NSHO-101 / Eisai, Ensho Therap - LARVOL DELTA

Ensho Therapeutics Announces Presentation of Data Highlighting NSHO-101 as a Once-Daily Oral Agent for the Potential Treatment of Inflammatory Bowel Disease at ECCO 2025 (GlobeNewswire) - P1 | N=184 | NCT04223960 | Sponsor: EA Pharma Co., Ltd. | "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."

P1 data • Inflammatory Bowel Disease

Oral alpha 4 beta 7 (α4β7) integrin antagonist EA1080 (NSHO-101) demonstrates target engagement and α4β7 integrin receptor occupancy following once-daily administration in healthy volunteers (ECCO-IBD 2025) - P1 | "No effect on peripheral blood lymphocyte counts was observed, confirming no specific engagement of α4β1. These results support continued development of a once-daily dosing formulation for future clinical studies."

Clinical • Inflammatory Bowel Disease • CD4

Ensho Therapeutics Announces Upcoming Presentation at ECCO 2025 of Phase 1, Once-Daily Dosing Data for NSHO-101, an Oral α4β7 Inhibitor for Inflammatory Bowel Disease (GlobeNewswire) - "Ensho Therapeutics, Inc...announced today that additional analyses from the Phase 1 development of its lead drug candidate, NSHO-101, will be presented at the 20th congress of the European Crohn’s and Colitis Organisation (ECCO 2025) being held February 19 to 22, 2025, in Berlin, Germany."

P1 data • Inflammatory Bowel Disease

Worldwide License Agreement for EA1080, Oral Selective α4β7 Integrin Antagonist, Signed between EA Pharma and Ensho Therapeutics (GlobeNewswire) - "EA Pharma...and Ensho Therapeutics...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....'We plan to advance EA1080 into Phase 2 clinical development in the first half of 2025"..."

Licensing / partnership • New P2 trial • Crohn's disease • Inflammatory Bowel Disease • Ulcerative Colitis

ORAL ALPHA 4 BETA 7 INTEGRIN ANTAGONIST EA1080 DEMONSTRATES SUSTAINED TARGET ENGAGEMENT IN A FIRST-IN-HUMAN STUDY IN HEALTHY MALE PARTICIPANTS. (DDW 2024) - P1 | "These results demonstrated that EA1080 is clinically safe well tolerated and sufficiently available orally to maintain almost complete and selective inhibition of MAdCAM-1 binding to α4β7 integrin on peripheral blood CD4 + T cells. EA1080 could be a gut-selective and orally available treatment option for IBD. (ClinicalTrials."

Clinical • P1 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • CD4

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Bioavailability, and Food-effects of EA1080 in Healthy Caucasian and Japanese Male Participants (clinicaltrials.gov) - P1 | N=184 | Completed | Sponsor: EA Pharma Co., Ltd. | Recruiting ➔ Completed

Trial completion

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Bioavailability, and Food-effects of EA1080 in Healthy Caucasian and Japanese Male Participants (clinicaltrials.gov) - P1; N=196; Recruiting; Sponsor: EA Pharma Co., Ltd.; N=680 ➔ 196

Clinical • Enrollment change