Ensho Therapeutics unveils new data on NSHO-101 as once-daily treatment for inflammatory bowel disease

Ensho Therapeutics, Inc., a clinical-stage biopharmaceutical company dedicated to developing oral therapies for inflammatory diseases, has presented promising new data on NSHO-101, a novel once-daily treatment for inflammatory bowel disease (IBD) at the 20th European Crohn’s and Colitis Organisation (ECCO 2025) conference in Berlin, Germany. The latest findings support NSHO-101 as a potential breakthrough in IBD treatment, offering an oral alternative to existing biologic therapies, which are primarily administered via intravenous infusion or subcutaneous injection.

The clinical trial data confirm that NSHO-101 (also known as EA1080) is a selective α4β7 integrin inhibitor, a mechanism validated by the U.S. Food and Drug Administration (FDA) through its approval of injectable biologics such as vedolizumab. By targeting α4β7 integrin, NSHO-101 blocks the binding of mucosal addressin cell adhesion molecule-1 (MAdCAM-1), a process crucial in the inflammatory response associated with inflammatory bowel disease. The latest study findings suggest that NSHO-101 could offer patients a convenient once-daily treatment while maintaining efficacy comparable to established biologics.

How Effective Is NSHO-101 as a Once-Daily Treatment?

Newly presented clinical trial data indicate that NSHO-101, when taken as a once-daily treatment, achieves ≥95% α4β7 integrin receptor occupancy over a 24-hour dosing period. This demonstrates sustained engagement of its target, reinforcing its potential to control inflammatory bowel disease symptoms effectively. Plasma concentrations of NSHO-101’s active metabolite, NSHO-101-M, reached steady-state levels within three to four days of administration, aligning with the period required to achieve maximal inhibition of MAdCAM-1 binding.

Additionally, the study found that inhibition of MAdCAM-1 binding remained above 90% for more than 72 hours following the last 800 mg dose. This prolonged activity highlights NSHO-101’s potential as a once-daily treatment capable of maintaining consistent therapeutic effects over extended periods. Importantly, no treatment-emergent adverse events (TEAEs) or serious safety concerns were observed. Unlike some therapies that affect multiple immune pathways, NSHO-101 selectively targets α4β7 integrin while avoiding α4β1 integrin, ensuring minimal off-target effects and maintaining peripheral blood lymphocyte counts within normal ranges.

Why Is an Oral Alternative to Biologics Important for IBD Patients?

The treatment landscape for inflammatory bowel disease has long been dominated by biologic therapies such as vedolizumab, which have proven highly effective. However, these therapies require administration through intravenous infusions or injections, which may not be ideal for all patients. Many individuals with inflammatory bowel disease experience challenges with accessibility, high costs, and the inconvenience of frequent clinical visits for infusion-based treatments.

According to Brian G. Feagan, M.D., a gastroenterology specialist at Western University, Ontario, the lack of oral alternatives has limited the widespread adoption of α4β7 integrin antagonists, despite their efficacy in managing ulcerative colitis and Crohn’s disease. He emphasized that an oral treatment such as NSHO-101 would provide a significant advantage by increasing accessibility and treatment adherence. A once-daily treatment could reduce the need for clinic visits, offering a more patient-friendly solution for those managing this chronic condition.

What Does NSHO-101’s Phase 1 Clinical Data Reveal?

The Phase 1 clinical trial of NSHO-101 was conducted on 184 healthy volunteers and assessed its safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and food effects. The data confirmed that NSHO-101 effectively binds to α4β7 integrin, validating its ability to block the migration of inflammatory cells into the intestinal lining.

NSHO-101 was generally well tolerated, with no serious adverse events reported. The study also demonstrated that NSHO-101 did not impact peripheral blood lymphocyte counts, further confirming its selectivity for α4β7 integrin while avoiding off-target immune effects. The oral formulation was found to produce stable plasma concentration levels, ensuring consistent therapeutic effects with once-daily dosing. These findings provide strong support for advancing the drug into the next phase of clinical development.

What’s Next for Ensho Therapeutics and NSHO-101?

Following the promising clinical trial data, Ensho Therapeutics has announced plans to initiate Phase 2 clinical trials for NSHO-101 in the first half of 2025. This next phase will focus on patients with ulcerative colitis, evaluating the drug’s ability to provide long-term disease control with an oral, once-daily treatment regimen.

According to Neena Bitritto-Garg, Founder and CEO of Ensho Therapeutics, NSHO-101 has the potential to be a transformational treatment for inflammatory bowel disease. She highlighted that while α4β7 integrin inhibitors are already recognized for their efficacy, the lack of an oral option remains a significant unmet need. She emphasized that NSHO-101’s ability to fully saturate its target with a once-daily dosing regimen, combined with its favorable safety profile, makes it a compelling new option for patients.

The company is eager to evaluate the drug’s efficacy and long-term safety in a real-world patient population. If the Phase 2 clinical trials confirm the findings from the earlier study, NSHO-101 could become a leading oral therapy for ulcerative colitis and potentially Crohn’s disease, redefining the standard of care for inflammatory bowel disease.

Could NSHO-101 Redefine the Future of IBD Treatment?

As the industry shifts towards patient-friendly innovations, NSHO-101 stands out as a game-changing therapy in the treatment of inflammatory bowel disease. The potential for an effective, once-daily treatment could significantly impact patient adherence, accessibility, and overall treatment outcomes.

With strong clinical trial data, minimal safety concerns, and a proven mechanism of action, NSHO-101 is emerging as a leading candidate in the next generation of IBD therapies. As Ensho Therapeutics progresses with its clinical development program, both industry experts and patients are closely watching to see if NSHO-101 can deliver on its promise as a transformational oral therapy for inflammatory bowel disease.