Lilly Initiates Phase I Clinical Trial in China for LY4268989 (MORF-057), an Oral α4β7 Integrin Inhibitor Acquired for $3.2 Billion

May 12, 2025 11:28 CST Updated 11:28

Eli Lilly

Global Pharmaceutical R&D and Production Company

Local time on May 9,ClinicalTrials.gov official website shows,Eli Lilly and Company registered aIn Chinese and Japanese subjectsEvaluation LY4268989 （MORF-057)Phase I Clinical Study of Pharmacokinetics, Safety, Tolerability, Food Effect, and Drug Interactions.

Source:ClinicalTrials.gov Official Website

This is a randomized, parallel-assigned Phase I clinical study, planning to enroll 66 participants.Tester. The study start date is May 2025, and the completion date is July 2025.

The study has 5 cohorts, where cohorts 1, 4, and 5 are double-blind, and cohorts 2 and 3 are open-label. The specific dosing regimen is as follows.

Source:ClinicalTrials.gov Official Website

The primary endpoint of the study was the maximum concentration from Day 1 to Day 17 in Cohort 1 and Cohort 5.（Cmax）, Area Under the Curve of Blood Drug Concentration-Time（AUC）, Cohorts 1, 3, and 5 experienced adverse events and serious adverse events during the treatment period; from Day 1 to Day 13, Cohort 2'sCmax, AUC, etc.

LY4268989 isDeveloped by Morphic TherapeuticA selective oral α4β7 integrin small molecule inhibitor for the treatment of ulcerative colitis, Crohn's disease, inflammatory bowel disease, etc. In August 2024, Eli Lilly and Company acquired it for 3.2 billion US dollars.Morphic has acquired the product. Currently, the product is under development.Phase II Clinical Trials for Ulcerative Colitis and Crohn's Disease.

Insight database shows that currently, there is only one monoclonal antibody drug targeting the same point globally, which is Takeda Pharmaceutical's Vedolizumab. This drug was first approved for marketing in the United States in 2014 and made its debut in China in 2020. In terms of sales, it has consistently ranked among the top 100 global drug sales lists since 2017. In 2024, the global sales reached 6.287 billion US dollars, making it a real blockbuster drug.

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