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Equillium, Inc. (NASDAQ: EQ) announced the initiation of a Phase 2 clinical study of itolizumab in collaboration with Biocon Limited for treating ulcerative colitis (UC) in India. This double-blinded, placebo-controlled trial aims to evaluate the safety and efficacy of itolizumab compared to adalimumab in biologics-naïve patients. The study will enroll up to 90 patients and is designed to provide insights into itolizumab's potential benefits. Itolizumab, a first-in-class anti-CD6 monoclonal antibody, has shown promise in earlier studies on severe acute graft-versus-host disease.
Positive
Initiation of Phase 2 clinical study for itolizumab in ulcerative colitis indicates progress in developing new treatments.
The trial is in collaboration with Biocon, leveraging expertise in inflammatory bowel disease.
Itolizumab's dual mechanism may provide significant improvements in patient outcomes.
Negative
The outcome of the trial remains uncertain, and previous studies may not guarantee similar results.
Dependence on external collaboration with Biocon could affect the development timeline.
LA JOLLA, Calif.--(BUSINESS WIRE)--
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 ucp2_itoli_study.team@biocon.com.
About Itolizumab
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.
About Equillium
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.
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.
Additional Information and Where to Find It
This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval with respect to the proposed merger or otherwise. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended. In connection with Metacrine, Inc.’s pending acquisition by Equillium, Inc., Equillium filed a registration statement on Form S-4 (File No. 333-268024) containing a joint proxy statement/prospectus of Equillium and Metacrine and other documents concerning the proposed merger with the Securities and Exchange Commission (the “SEC”). EQUILLIUM URGES INVESTORS TO READ THE JOINT PROXY STATEMENT/PROSPECTUS AND THESE OTHER MATERIALS CAREFULLY BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT EQUILLIUM, METACRINE AND THE PROPOSED MERGER. Investors may obtain free copies of the joint proxy statement/prospectus and other documents filed by Equillium and Metacrine with the SEC at the SEC’s website at www.sec.gov. Free copies of the joint proxy statement/prospectus and Equillium’s other SEC filings are also available on Equillium’s website at www.equilliumbio.com.
Equillium, Metacrine and their respective directors, executive officers, certain members of management and certain employees may be deemed, under SEC rules, to be participants in the solicitation of proxies with respect to the proposed merger. Information regarding Equillium’s officers and directors is included in Equillium’s Definitive Proxy Statement on Schedule 14A filed with the SEC on April 13, 2022, with respect to its 2022 Annual Meeting of Stockholders. This document is available free of charge at the SEC’s website at www.sec.gov or by going to Equillium’s Investors page on its corporate website at www.equilliumbio.com. Information regarding Metacrine’s officers and directors is included in Metacrine’s Definitive Proxy Statement on Schedule 14A filed with the SEC on April 7, 2022, with respect to its 2022 Annual Meeting of Stockholders. This document is available free of charge at the SEC’s website at www.sec.gov or by going to Metacrine’s Investors page on its corporate website at www.metacrine.com. Additional information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of proxies in connection with the proposed Merger, and a description of their direct and indirect interests in the proposed Merger, which may differ from the interests of Equillium’s stockholders or Metacrine’s stockholders generally, will be set forth in the joint proxy statement/prospectus when it is filed with the SEC.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as "anticipate", "believe", “could”, “continue”, "expect", "estimate", “may”, "plan", "outlook", “future” and "project" and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Because such statements are subject to risks and uncertainties, many of which are outside of the Company’s control, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to statements regarding the potential benefits and risks of the transactions contemplated by the option and asset purchase agreement entered into by the Company and Ono, including the possibility that Ono does not exercise the option, the Company receives no further payments under the option and asset purchase agreement other than those payable upon signing, the possibility that, if commercialized, itolizumab proves to be more valuable than contemplated by the option and asset purchase agreement, the fluctuation of the foreign exchange rate, the benefit of treating patients with aGVHD or lupus/lupus nephritis with itolizumab, Equillium’s plans and expected timing for developing itolizumab including the expected timing of initiating, completing and announcing further results from the EQUATOR, EQUATE and EQUALISE studies, Equillium’s plans and expected timing for developing EQ101 and EQ102 including the expected timing of initiating, completing and announcing further results from Phase 2 and Phase 1 studies, respectively, the potential for any of Equillium’s ongoing or planned clinical studies to show safety or efficacy, Equillium’s anticipated timing of regulatory review and feedback, Equillium’s cash runway, and Equillium’s plans and expected timing for developing its product candidates and potential benefits of its product candidates. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties related to the abilities of the leadership team to perform as expected; Equillium’s ability to execute its plans and strategies; risks related to performing clinical studies; the risk that interim results of a clinical study do not necessarily predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; potential delays in the commencement, enrollment and completion of clinical studies and the reporting of data therefrom; the risk that studies will not be completed as planned; Equillium’s plans and product development, including the initiation and completion of clinical studies and the reporting of data therefrom; whether the results from clinical studies will validate and support the safety and efficacy of Equillium’s product candidates; risks related to Ono’s financial condition, willingness to continue to fund the development of itolizumab, and decision to exercise its option to purchase itolizumab or terminate the option and asset purchase agreement; changes in the competitive landscape; uncertainties related to Equillium’s capital requirements; and having to use cash in ways or on timing other than expected and the impact of market volatility on cash reserves. These and other risks and uncertainties are described more fully under the caption "Risk Factors" and elsewhere in Equillium's filings and reports, which may be accessed for free by visiting EDGAR on the SEC web site at http://www.sec.govand on the Company’s website under the heading “Investors.” Investors should take such risks into account and should not rely on forward-looking statements when making investment decisions. All forward-looking statements contained in this press release speak only as of the date on which they were made. Equillium undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor & Media Contact
Equillium, Inc. Michael Moore Vice President, Investor Relations Officer & Head of Corporate Communications
619-302-4431
ir@equilliumbio.com
Source: Equillium, Inc.
FAQ
What is the purpose of the Phase 2 clinical study for itolizumab by Equillium (EQ)?
The study aims to evaluate the safety and efficacy of itolizumab in treating biologics-naïve patients with moderate to severe ulcerative colitis.
How many patients will be enrolled in the itolizumab ulcerative colitis trial?
The study is expected to enroll up to 90 patients across multiple clinical trial sites in India.
What is itolizumab and how does it work?
Itolizumab is a first-in-class anti-CD6 monoclonal antibody that targets the CD6-ALCAM pathway, modulating T cell activity and trafficking.
What are the next steps after the Phase 2 clinical study of itolizumab for ulcerative colitis?
Pending results from the study, Equillium may advance further development or seek regulatory approvals based on the findings.
What are the potential market impacts of itolizumab for ulcerative colitis?
If successful, itolizumab could provide a new treatment option for patients with ulcerative colitis, addressing significant unmet medical needs.
