Evelo Biosciences Reports Fourth Quarter and Full Year 2019 Financial Results and Business Highlights
—Strong 2019 marked by clinical data that validates platform—
—Lead inflammation candidate EDP1815 showed positive clinical data across two separate cohorts—
—EDP1815 Phase 2 study initiation expected in Q2 2020—
—Multiple clinical readouts across inflammation and oncology portfolio expected throughout 2020—
—Management to host conference call at 8:30 a.m. EST—
CAMBRIDGE, Mass., February 13, 2020 – Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing a new modality of orally delivered, systemically acting biologics, today reported financial results and business highlights for the fourth quarter and full year 2019.
“2019 was a pivotal year for Evelo. We reported positive clinical data supporting the validation of our novel platform and demonstrating that we can target SINTAX™, the small intestinal axis, to drive clinical effects in individuals with psoriasis. These data support the role of SINTAX as an important new therapeutic target with broad potential applicability,” said Simba Gill, Ph.D., chief executive officer of Evelo. “We will build on this momentum in 2020, with multiple clinical readouts planned across our inflammation and oncology portfolio. Based on the initial safety and efficacy data reported last year, we are progressing the development of EDP1815, which could benefit millions of people with mild to moderate psoriasis as well as have potential use in other inflammatory diseases. We also look forward to advancing EDP1867 into a Phase 1b trial in asthma. EDP1867 is a non-replicating monoclonal microbial product candidate for inflammatory diseases.”
EDP1815 – Phase 2 study in mild to moderate psoriasis
•Evelo announced that it had agreed on the design of the EDP1815 Phase 2 clinical trial with the U.S. Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). This dose ranging study will evaluate three doses of an improved formulation of EDP1815 versus placebo in approximately 180 individuals with mild to moderate psoriasis. 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.
•Clinical data from this study may enable Evelo to advance directly into Phase 3 registrational studies in 2021, subject to end of Phase 2 discussions with regulatory agencies.
EDP1815 – Phase 1b new formulation in mild to moderate psoriasis
•Initial clinical data from a cohort of up to 24 individuals with mild to moderate psoriasis treated with the new formulation of EDP1815 is expected in the second quarter of 2020.
EDP1815 – Phase 1b new formulation in mild to moderate atopic dermatitis
•Initial clinical data from a cohort of up to 24 individuals with mild to moderate atopic dermatitis treated with the new formulation of EDP1815 is expected in the second quarter of 2020.
•Following completion of the final cohort of the EDP1066 Phase 1b trial, Evelo has decided to discontinue development of EDP1066 and focus its efforts in inflammatory diseases on EDP1815, EDP1867, and its preclinical pipeline.
•In the EDP1066 Phase 1b trial in mild to moderate atopic dermatitis and mild to moderate psoriasis, EDP1066 was well tolerated with no overall difference reported from placebo.
•In a cohort of individuals with mild to moderate atopic dermatitis treated with the high dose of the new formulation of EDP1066, Evelo observed changes in biomarkers of inflammation consistent with a pharmacodynamic effect which were greater than those previously observed with the high dose of the original formulation in a cohort of individuals with mild to moderate psoriasis.
EDP1867 – Phase 1b clinical trial in asthma
•EDP1867 is a non-replicating monoclonal microbial candidate for the treatment of inflammatory diseases.
•In preclinical studies EDP1867 was shown to resolve TH2-dependent inflammation which underlies atopic diseases including atopic asthma.
•Initiation of a Phase 1b clinical trial evaluating EDP1867 in individuals with asthma is expected in the second half of 2020.
The following information was filed by Evelo Biosciences, Inc. (EVLO) on Thursday, February 13, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.