Ensho Therapeutics Advances Next-Gen Oral α4β7 Integrin Inhibitor for Inflammatory Bowel Disease Following Exclusive License from Eisai’s EA Pharma

Jun 29, 2024 11:17 CST Updated 11:17

Eisai

Pharmaceutical Product R&D and Manufacturer

EA Pharma

A pharmaceutical manufacturer dedicated to providing drugs for unmet medical needs

On June 27, in New Jersey, Ensho Therapeutics, a private clinical-stage biopharmaceutical company focused on developing breakthrough oral therapies for patients with inflammatory diseases, announced the acquisition of a series of oral α4β7 integrin inhibitors through a global exclusive license agreement signed with EA Pharma, a subsidiary of Eisai. According to the terms of the agreement, Ensho has the right to develop, manufacture, and commercialize these assets globally, excluding certain Asian jurisdictions (excluding Japan, mainland China, Hong Kong, and Macao).Taiwan,Korea and ASEAN). Ensho means inflammation, flame, or brilliance in Japanese, expressing a deep desire to provide breakthrough oral therapies for patients with inflammatory diseases.

Based on the results of an extensive Phase 1 clinical program, Ensho selected NSHO-101 (also known as EA1080) as its lead candidate. The Phase 1 process evaluated single and multiple ascending doses of NSHO-101 in more than 180 healthy subjects. The results demonstrated favorable pharmacokinetics (PK) and pharmacodynamics (PD), including target engagement. NSHO-101 was generally safe and well-tolerated in healthy subjects. The Phase 1 results support Ensho’s plan to initiate Phase 2 clinical development in the first half of 2025, starting with ulcerative colitis (UC).

In IBD, lymphocytes and other inflammatory cells excessively surround and invade the intestinal mucosa, a process mediated by the binding of integrins expressed on the surface of inflammatory cells to adhesion molecules (such as MAdCAM-1) that are overexpressed on intestinal mucosal endothelial cells. EA1080 is an orally administered small molecule antagonist of α4β7 integrin. EA1080 can selectively inhibit the process mediated by binding to MAdCAM-1.α4β7Integrins mediate cell adhesion, inhibit lymphocyte infiltration into the intestinal mucosa, and alleviate inflammation.

Neena Bitritto Garg, Founder, President, and Chief Executive Officer of Ensho, said:"We are delighted to acquire the portfolio of AJM300-derived oral selective α4β7 integrin inhibitors, with AJM300 being an oral α4 inhibitor already approved in Japan for the induction treatment of UC. Combined with my history at Eisai and EA Pharma in maintaining impeccable standards for drug development improvement, this has led me to establish Ensho around this portfolio. We believe NSHO-101 could represent a transformative alternative therapy for patients with IBD who continue to suffer despite the availability of multiple treatment options."

Ensho has recruited a world-class executive team with decades of experience in drug development for inflammation and gastrointestinal diseases. This team will work with Ms. Bitritto Garg to develop these important oral formulations and potentially commercialize them for the inflammatory bowel disease (IBD) market.

Ms. Bitritto Garg continued, "I am very pleased to welcome our experienced executive team to Ensho, including Dr. Bittoo Kanwar, former Chief Medical Officer of Telavant, which was acquired by Roche last year. The team's decades of experience in IBD drug development will enable us not only to move quickly but also strategically into Phase 2 clinical development for NSHO-101."

Bittoo Kanwar, M.D. said:"Given the significant unmet medical needs in IBD, the high potential and effective mechanism of α4β7, and the potential of our new oral clinical development candidate to offer differentiated attributes for patients and doctors seeking treatment alternatives, advancing Ensho and its promising IBD asset portfolio with Neena presents an extremely attractive opportunity. Collaborating with the newly established Ensho team, many of whom have a long history of collaboration, we look forward to rapidly advancing our lead asset NSHO-101 into Phase 2 clinical development early next year."

Ensho Therapeutics originates from Bitritto-Garg's business development experience at EA Pharma and Eisai, as well as the company’s management experience in its critical alliance with Biogen on Leqembi (lecanemab), which is currently being launched in multiple countries for the treatment of early Alzheimer’s disease. She brings to Ensho nearly a decade of equity research analyst experience covering the biotechnology sector, including the fields of neuroscience and immunology therapeutics. Prior to founding Ensho, she led biotechnology and biopharmaceutical equity research strategies at several global banks, including Citigroup, where she served as the head of U.S. biotechnology equity research.

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