MORRIS PLAINS, N.J., Feb. 21, 2025 (GLOBE NEWSWIRE) -- Ensho Therapeutics, Inc., a privately held, clinical-stage biopharmaceutical company focused on developing breakthrough oral therapies for patients with inflammatory diseases, announced today the presentation of additional supportive data for NSHO-101 (also known as EA1080) as a potential once-daily treatment for inflammatory bowel disease (IBD) at the 20th congress of the European Crohn’s and Colitis Organisation (ECCO 2025) meeting being held in Berlin, Germany.
The presentation, entitled “Oral α4β7 integrin antagonist EA1080 (NSHO-101) demonstrates target engagement and α4β7 integrin receptor occupancy following once-daily administration in healthy volunteers (abstract number EC25-1417),” confirmed earlier Phase 1 clinical trial data in healthy subjects indicating that oral administration of NSHO-101 provides near-complete inhibition of mucosal addressin cell adhesion molecule-1 (MAdCAM-1) binding to α4β7 integrin on peripheral blood CD4+ T cells. This mechanism is crucial for the recruitment of immune cells to the site of inflammation and has been further substantiated by the U.S. Food and Drug Administration (FDA) approval of a commercially available injectable antibody, vedolizumab.
Data newly presented today demonstrate that a once-daily formulation of NSHO-101 provided sustained, near-complete inhibition of MAdCAM-1 binding to α4β7 integrin on peripheral blood CD4+ T cells with greater than or equal to 95% α4β7 receptor occupancy across the 24-hour dosing interval. Plasma concentrations of once-daily NSHO-101-M (active metabolite form) reached steady-state levels within 3 to 4 days, and this correlated with maximal inhibition of MAdCAM-1 binding (α4β7 receptor occupancy). NSHO-101-M inhibition of MAdCAM-1 binding was sustained at greater than 90% for over 72 hours after the last once-daily dose of 800 mg NSHO-101. No treatment emergent adverse events (TEAEs) or serious TEAEs were reported with the once-daily formulation of NSHO-101 and no effect on peripheral blood lymphocyte counts was observed across the dosing period, confirming no specific engagement of α4β1.
Brian G. Feagan, M.D., FRCPC, Professor of Medicine, Departments of Medicine, Epidemiology and Biostatistics at Western University, Ontario, and lead author of the presentations, stated, “Biologics have revolutionized the management of IBD, but the absence of oral alternatives that can be used prior to biologics limits patients’ access to safe, effective, and patient-friendly therapies. An oral α4β7 integrin antagonist would be a particularly desirable option for the treatment of IBD based upon its proven mechanism of action in IBD, both in ulcerative colitis and Crohn’s disease. These data for NSHO-101 are encouraging, as the potential once-daily formulation adds convenience and may improve compliance for patients that are typically taking multiple medications. It could serve as a welcome alternative treatment option for this serious and often debilitating disease.”
Neena Bitritto-Garg, Founder and Chief Executive Officer of Ensho Therapeutics, stated, “These data clearly indicate that NSHO-101 is effectively saturating the target with a once-daily dosing regimen and has an encouraging safety profile to date. We believe NSHO-101 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. We are initiating a Phase 2 development program in the coming months for NSHO-101 to evaluate the potential to bring a new, convenient oral treatment option to patients with IBD.”
About NSHO-101 (also known as EA1080)
NSHO-101 is a novel, oral, selective α4β7 integrin inhibitor being developed for the potential treatment of patients with IBD. α4β7 is a cell surface receptor that helps regulate the migration of immune cells to the intestine and plays a key role in controlling inflammatory responses. It binds to MAdCAM-1, which is expressed on high endothelial venules in the intestine and is upregulated in response to inflammation. By blocking this interaction, NSHO-101 offers the potential to prevent the adhesion and migration of inflammatory leukocytes into the intestine, thereby reducing inflammation and improving symptoms in inflammatory bowel disease (IBD).
The Phase 1 clinical program for NSHO-101 assessed the safety, tolerability, food effects, pharmacokinetic (PK) and pharmacodynamic (PD) of single and multiple ascending doses of NSHO-101 in 184 healthy volunteers. NSHO-101 demonstrated target engagement in this Phase 1 program. NSHO-101 was generally safe and well tolerated. Ensho plans to initiate Phase 2 clinical development of NSHO-101 as a potential treatment for ulcerative colitis (UC) in the first half of 2025.
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., that is focused on gastrointestinal disease. Ensho is preparing to initiate a Phase 2 clinical program of NSHO-101, the lead asset in the company’s pipeline, as a potential treatment for ulcerative colitis (UC). For additional information on Ensho Therapeutics, Inc., please visit www.enshorx.com.
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