MAdCAM-1

With the introduction of a subcutaneous formulation, ENTYVIO has expanded patient convenience and global accessibility. Continued growth is supported by rising IBD prevalence and ongoing geographic expansion. LAS VEGAS, April 15, 2025 /PRNewswire/ -- DelveInsight's " ENTYVIO Market Size, Forecast, and Market Insight Report" highlights the details around ENTYVIO, a gut-selective biologic developed by Takeda Pharmaceutical. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of ENTYVIO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Takeda Pharmaceutical's ENTYVIO (vedolizumab) Overview Vedolizumab is a biologic medication approved for both intravenous (IV) and subcutaneous (SC) use, with regulatory approvals varying by region. The SC formulation is authorized for use in the United States, European Union, and over 50 other countries, while the IV formulation has received approval in more than 70 countries, including the US and the EU. Collectively, vedolizumab IV and SC have accumulated over one million patient-years of global exposure. Vedolizumab is a humanized monoclonal antibody that selectively targets the alpha4beta7 integrin, blocking its interaction with mucosal addressin cell adhesion molecule 1 (MAdCAM-1) — a protein primarily found on blood vessels and lymph nodes in the gastrointestinal tract. This integrin is present on certain white blood cells involved in the inflammatory processes of ulcerative colitis and Crohn's disease. By disrupting the binding between alpha4beta7 integrin and MAdCAM-1, vedolizumab may reduce the migration of these immune cells into the gut, thereby decreasing inflammation. ENTYVIO Dosage For adults with ulcerative colitis, the advised dosage of ENTYVIO is 300 mg given through intravenous infusion at weeks 0, 2, and 6, followed by maintenance infusions every 8 weeks. Treatment should be discontinued if no clinical improvement is observed by week 14. Learn more about ENTYVIO projected market size for Crohn's disease and ulcerative colitis @ ENTYVIO Market Potential Crohn's disease is a progressive type of inflammatory bowel disease (IBD) that results in chronic inflammation throughout the gastrointestinal tract, most commonly affecting the terminal ileum and colon. This inflammation can lead to complications such as strictures, fistulas, and ulcers. In 2024, there were 1.1 million diagnosed prevalent cases of Crohn's disease in the United States. Current treatment approaches primarily include biologics such as adalimumab (HUMIRA and its biosimilars), ustekinumab (STELARA), infliximab (REMICADE and biosimilars), along with systemic corticosteroids, immunosuppressants, 5-aminosalicylic acid (5-ASA), and other therapies. Among these, adalimumab held the largest market share in the 7MM in 2024, generating around USD 4 billion in revenue for Crohn's disease treatment. In 2024, the market size of Crohn's disease was highest in the US among the 7MM, accounting for approximately USD 8 billion, which is further expected to increase at a CAGR of 4.5%. The Crohn's disease market is projected to expand due to the introduction of novel therapies with improved efficacy and more convenient routes of administration, broader use of biologics in pediatric populations, growing commercial opportunities in biologic-treated patients, advancements in biomarker development for early diagnosis, and the overall rising prevalence of the disease. Discover more about the Crohn's disease market in detail @ Crohn's Disease Market Report Ulcerative colitis is one of the primary types of chronic inflammatory bowel disease (IBD) affecting the gastrointestinal tract. It is an idiopathic and long-standing inflammation of the colonic mucosa, typically presenting with symptoms like diarrhea, abdominal discomfort, and rectal bleeding. In 2023, there were an estimated 3.1 million diagnosed prevalent cases of ulcerative colitis across the 7MM, with numbers expected to rise over the forecast period. According to current US treatment guidelines, mild-to-moderate cases are initially managed with aminosalicylates or by using corticosteroids for induction followed by maintenance therapy with aminosalicylates. For patients with moderate-to-severe disease, maintenance treatment may involve immunosuppressants like azathioprine or 6-mercaptopurine after corticosteroid induction. Alternatively, biologics—particularly anti-TNF agents such as infliximab or adalimumab—can be used alone or alongside immunosuppressants to achieve and sustain remission and mucosal healing. The treatment landscape across the 7MM is categorized into commonly used drug classes, including conventional therapies, anti-TNF agents, anti-adhesion molecule therapies, JAK inhibitors, and others, reflecting some variations in prescribing practices. Looking ahead, the anticipated introduction of novel therapies, increased focus on early detection, enhanced use in secondary care, improved implementation strategies, and growing disease awareness are likely to contribute to more effective management of ulcerative colitis. As a result, the ulcerative colitis market will grow from USD 8.4 billion in 2023 at a significant CAGR by 2034. However, the high costs of new treatments and the financial burden of disease complications may pose challenges to widespread adoption. For a comprehensive view of the ulcerative colitis market, check out the Ulcerative Colitis Market Assessment Emerging Competitors of ENTYVIO Despite the presence of biosimilars, innovation in Crohn's disease and ulcerative colitis treatment remains strong, with several emerging therapies exploring new inflammatory pathways to improve efficacy and long-term outcomes. RHB-104, a combination macrolide antibiotic, is in Phase III trials targeting potential mycobacterial involvement. VELSIPITY, an S1P receptor modulator, works by limiting lymphocyte migration and reducing inflammation. TREMFYA, which inhibits IL-23, is under evaluation for its immune-modulating effects, while ABBV-154, a TNF inhibitor conjugated with a steroid, aims to enhance TNF suppression. Additional pipeline therapies include Merck's TL1A inhibitor Tulisokibart (PRA023/MK-7240) in Phase III and Pfizer's JAK3 inhibitor LITFULO in Phase II. Teva and Sanofi are also developing Duvakitug, a monoclonal antibody targeting TNFSF15. These investigational drugs represent significant progress for patients unresponsive to current treatments. A range of other promising candidates are in development, each targeting unique pathways. Landos Biopharma's Omilancor (BT-11) is in Phase II and acts via LANCL2, while AVB-114 from Avobis Bio/Alimentiv is also in Phase II. Abivax S.A.'s Obefazimod (ABX464) is being studied for its ability to upregulate miR-124. Roche's RVT-3101 (RG6631), an anti-TL1A antibody, is in Phase II trials, and Mesoblast's RYONCIL (Remestemcel-L), a mesenchymal stem cell therapy, is progressing in Phase III, offering regenerative potential. Other noteworthy agents in Phase II include Zasocitinib (TAK-279) from Takeda, a TYK2 inhibitor; AZD7798 from AstraZeneca, targeting CCR9; Sanofi's Balinatunfib (SAR441566), which blocks TNFR1 signaling; AGMB-129 from Agomab Therapeutics, targeting ALK5/TGFβR1; MBF-118 by Medibiofarma, a PPARγ partial agonist; and MORF-057 by Eli Lilly and Morphic Therapeutic, an α4β7 integrin inhibitor. Together, these developments illustrate a robust and diversified IBD pipeline. To know more about the number of competing drugs in development, visit @ ENTYVIO Market Positioning Compared to Other Drugs Key Milestones of ENTYVIO In April 2024, Takeda announced that the FDA has approved the subcutaneous (SC) formulation of ENTYVIO (vedolizumab) for maintenance treatment in adults with moderately to severely active Crohn's disease who have previously received induction therapy with the intravenous (IV) form of ENTYVIO. In September 2023, Takeda announced that the FDA has approved the SC formulation of ENTYVIO to be used as maintenance therapy in adults with moderately to severely active ulcerative colitis following induction treatment with the IV version of ENTYVIO. In September 2023, Takeda announced that the FDA has accepted for review its Biologics License Application (BLA) for the investigational subcutaneous formulation of ENTYVIO as a maintenance treatment for adults with moderately to severely active Crohn's disease, following induction therapy with the intravenous version of ENTYVIO. In April 2023, Takeda announced that the FDA has accepted for review its resubmitted Biologics License Application (BLA) for the investigational subcutaneous formulation of ENTYVIO as a maintenance treatment for adults with moderately to severely active ulcerative colitis following induction therapy with the intravenous version of ENTYVIO. In March 2023, Takeda announced that Japan's Ministry of Health, Labour, and Welfare has approved ENTYVIO Pens and prefilled syringes (108 mg for subcutaneous injection) for use as maintenance therapy in patients with moderate to severe ulcerative colitis. In May 2020, Takeda announced that the European Commission has approved the subcutaneous formulation of ENTYVIO, a gut-targeted biologic, for maintenance treatment in adults with moderately to severely active ulcerative colitis or Crohn's disease. In May 2019, Takeda announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved for an expanded indication of ENTYVIO, allowing its use in treating adult patients with moderately to severely active Crohn's disease. In May 2019, Takeda announced that the FDA has accepted for review the BLA for a SC formulation of vedolizumab, intended for maintenance treatment in adults with moderately to severely active ulcerative colitis. In November 2018, Takeda announced the launch of ENTYVIO in Japan for the treatment of patients with moderately to severely active ulcerative colitis. In June 2014, Takeda announced that ENTYVIO is now commercially available in the United States for treating adults with moderately to severely active ulcerative colitis or Crohn's disease. In May 2014, Takeda announced that the European Commission (EC) has granted Marketing authorization for ENTYVIO. It is the first and only biologic approved at the same time for treating adults with moderately to severely active ulcerative colitis and Crohn's disease who have not responded adequately to, lost response to, or were intolerant of conventional therapies or TNF-alpha inhibitors. In May 2014, Takeda announced that the FDA had granted simultaneous approval of ENTYVIO for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease. Discover how ENTYVIO is shaping the Crohn's disease and ulcerative colitis treatment landscape @ ENTYVIO Infusion ENTYVIO Market Dynamics ENTYVIO has established itself as a leading biologic therapy in the treatment of moderate to severe ulcerative colitis and Crohn's disease. As a gut-selective integrin antagonist, ENTYVIO offers a differentiated mechanism of action compared to anti-TNF therapies, which contributes to its positioning as a safer long-term option, particularly for patients at risk of systemic immunosuppression. Its favorable safety profile and efficacy in inducing and maintaining remission have led to its widespread adoption, particularly among patients who have failed previous therapies. The biologics market for inflammatory bowel disease is highly competitive, with key players including HUMIRA, REMICADE, STELARA, and newer entrants like SKYRIZI and RINVOQ. ENTYVIO has managed to capture significant market share by appealing to both gastroenterologists and patients seeking gut-targeted treatment. Its intravenous formulation, though initially a barrier, has been partially offset by the 2019 launch of the subcutaneous version in global markets, enhancing patient convenience and adherence. However, uptake in the US for the SC version has been slower due to regulatory timelines and physician inertia. Biosimilar competition is also a factor shaping ENTYVIO's future market dynamics. While biosimilars of anti-TNFs are gaining traction, ENTYVIO currently remains insulated due to patent protections, with biosimilar entry expected post-2026. This provides Takeda a limited window to maximize revenue, expand its patient base, and reinforce brand loyalty. Strategic moves such as expanding indications, enhancing real-world evidence, and increasing global access will be crucial to maintaining its competitive edge. Moreover, the shift in payer dynamics and healthcare cost containment efforts are increasingly influencing biologic prescribing behavior. Takeda must continue to demonstrate value through outcome-based contracts and cost-effectiveness data. As newer agents with novel mechanisms enter the market, maintaining differentiation and proving long-term value will be central to ENTYVIO's sustained success. Dive deeper to get more insight into ENTYVIO's strengths & weaknesses relative to competitors @ ENTYVIO Market Drug Report Table of Contents Related Reports Crohn's Disease Market Crohn's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Crohn's disease companies including Novo Nordisk, Eli Lilly and Company, MedImmune, Boehringer Ingelheim, Raziel Therapeutics, Altimmune, Saniona, YSOPIA Bioscience, Innovent Biologics, Glaceum, Shionogi, Aardvark Therapeutics, NuSirt Biopharma, Novartis, CSPC Baike (Shandong) Biopharmaceutical, Jiangsu HengRui Medicine, Carmot Therapeutics, Pfizer, Sciwind Biosciences, Empros Pharma, among others. Crohn's Disease Pipeline Crohn's Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Crohn's disease companies, including Janssen, RedHill Biopharma, Amgen, Pfizer, Prometheus Biosciences, AgomAb Therapeutics, Hoffmann-La Roche, Gilead Sciences, Eli Lilly and Company, Celgene, AstraZeneca, Mesoblast, Alfasigma, Tiziana Life Sciences, Abivax, Arena Pharmaceuticals, Cytocom, HAV Vaccines Ltd, Enzo Biochem Inc., Stero Biotechs, Reistone Biopharma Company Limited, Qu Biologics, Pfizer, Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceuticals, Soligenix, Immunic, Pfizer, Atlantic Healthcare, 4D Pharma, Landos Biopharma, Janssen, Roche, Eisai, Bristol-Myers Squibb, Iltoo Pharma, Suzhou Connect Biopharmaceuticals, Theravance Biopharma, TaiwanJ Pharmaceuticals, Celularity, Cerecor, GlaxoSmithKline, KangStem Biotech, Immunic, Alpha Cancer Technologies, Koutif Therapeutics, Tract Therapeutics, Trio medicines, ChemoCentryx, Algernon Pharmaceuticals, Neuclone, JHL Biotech, Innovative Pharmacological Research (IPHAR) Co Ltd, Innovation Pharmaceuticals, Exeliom Biosciences SAS, AbbVie, Finch Therapeutics, Akeso Biopharma, Draconis Pharma, MakScientific, Engitix, Origo Biopharma, Navidea Biopharmaceuticals, Orchard Therapeutics, Xbrane, Thetis Pharmaceuticals, Temisis Therapeutics, Synedgen, Synlogic, Morphic Therapeutic, Metacrine, Curacle, Commence Bio Inc, Cloud Pharmaceuticals, Chong Kun Dang Pharmaceutical Corp, Avobis Bio LLC, Avexegen Therapeutics, Assembly Biosciences, Aibios Co Ltd, Aclaris Therapeutics, Athos Therapeutics, Denali Therapeutics, Educell doo, among others. Ulcerative Colitis Market Ulcerative Colitis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key Ulcerative Colitis companies, including Eli Lilly and Company, Lipid Therapeutics, Hoffmann-La Roche, Arena Pharmaceuticals, InDex Pharmaceuticals, EA Pharma, Theravance Biopharma, Boehringer Ingelheim, Janssen Research & Development, Lycera, LG Chem, Iltoo Pharma, Immunic, Hutchison Medipharma, Tianjin Hemay Pharmaceutical, Celgene, among others. Ulcerative Colitis Pipeline Ulcerative Colitis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Ulcerative Colitis companies, including Eli Lilly and Company, Lipid Therapeutics, Hoffmann-La Roche, Arena Pharmaceuticals, InDex Pharmaceuticals, EA Pharma, Theravance Biopharma, Boehringer Ingelheim, Janssen Research & Development, Lycera, LG Chem, Iltoo Pharma, Immunic, Hutchison Medipharma, Tianjin Hemay Pharmaceutical, Celgene, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . 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On September 11, 2024, Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for the treatment of moderate to severe active ulcerative colitis (UC) in adult patients. The company claims that Tremfya is the first and only dual-acting inhibitor targeting interleukin 23 (IL-23) to be approved for this indication, solidifying Johnson & Johnson’s leadership position in the field of inflammatory bowel diseases. About GuselkumabGuselkumab is the first IL-23 inhibitor globally approved, selectively binding to the p19 subunit of IL-23 and blocking its interaction with the IL-23 receptor. This mechanism of action yields significant therapeutic effects across various autoimmune diseases. Guselkumab not only inhibits IL-23 but also interacts with the CD64 receptor on cells that produce IL-23. Tremfya has garnered approvals for treating plaque psoriasis, active psoriatic arthritis, and UC. Additionally, in June 2024, Johnson & Johnson submitted a supplemental Biologics License Application (sBLA) to the FDA for the treatment of moderate to severe active Crohn's disease (CD) in adults. Study Data Supporting ApprovalThe FDA's approval for UC was primarily based on data from the Phase 2b/3 QUASAR study. This study assessed the efficacy and safety of Tremfya in adult patients with moderate to severe active UC who had an inadequate response or intolerance to conventional therapies, other biologics, and/or JAK inhibitors. The results demonstrated that 50% of patients receiving Tremfya 200 mg subcutaneously (SC) every four weeks (q4w), and 45% of patients receiving Tremfya 100 mg SC every eight weeks (q8w), achieved the primary endpoint of clinical remission at Week 44, compared to 19% of those receiving placebo (p<0.001). Additionally, one year after maintenance therapy, 34% (200 mg) and 35% (100 mg) of patients achieved endoscopic remission, as opposed to 15% in the placebo group (p<0.001). During the induction treatment phase, the most common adverse reactions (>2%) for both Tremfya and placebo groups were respiratory infections. In the maintenance phase, the most frequent adverse reactions (>3%) among patients treated with Tremfya or placebo included injection site reactions, joint pain, and upper respiratory infections. About IL-23 p19 DrugsIL-23 p40 serves as a common subunit for both IL-12 and IL-23, with p40 antibodies providing a classical immunotherapy by blocking both IL-12 and IL-23 pathways. However, recent developments in IL-23 p19 antibodies, exemplified by guselkumab, have shown superior efficacy and safety profiles compared to p40 antibodies. The p19 subunit, besides forming the classical inflammatory cytokine IL-23 with p40, can also combine with EBI3 to form IL-39, which activates pathways involving IL-23R and gp130. Both IL-23 and IL-39 can trigger intracellular JAK-STAT signaling pathways, thereby stimulating the secretion of IL-17A/F. This sophisticated approach to targeting IL-23 not only reaffirms Johnson & Johnson’s innovative footprint in treating inflammatory and autoimmune diseases but also signals a promising horizon for patients battling these chronic conditions. In October 2023, Eli Lilly's Omvoh (mirikizumab) received FDA approval for the treatment of adults with moderately to severely active ulcerative colitis (UC). This marks the first IL-23p19 antagonist approved for this patient group. Additionally, AbbVie's risankizumab was the first IL-23 inhibitor to receive FDA approval for inflammatory bowel disease (IBD). It was approved for Crohn’s disease (CD) in June 2022 and for UC in June 2024. About Inflammatory Bowel Disease (IBD)IBD is a nonspecific, chronic, relapsing inflammatory condition of the intestines, commonly presenting with symptoms such as diarrhea, rectal bleeding, abdominal pain, fatigue, and weight loss. The precise cause and mechanism of IBD are not fully understood. However, the prevailing theory suggests that it involves an autoimmune dysfunction triggering an abnormal immune response, leading the immune system to attack normal cells in the digestive tract. IBD includes two main disorders: ulcerative colitis (UC) and Crohn's disease (CD).  UC causes inflammation and ulcers on the surface lining of the colon and rectum, whereas CD can affect any part of the digestive tract, typically involving deeper layers of the gut lining. In rare cases, it can also affect the colon and upper gastrointestinal tract. In 2019, the global prevalence of IBD was approximately 4.9 million, with China accounting for 910,000 patients. From 1990 to 2019, the incidence of IBD in Chinese men increased from 1.72 cases per 100,000 to 3.35 cases per 100,000, while in women, the numbers rose from 1.20 to 2.45 per 100,000. The current global market for IBD therapies has expanded to $18 billion. Research indicates that the migration of white blood cells into intestinal tissue is key to the onset and persistence of IBD. This process depends on the specific binding between adhesion molecules on endothelial cells (such as VCAM-1, MAdCAM-1) and integrins on white blood cells, composed of α and β subunits. Targeting and inhibiting these specific interactions can effectively treat intestinal inflammation in IBD. Elevated levels of cytokines such as tumor necrosis factor-alpha (TNF-α), interleukin-12/23 (IL-12/23), and leukocyte adhesion molecules are commonly seen during active disease phases of IBD. Inhibiting these cytokines can effectively disrupt downstream inflammatory responses and leukocyte chemotaxis, which lead to mucosal damage. Other targets such as the Janus kinase (JAK)/STAT pathway and gut microbiota are increasingly being recognized for their roles in IBD. Since the etiology and pathogenesis of IBD remain unclarified, it cannot be cured. Current drug therapies focus on reducing inflammation, maintaining remission, lowering relapse rates, and reducing the need for surgery. Common treatments include anti-inflammatory drugs, immunosuppressants, antibiotics, small molecule oral drugs, and biologics. Compared to traditional drugs like 5-aminosalicylic acids, steroids, and immunosuppressants, biologics are becoming the mainstream treatment for IBD due to their clearer efficacy and better safety profiles. Johnson & Johnson's Position in IBDIn the IBD sphere, Johnson & Johnson has developed TNF-α inhibitors infliximab and golimumab, each generating over $2 billion in sales in 2023. In addition to guselkumab, the company is developing the first IL-12/23 antibody Stelara (ustekinumab) and the oral IL-23 inhibitor JNJ-2113 for IBD indications. Furthermore, the company is working on a combination therapy for recurrent patients using guselkumab and golimumab (JNJ-8408). According to incomplete statistics, Johnson & Johnson currently has nearly 20 drugs in development for the treatment of inflammatory bowel disease. How to obtain the latest research advancements in the field of biopharmaceuticals? In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!

Ensho Acquired Rights to Develop and Commercialize EA1080 and Portfolio of Other Oral Selective α4β7 Integrin Antagonists in All Territories Excluding Japan, China, Hong Kong, Macau, South Korea, Taiwan and ASEANCHUO-KU, TOKYO and MORRIS PLAINS, N.J., June 27, 2024 (GLOBE NEWSWIRE) -- EA Pharma Co., Ltd. (President, Hidenori Yabune; “EA Pharma”) and Ensho Therapeutics, Inc. (Founder, President and Chief Executive Officer; Neena Bitritto-Garg; “Ensho”) announced today that the two companies have signed a worldwide exclusive license agreement for the rights to develop, manufacture and commercialize novel oral inflammatory bowel disease treatments EA1080 and a portfolio of other oral selective α4β7 integrin antagonists for the global market excluding Japan, China, Hong Kong, Macau, South Korea, Taiwan and ASEAN. Under the terms of the license agreement, in exchange for full commercialization rights in its territory, Ensho will conduct global clinical studies for EA1080, in collaboration with EA Pharma. EA Pharma will receive from Ensho payments on achievement of certain development, regulatory, and commercial milestones, and tiered royalties up to a low double digit percentage of net sales for EA1080. Inflammatory bowel disease (IBD) includes ulcerative colitis (UC) and Crohn’s disease, and is characterized by inflammation in the gut mucosa which results in abdominal pain, diarrhea, and bloody stools. In many cases, patients may experience remission, but ultimately relapse, which results in an overall decline in quality of life. The mechanism of onset of IBD remains unknown. In Japan, IBD is considered a “designated intractable disease” by the Ministry of Health, Labour and Welfare. In 2019, the number of patients registered in Japan with UC and Crohn’s disease were nearly 220,000 and 70,000, respectively, with prevalence increasing in recent years.1 In IBD, lymphocytes and other inflammatory cells excessively surround and invade the gut mucosa, mediated by binding of integrins expressed on the surface of inflammatory cells to adhesion molecules, such as MAdCAM-1, that are excessively expressed on endothelial cells in the gut mucosa. EA1080 is an orally-available small molecule antagonist of α4β7 integrin. EA1080 can selectively inhibit α4β7 integrin cell adhesion mediated by binding to MAdCAM-1, suppressing invasion of lymphocytes into the gut mucosa and quelling inflammation. “EA1080 is a novel orally-available small molecular α4β7 integrin antagonist created based on our original and unique drug discovery platform. We expect that the collaboration with Ensho, which is based in the United States and has strengths in the immunology and inflammatory disease area, will synergize the knowledge of both companies to accelerate the global development of EA1080 to provide a new treatment option for patients with IBD,” said Hidenori Yabune, President of EA Pharma. “Ensho is thrilled to acquire this portfolio of oral, highly selective α4β7 integrin antagonists, led by EA1080, that have been refined through years of impeccable research by the EA Pharma team,” stated Neena Bitritto-Garg, CFA, Founder, President, and Chief Executive Officer of Ensho. “We believe these compounds could be transformational for patients suffering with IBD, as selective α4β7 antagonists have been proven to be safe and effective, but the need for oral agents remains. Our clinical development strategy is already set, and we plan to advance EA1080 into Phase 2 clinical development in the first half of 2025 so that we may deliver new solutions to patients expeditiously.” More Information About EA Pharma EA Pharma Co., Ltd., a subsidiary of Eisai Co., Ltd. for gastrointestinal disease area, was established in April 2016 by integration of the gastrointestinal business unit with more than 60 years' history of the Eisai Group and the gastrointestinal business unit of the Ajinomoto Group having amino acid as its business core. EA Pharma Co., Ltd., is a gastrointestinal specialty pharmaceutical company with a full value chain covering R&D, production & logistics and sales & marketing. For further information on EA Pharma Co., Ltd., please visit https://www.eapharma.co.jp/ About Ensho Therapeutics, IncEnsho Therapeutics, Inc. is a privately held, clinical-stage biopharmaceutical company focused on developing breakthrough oral therapies for patients with inflammatory diseases. The company’s initial focus is on a pipeline of oral, selective small molecule inhibitors of lymphocyte homing integrin α4β7 for inflammatory bowel disease (IBD), a mechanism already validated by a commercially available antibody. Ensho’s assets were acquired from EA Pharma Co., Ltd., a subsidiary of Eisai Co., Ltd. focused on gastrointestinal disease. Ensho is preparing to enter Phase 2 clinical trials in IBD with EA1080, the lead asset in the company’s pipeline. For additional information on Ensho Therapeutics, Inc., please visit www.enshorx.com. Forward-looking statementsThis Website contains forward-looking statements that involve risks, uncertainties, and assumptions. If risks or uncertainties ever materialize or the assumptions prove incorrect, our actual results may differ from those expressed or implied by such forward-looking statements. All statements other than statements of historical facts could be deemed forward-looking, including, but not limited to, any statement of the plans, strategies, and objectives of management for future operations, including but not limited to our clinical development and commercialization plans; any projections of financial information; any statements about historical results that may suggest trends for our business; any statements of expectation or belief regarding future events, potential markets or market size, technology developments, our product pipeline, clinical data, results or practices or the implications thereof, enforceability of our intellectual property rights, competitive strengths or our position within the industry; and any statements of assumptions underlying any of the items mentioned. Media InquiriesEA Pharma Co., Ltd.Corporate Communication Dept.TEL： +81(0)80-4176-5206Ensho Therapeutics, Inc.Investor and Media Relations Email：info@enshorx.com 1 “Basic treatment guidance for patients with ulcerative colitis” (revised March 2020), Research group for intractable inflammatory bowel diseases, Research project on rare and intractable diseases, Health and Labour Sciences Research Grants