Morphic Therapeutic Announces First Healthy Volunteers Dosed in Phase 1 Clinical Trial of MORF-057

First orally available integrin inhibitor from MInT Platform to enter the clinic
MORF-057, inhibitor of α₄β₇ integrin, in development to treat inflammatory bowel disease
Phase 1 program to assess safety and pharmacokinetics of MORF-057 as well as α₄β₇ receptor occupancy as a clinically relevant biomarker

WALTHAM, Mass., Sept. 23, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ: MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today announced that the first healthy volunteers have received MORF-057 in a phase 1 clinical trial designed to evaluate MORF-057’s safety and pharmacokinetic profile in addition to predictive pharmacodynamic signals. MORF-057 is in clinical development as an oral small molecule inhibitor of the α₄β₇ integrin for the treatment of inflammatory bowel disease (IBD) with an initial focus on ulcerative colitis (UC).

“Morphic designed MORF-057 with its MInT Platform, a unique platform for the discovery and development of oral integrin drugs, to be a highly selective and potent orally administered inhibitor of the α₄β₇ integrin, a well-validated target in IBD. The initiation of clinical trials for MORF-057 marks a major step forward in this effort,” stated Dr. Peter Linde, MD, chief medical officer of Morphic Therapeutic. “Based on its extensive preclinical data package, we believe that MORF-057 can selectively target the same clinically validated mechanism as the approved injectable antibody, vedolizumab, but utilizing a substantially more convenient oral small molecule. The MORF-057 phase 1 trial is designed to generate safety and pharmacokinetic data, as well as to provide key measures of α₄β₇ receptor occupancy, at multiple doses being evaluated in this program. These results may provide early clinical proof-of-concept for MORF-057 and we expect to present these data at a major medical conference in the first half of next year.”

About the MORF-057 Phase 1 Clinical Trial
The phase 1 clinical trial is designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of MORF-057 dosed twice daily across three parts enrolling at least 76 healthy volunteers. The initial part of the phase 1 trial will evaluate single ascending doses in 40 or more volunteers across five or more dose cohorts of MORF-057. The second part of the trial will evaluate multiple ascending doses in 24 or more volunteers across at least three dose cohorts of MORF-057. A third part will evaluate the effect of food on the pharmacokinetic effects of MORF-057 in two cohorts of six subjects, each receiving MORF-057 in fed and fasting states. The phase 1 program is designed to generate important receptor occupancy data in each dose cohort that could potentially provide early clinical proof-of-concept and dose selection guidance for use in future studies of MORF-057.