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Biotech Stock News Bites: Evelo Biosciences (NASDAQ: $EVLO) 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


February 14, 2020 ( Newswire) ( Biotechnology Stock News Bites- CAMBRIDGE, Mass.,Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing a new modality of orally delivered, systemically acting biologics, reported on the close yesterday, 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."

Inflammation 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.

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