Morphic Therapeutic announced the presentation of new phase 1 data from MORF-057 phase 1 studies at the United European Gastroenterology (UEG) Week 2022. These new data describe a 200 mg BID (bis in diem) MORF-057 dose cohort and build upon the previously reported safety and pharmacodynamic data from the MORF-057-101 study. MORF-057 is being developed as an oral a4ß7 inhibitor candidate for the treatment of inflammatory bowel disease (IBD) with an initial focus in ulcerative colitis (UC).

In the phase 1 study, subjects receiving MORF-057 at 200 mg BID twice daily demonstrated a4ß7 receptor saturation and statistically significant increases in circulating central memory, effector memory T lymphocyte and switched memory B lymphocyte populations compared with placebo. At the 25 mg and 50 mg BID exploratory doses, directionally increasing trends were also observed in key pharmacodynamic measures. No safety signals were observed in the study.

The MORF-057 phase 1 study was a randomized phase 1 study evaluating the safety, receptor occupancy and other key biomarker changes in healthy volunteers who received 200 mg BID of MORF 057 or placebo over a 14-day period. MORF-057 is currently being evaluated in the EMERALD Phase 2 studies for patients with mild to moderate ulcerative colitis. Morphic is developing MORF-057 as a selective, oral small molecule inhibitor of the a4ß7 integrin for patients with inflammatory bowel disease (IBD).

a4ß7 has been clinically validated as a target for the treatment of IBD by the success of the approved injectable antibody therapeutic vedolizumab. MORF-057 is designed to block the interactions between a4ß7 on the surface of lymphocytes and the mucosal endothelial cell ligand MAdCAM-1, substantially reducing lymphocyte migration from the bloodstream into intestinal mucosal tissues and causing inflammation that is associated with IBD.