Evelo Biosciences, Inc. provided an update on recent positive regulatory interactions on the EDP1815 Phase 2 trial design, resulting in a reduction in the overall development plan timeline to registration. EDP1815 – Phase 2 study in mild to moderate psoriasis:In the second and third quarter of 2019, Evelo reported positive Phase 1b interim clinical data in two cohorts of individuals with mild to moderate psoriasis. EDP1815 was well tolerated at both doses, with no overall difference reported from placebo. There was a reduction in mean Lesion Severity Score and PASI score after 28 days of dosing in both cohorts who received EDP1815. In the high dose cohort alone, there was a continued reduction in bothmean Lesion Severity Score (of 24% vs. placebo of 7%) and PASI score (of 21% vs. placebo of 3%) at 42 days – 14 days following the last dose of the drug1. This may indicate a sustained clinical effect and dose response. Evelo has agreed upon the design of the EDP1815 Phase 2 clinical trial with global regulatory agencies. The dose ranging study will evaluate three doses of a new, improved formulation of EDP1815 versus placebo in approximately180 individuals. The primary endpoint will be the mean reduction in PASI score at 16 weeks. Evelo expects to initiate the trial in the second quarter of 2020 and to announce interim data by the end of 2020. Subject to the Phase 2 clinical data, this study design may enable Evelo to advance directly into Phase 3 registrational studies in 2021. Furthermore, the recent regulatory interactions indicate that Evelo may be able to conduct a smaller overall Phase 3 program than expected, thereby reducing the development timeline to registration. Additional Anticipated 2020 Milestones: EDP1815 – Phase 1b new formulation in mild to moderate psoriasis: Initial data from an additional cohort in the EDP1815 Phase 1b trial to evaluate a new formulation in up to 24 individuals with mild to moderate psoriasis in the second quarter of 2020. EDP1815 – Phase 1b new formulation in mild to moderate atopic dermatitis: Initial data from the Phase 1b clinical trial evaluating a new formulation of EDP1815 in a cohort of 24 individuals with mild to moderate atopic dermatitis in the second quarter of 2020. EDP1066 – Phase 1b new formulation in mild to moderate atopic dermatitis: Initial data from the Phase 1b clinical trial evaluating a new formulation of EDP1066 in a cohort of individuals with mild to moderate atopic dermatitis in the first quarter of 2020. EDP1867 – Phase 1b clinical trial in asthma: Initiation of a Phase 1b clinical trial in individuals with asthma evaluating EDP1867, a new clinical candidate for inflammatory diseases, in the second half of 2020. EDP1503 – Phase 1/2 in oncology: Further data from the ongoing Phase 1/2 clinical trial evaluating EDP1503 in combination with Merck’s anti-PD-1, KEYTRUDA® (pembrolizumab), in individuals with microsatellite colorectal cancer, triple-negative breast cancer or other tumor types who have relapsed on prior PD-1/L1 inhibitor treatment, in the first half of 2020.