Morphic Therapeutic (Nasdaq: MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today announced positive interim results from its Phase 1 clinical trial of MORF-057, an oral small molecule inhibitor of the α4β7 integrin in development for the treatment of inflammatory bowel disease (IBD). α4β7 inhibition for the treatment of IBD is a clinically validated biologic mechanism but with no currently available oral treatment options. This single ascending dose (SAD) clinical trial was designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of MORF-057 in healthy volunteers.
“MORF-057 was designed to be a potent and selective oral inhibitor of the integrin α4β7 and these data exceeded our expectations for the Phase 1 SAD trial of MORF-057. Importantly, the robust receptor occupancy data provide early clinical proof-of-concept for MORF-057 as a potential oral treatment option for those suffering from IBD,” commented Peter Linde, M.D., chief medical officer of Morphic Therapeutic. “We’re excited to present the totality of the Phase 1 trial data later this year and to leverage this emerging data set to inform the optimal study design for Phase 2 trials in ulcerative colitis and beyond.”
In the Phase 1 SAD trial, MORF-057 was well tolerated in all 5 cohorts receiving MORF-057 in single doses ranging from 25 mg to 400 mg with no serious adverse events (SAEs) and no significant lab abnormalities in any subject. In the study, MORF-057 exhibited a generally dose proportional and predictable pharmacokinetic profile. The key pharmacodynamic measurement in the trial was receptor occupancy (RO), which indicated the percentage of α4β7 bound by MORF-057 12 hours after the dose. MORF-057 achieved greater than 95% mean α4β7 RO across the three highest dose cohorts, including the observation of >99% RO in subjects in each cohort above 25mg. These single dose data demonstrate the potential that MORF-057 will be able to maintain saturating levels of receptor occupancy following twice daily oral administration. MORF-057 was specifically designed to be highly selective for α4β7 and not α4β1, a related integrin. Notably, we did not observe quantifiable levels of α4β1 RO in the study.
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