Equillium’s Partner Biocon Initiates Phase 2 Study of Itolizumab in Ulcerative Colitis
Equillium’s Partner Biocon Initiates Phase 2 Study of Itolizumab in Ulcerative Colitis
LA JOLLA, Calif.–(BUSINESS WIRE)–$EQ–Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced that Biocon Limited, in collaboration with Equillium, has initiated a Phase 2 clinical study of itolizumab in patients with ulcerative colitis (UC).
The Phase 2 double-blinded placebo-controlled clinical study is evaluating the safety and efficacy of itolizumab for biologics-naïve patients with moderate to severe active UC, where patients are randomized 1:1:1 to receive a fixed dose of 140 mg of itolizumab, adalimumab, or placebo every two weeks for a 12-week treatment period, with adalimumab non-responders able to cross over to itolizumab. The study is expected to enroll up to 90 patients in multiple clinical trial sites in India. The trial design and initiation have been a collaborative effort, with help from the gastroenterologist community and leading global clinical and scientific experts in the field of inflammatory bowel disease (IBD).
“T cells play a pivotal role in the immune response that leads to IBD and preclinical models show a role for CD6 in disease pathogenesis,” said Dr. Maple Fung, senior vice president of clinical development at Equillium. “As itolizumab has a novel dual mechanism of action that modulates both the activity and trafficking of CD6-expressing T effector cells, it is a promising candidate for treatment of ulcerative colitis, where the severe inflammation can be debilitating. Additional supportive rationale can be found in our ongoing program investigating itolizumab in severe acute graft-versus-host disease, where our Phase 1b EQUATE study demonstrated meaningful complete responses, particularly in those with lower gastroenterological symptoms. We’re excited to see the UC study begin enrollment, as it may provide evidence of an efficacy signal for the use of itolizumab in the treatment of patients with ulcerative colitis.”
“We are encouraged by the progress being made on our high-value, multi-indication molecule, itolizumab, in collaboration with Equillium,” said Siddharth Mittal, managing director and chief executive officer of Biocon Limited. “The commencement of the Phase 2 clinical study, that will provide data related to its efficacy as a treatment of ulcerative colitis, is an important step forward in our efforts to bring the potential benefit of itolizumab to patients in India suffering from this disease. The development also underpins Biocon’s commitment to bring innovative, affordable medicines, that address unmet patient needs, to market expeditiously.”
For more information on UC and Biocon’s clinical study of itolizumab in UC, as well as queries to enroll in the study, please write to firstname.lastname@example.org.
Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited. Equillium has executed an exclusive option and asset purchase agreement for the development and commercialization of itolizumab with Ono Pharmaceutical Co., Ltd.
Equillium is a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical need. The company’s pipeline consists of the following novel immunomodulatory assets targeting immuno-inflammatory pathways. Itolizumab, a first-in-class monoclonal antibody that targets the CD6-ALCAM signaling pathway which plays a central role in the modulation of effector T cells, is currently in a Phase 3 study for patients with acute graft-versus-host disease (aGVHD) and is in a Phase 1b study for patients with lupus/lupus nephritis. EQ101 is a first-in-class tri-specific cytokine inhibitor that selectively targets IL-2, IL-9, and IL-15. Equillium is currently enrolling patients in a Phase 2 proof-of-concept study of EQ101 for patients with alopecia areata. EQ102 is a bi-specific cytokine inhibitor that selectively targets IL-15 and IL-21. Equillium is currently enrolling patients in a Phase 1 study of EQ102, including healthy volunteers and celiac disease patients.
For more information, visit www.equilliumbio.com.
About Biocon Limited
Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led, global biopharmaceutical company committed to enhancing affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune diseases. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets, as well as generic formulations in the US and Europe. It also has a pipeline of promising novel assets in immunotherapy under development. For more information, visit www.biocon.com.
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