Worldwide License Agreement for EA1080, Oral Selective α4β7 Integrin Antagonist, Signed between EA Pharma and Ensho Therapeutics

CHUO-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, Inc
Ensho 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.

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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