Morphic Therapeutic announced the presentation of data from a new MORF-057 phase 1 study at the American College of Gastroenterology (ACG) Annual Meeting 2022 that strongly support the ongoing EMERALD-1 phase 2a study and the upcoming EMERALD-2 phase 2b study of MORF-057. 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 all doses were well tolerated, no safety signals were identified, and a favorable pharmacokinetic profile was observed.

In both single doses of 200 mg MORF-057 and 200 mg BID over the 14 days, MORF-057 demonstrated a4ß7 receptor saturation at Ctrough. Statistically significant changes in lymphocyte subset populations and CCR9 mRNA were observed, consistent with previous studies. About the MORF-057 Phase 1 Study: The study was a two-part phase 1 trial evaluating the safety, pharmacokinetics, and pharmacodynamics of MORF-057 in healthy volunteers.

The first cohort received 25 mg or 100 mg of MORF-057 under fed or fasted conditions. The second cohort received a 200 mg single dose of MORF-057 and, followed by a washout period, 200 mg BID of MORF 057 for 14. About the MORF-057 ACG 2022 Poster Title: Full Target Engagement with Saturation of a4ß7 Integrin Receptor Occupancy Resulting in Changes in Subset of Lymphocytes by MORF-057 Following 200 mg Twice Daily Dosing in Healthy Subjects.

Presenter: Michael Choi, M.D. Contributors: Ajit Chavan, Michael Choi, J. Jones, D. Lee, Maloy Mangada, Ali Hussain, Shilpa Thosar, Dan Cui, Y. Wu, Mimi Chae, Carolyn Soo, Hanh Nguyen, Lellean JeBailey, Adrian Ray, Bruce Rogers, Gerard Bain. About MORF-057: 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.