Biocon Limited an innovation-led global biopharmaceutical company announced the initiation of the clinical study of Itolizumab in patients with Ulcerative Colitis (UC) in India, in collaboration with Equillium Inc. This is a phase two randomized, double-blind, parallel-group, placebo and active-controlled (adalimumab), two treatment period study to evaluate the safety and efficacy of Itolizumab for the induction of remission in biologics naïve patients with moderate to severely active UC.
Having obtained approval from the Drugs Controller General of India (DCGI), the study will cover several tertiary hospitals specialized in handling UC cases. The first patient who intended to participate in the study was screened on December 1, 2022.
Siddharth Mittal, Managing Director and CEO, Biocon Limited, said, “We are encouraged by the progress being made on our high-value, multi-indication molecule, Itolizumab, in collaboration with Equillium. The commencement of the Phase two clinical study, that will determine its efficacy for the treatment of Ulcerative Colitis, is an important step forward in our efforts to bring its benefit 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.”
Dr Sandeep Athalye, Chief Medical Officer, Biocon Biologics, added, “Among the developing regions of the world, India has the highest reported incidence of 9.31 cases per 100,000 persons for Inflammatory Bowel Disease and 5.41 cases per 100,000 persons for Ulcerative Colitis. Many of these cases do not respond to standard available therapy, such as corticosteroids, 5 Amino Salicylates (5-ASA) and immunosuppressive drugs, including TNF alfa inhibitors. We believe that Itolizumab can address this need for the treatment of UC, with better remission rates, more durable responses, and a better safety profile.”
Commenting on the development, Dr Maple Fung, Senior Vice President of Clinical Development, Equillium Inc., said: “T cells play a pivotal role in the immune response that leads to Inflammatory Bowel Disease and preclinical models show a role for CD6 in disease pathogenesis. As Itolizumab has a novel dual mechanism of action that modulates both the activity and trafficking of CD6-expressing T effector cells, it is an ideal 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 responses, particularly in those with lower gastroenterological symptoms.”
About Itolizumab
Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM pathway, which can drive several immuno-inflammatory diseases. This unique molecule holds the potential for multiple high-value indications.
Biocon out-licensed Itolizumab to Equillium Inc. in 2017 to develop this molecule for the treatment of severe autoimmune and inflammatory disorders. The company is currently developing Itolizumab for acute graft-versus-host-disease (aGVHD) and Lupus Nephritis. In the studies conducted so far, Itolizumab, in both presentations, i.e., intravenous, and subcutaneous, was found to be safe and well tolerated. Additionally, Itolizumab demonstrated a dose-dependent reduction of cell surface CD6 expression on effector T cells, a leading indicator of drug activity, consistent with its mechanism of action.
ALZUMAb-L is Biocon Biologics’ brand of Itolizumab, developed by Biocon and commercialized in India since 2013 as a novel anti-CD6 antibody for chronic plaque psoriasis. It has also received restricted emergency use authorization from the DCGI for the treatment of moderate to severe acute respiratory distress syndrome (ARDS) in COVID-19 patients, and since then, has saved thousands of lives.
About the Itolizumab clinical study for Ulcerative Colitis
Ulcerative Colitis is a chronic relapsing disorder, characterized by destructive inflammation and epithelial injury in the gastrointestinal tract, with symptoms like diarrhoea and rectal bleeding. Biocon and Equillium’s ongoing clinical study is evaluating the safety and efficacy of Itolizumab for patients with moderate to severely active UC, where patients are administered a fixed dosage of 140 mg every two weeks for six months.
The trial design and initiation has been a collaborative effort, with help from the gastroenterologist community and leading global, clinical and scientific experts in the field of Inflammatory Bowel Disease and UC. The study will also evaluate exploratory biomarkers, including soluble CD6 receptor occupancy, erythrocyte sedimentation rate (ESR) and C-reactive protein, which can help address the heterogeneity of the disease, a key issue for drugs in this field.
