The stock of biopharmaceutical company Morphic Therapeutic (Nasdaq: MORF) has been trading at an uptick of +104.98% to $74.12 in early trading today (10:55 a.m. EST). The price rise came following an announcement of positive results of an ongoing clinical study for the treatment of inflammatory bowel disease (IBD).
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What has actually happened?
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Morphic Therapeutic focuses on the development of a new generation of orally administered oral integrin therapeutics for the treatment of serious chronic diseases. Among the treatments are those for cardiovascular disease, fibrosis, cancer, and autoimmune diseases. Utilizing its proprietary Morphic Integrin Technology (MInT) Platform, the Company plans to advance its pipeline and discovery activities with AbbVie, Janssen, and Schrödinger.
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Morphic Therapeutic has been developing an oral small molecule inhibitor of the α4β7 integrin dubbed MORF-057 for the treatment of IBD and today the company announced the positive interim results from its Phase 1 clinical trial of that inhibitor. The company shared that:
- α4β7 inhibition has been clinically validated for the treatment of IBD, but no oral treatment options are currently available.
- Efficacy, pharmacokinetics, and pharmacodynamics of MORF-057 were assessed in healthy volunteers in this single ascending dose (SAD) clinical trial.
- MORF-057 was well tolerated in the Phase 1 SAD trial with no serious adverse events (SAEs) and no significant lab abnormalities observed in any of the 5 cohorts receiving MORF-057 in single doses ranging from 25 mg to 400 mg.
- The study demonstrated a generally dose-dependent and predictable pharmacokinetic profile with MORF-057.
- In the trial, receptor occupancy (RO) was the most important pharmacodynamic measurement, which expressed the proportion of α4β7 receptors bound by MORF-057 12 hours after the dose.
- Across the three highest dose cohorts, MORF-057 achieved greater than 95% mean α4β7 RO, including more than 99% RO in subjects above the 25mg dose cohorts.
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- Following oral administration twice daily, these single dose data suggest that MORF-057 may reach saturating levels of receptor occupancy.
- The study did not show quantifiable levels of α4β1 RO.