Evelo Biosciences, Inc. Updates Data Following Completion of the Mild and Moderate Atopic Dermatitis Cohort in Its Phase 1B Clinical Trial
January 20, 2021 at 08:33 am
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Evelo Biosciences, Inc. announced updated data following completion of the mild and moderate atopic dermatitis cohort in its Phase 1b clinical trial, which updates the interim data announced on December 9, 2020. The Company previously reported interim data in 23 evaluable patients. These new results now include patient-reported outcomes, as well as all of the physician-reported outcomes for all 24 patients in the cohort. The primary endpoint of the Phase 1b trial was safety and tolerability. EDP1815 was well tolerated in this study with no treatment-related adverse events of moderate or severe intensity, and no serious adverse events. Treatment with EDP1815 resulted in clinically meaningful improvement in the Dermatology Life Quality Index and Patient-Oriented Eczema Measure (POEM). These patient-reported outcomes capture the important impact of the disease on patients, including the domains of itch and sleep, both of which saw improvements in patients receiving EDP1815 in the study. All five measures of itch within the Pruritus-Numerical Rating Scale (Pruritus-NRS), SCORing Atopic Dermatitis (“SCORAD”), POEM, and DLQI showed greater improvements in the treated group at day 56 compared with placebo. The full results also reinforce the positive interim data released on December 9, 2020. Additional physician- reported outcomes of Investigator’s Global Assessment (“IGA”) and SCORAD were consistent with the previously reported Eczema Area and Severity Index (“EASI”) and IGA times Body Surface Area measures. The treatment difference between patients receiving EDP1815 and placebo as measured by percentage change of these well-established efficacy endpoints at day 56. Although this Phase 1b study was not powered to evaluate statistical significance on efficacy measures, the data showed consistent improvements in percentage change from baseline compared to placebo for all three clinical scores: EASI, IGA*BSA, and SCORAD. In addition, 7 out of 16 (44%) patients treated with EDP1815 achieved an outcome of a 50% improvement from baseline in EASI score by day 70, compared with 0% in the placebo group, showing sustained improvement in those patients responding to EDP1815. At the 95% confidence interval, EASI was not statistically significant, whereas IGA*BSA and SCORAD were.
Evelo Biosciences, Inc. is a clinical-stage biotechnology company. The Company is focused on discovering and developing a class of oral medicines that act on immune cells in the small intestine with systemic effects. It has built a platform to discover and develop oral medicines, which target the small intestinal axis (SINTAX). Its product candidates are pharmaceutical preparations of single strains of microbes or their extracellular vesicles (EVs). Its product candidate, EDP1815, is an investigational oral biologic being developed for the treatment of inflammatory diseases. EDP1815 is in clinical development for both psoriasis, driven largely by Th17 inflammation, and atopic dermatitis, driven by TH2 inflammation. EDP2939 is an investigational oral biologic consisting of EVs that it is developing for the potential treatment of inflammatory diseases. EDP1867 is a non-live pharmaceutical preparation of a single strain of Veillonella parvula, isolated from the ileum of a human donor.