phase 1b trials are being overseen by Robarts Clinical Trials, a global clinical contract research organization specializing in GI diseases.
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 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 selective 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 other inflammatory bowel diseases, 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.
About Ulcerative Colitis
Ulcerative colitis (UC) is a chronic inflammatory bowel disease 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 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.
About Applied Molecular Transport
Applied Molecular Transport (AMT) is a privately held, clinical-stage biopharmaceutical company that is applying its proprietary bioengineering technology platforms to create transformative oral biological therapies for patients with severe autoimmune, metabolic and inflammatory diseases. The company’s innovative approaches harness natural biologic transport mechanisms within gastrointestinal tissue to gain privileged access to the points of immune dysregulation and sites of disease. AMT-101, the company’s lead investigational product candidate, is a proprietary, gut-selective, oral biologic fusion protein of IL-10 that is currently in Phase 1b development in adult patients with ulcerative colitis. Additional plans are underway to evaluate the potential application of AMT-101 for the treatment of other inflammatory and autoimmune disorders. AMT, located in South San Francisco, CA, has amassed a broad global intellectual property portfolio surrounding its multiple technology platforms and therapeutic programs. To learn more, please visit www.appliedmt.com.
Principal, Wheelhouse Life Science Advisors
Senior Partner, Wheelhouse Life Science Advisors