EDP1867 / Evelo Biosci - LARVOL DELTA

EDP1867-101: Study in Healthy Participants and Participants With Moderate Atopic Dermatitis & Optionally, Moderate Psoriasis, and/or Mild Asthma (clinicaltrials.gov) - P1 | N=52 | Completed | Sponsor: Evelo Biosciences, Inc. | Active, not recruiting ➔ Completed | N=96 ➔ 52 | Trial completion date: May 2022 ➔ Feb 2022

Enrollment change • Trial completion • Trial completion date • Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Psoriasis • Pulmonary Disease • Respiratory Diseases

Treatment with an orally delivered non-replicating, non-colonizing strain of Veillonella parvula resolves systemic inflammation in murine models of disease (IMMUNOLOGY 2022) - "In an imiquimod-induced psoriasis model, EDP1867 reduced skin inflammation and psoriasis score and Th17 cytokines in the skin.  EDP1867 drives broad based resolution of inflammation and can reestablish normal homeostasis. These data demonstrate that EDP1867 can act as a new oral anti-inflammatory drug that is gut restricted and dependent on local immune recognition within the small intestine, to induce systemic anti-inflammatory effects. EDP1867 is currently in clinical development for treatment of inflammatory diseases."

Preclinical • Dermatitis • Dermatology • Immunology • Inflammation • Psoriasis • IL10

EDP1867-101: Study in Healthy Participants and Participants With Moderate Atopic Dermatitis & Optionally, Moderate Psoriasis, and/or Mild Asthma (clinicaltrials.gov) - P1 | N=96 | Active, not recruiting | Sponsor: Evelo Biosciences, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Psoriasis • Pulmonary Disease • Respiratory Diseases

Regulation of Peripheral Inflammation by a Non-Viable, Non-Colonizing Strain of Commensal Bacteria. (PubMed, Front Immunol) - "Finally, we show that adoptively transferred T cells from EDP1867-treated mice inhibit inflammation induced in recipient mice. These results demonstrate that an orally-delivered, non-viable strain of commensal bacteria can mediate potent anti-inflammatory effects in peripheral tissues through transient occupancy of the gastrointestinal tract, and support the development of non-living bacterial strains for therapeutic applications."

Journal • Atopic Dermatitis • CNS Disorders • Dermatitis • Dermatology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Multiple Sclerosis • Psoriasis

Evelo Biosciences Announces Key 2022 Strategic Priorities and Upcoming Catalysts (GlobeNewswire) - "Evelo Biosciences, Inc...today announced its strategic priorities and upcoming catalysts for 2022. In 2022 the Company will focus on...Progressing EDP1815 in a global Phase 2 clinical trial in atopic dermatitis....Advancing the next wave clinical candidates EDP1867 and EDP2939, the Company’s first microbial extracellular vesicle (EV)....1Q 2022...Initiation of dosing of patients in the EDP1815 Phase 2 trial in mild, moderate, and severe atopic dermatitis; 1H 2022...Data from EDP1867 Phase 1b trial in patients with atopic dermatitis....1H 2023; Topline data from EDP1815 Phase 2 trial in mild, moderate, and severe atopic dermatitis"

P1 data • P2 data • Trial status • Atopic Dermatitis • Dermatology • Immunology

EDP1867-101: Study in Healthy Participants and Participants With Moderate Atopic Dermatitis & Optionally, Moderate Psoriasis, and/or Mild Asthma (clinicaltrials.gov) - P1; N=96; Recruiting; Sponsor: Evelo Biosciences, Inc.; Phase classification: P1a/1b ➔ P1; Trial completion date: Nov 2021 ➔ May 2022; Trial primary completion date: Sep 2021 ➔ Apr 2022

Clinical • Phase classification • Trial completion date • Trial primary completion date • Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Psoriasis • Pulmonary Disease • Respiratory Diseases

Evelo Biosciences, Inc. (EVLO) Q3 2021 Earnings Call Transcript (The Motley Fool) - "....Our phase 1b trial of EDP1867 in a cohort of patients with moderate atopic dermatitis is ongoing. Trial participants are being dosed or stay with a 14-day follow-up period..."

Trial status • Atopic Dermatitis • Dermatology • Immunology

[VIRTUAL] Oral delivery of non-live preparation of Veillonella parvula modulates CNS inflammation via the small intestinal axis: a novel approach to treating neuroinflammatory diseases (ECTRIMS 2021) - "EDP1867 is a pharmaceutical preparation of a single strain of Veillonella parvula isolated from the ileum of a human donor... Our results indicate that SINTAX is a portal to the CNS by immune signaling from the gut. This is a striking finding that suggests a new pathway of biological control of neuroinflammation and type of medicine for its treatment. The efficacy of this non-live bacterial product is evidence that this is a result of a direct pharmacological interaction with host cells in the gut and is not the result of modification of the gut microbiota."

CNS Disorders • Immunology • Inflammation • Multiple Sclerosis

[VIRTUAL] Oral delivery of non-live preparation of Veillonella parvula modulates CNS inflammation via the small intestinal axis: a novel approach to treating neuroinflammatory diseases (ECTRIMS 2021) - "EDP1867 is a pharmaceutical preparation of a single strain of Veillonella parvula isolated from the ileum of a human donor... Our results indicate that SINTAX is a portal to the CNS by immune signaling from the gut. This is a striking finding that suggests a new pathway of biological control of neuroinflammation and type of medicine for its treatment. The efficacy of this non-live bacterial product is evidence that this is a result of a direct pharmacological interaction with host cells in the gut and is not the result of modification of the gut microbiota."

CNS Disorders • Immunology • Inflammation • Multiple Sclerosis

Evelo Biosciences Announces Issuance of U.S. Patent for Pharmaceutical Compositions of Single Strains of Naturally Occurring Bacteria as Medicines (GlobeNewswire) - "Patent covers formulations of Veillonella parvula bacteria, including EDP1867, which is in Phase 1b clinical trial with interim data expected in 4Q 2021....Evelo Biosciences, Inc...announced that the U.S. Patent and Trademark Office has issued a new composition of matter patent (No. 11,090,341) for medicines comprising pharmaceutical compositions of Veillonella parvula bacteria."

P1 data • Patent • Atopic Dermatitis • Dermatology

Evelo Biosciences, Inc. (EVLO) Q2 2021 Earnings Call Transcript (The Motley Fool) - "As a reminder, in our phase 1b trial in a cohort of people with mild and moderate atopic dermatitis, trial participants were dosed for 56 days with EDP1815 or placebo....Our phase 1b trial of EDP1867 in a cohort of individuals with moderate atopic dermatitis is ongoing. Trial participants are being dosed for 56 days with a 14-day follow-up."

Trial status • Atopic Dermatitis • Dermatology • Immunology

Evelo Biosciences Reports First Quarter 2021 Financial Results and Business Highlights (GlobeNewswire) - "Upcoming Key Milestones; EDP1815 – Psoriasis; all data anticipated to be reported in 3Q 2021....including our Phase 2b data from EDP1815 in psoriasis in the third quarter...EDP1867 - Atopic Dermatitis: Interim data from Phase 1b trial expected in 4Q 2021..."

P1 data • P2b data • Atopic Dermatitis • Dermatology • Immunology • Psoriasis

EDP1867 Phase 1a/1b Study in Healthy Participants and Participants With Moderate Atopic Dermatitis and, Optionally, Moderate Psoriasis, and/or Mild Asthma (clinicaltrials.gov) - P1a/1b; N=96; Recruiting; Sponsor: Evelo Biosciences, Inc.

New P1 trial • Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Psoriasis • Pulmonary Disease • Respiratory Diseases

Evelo Biosciences Announces Fourth Quarter and Full Year 2020 Financial Results and Business Highlights (GlobeNewswire) - "EDP1867 in Atopic Dermatitis: In February, Evelo initiated a Phase 1b trial of EDP1867 in healthy volunteers and patients with moderate atopic dermatitis....Upcoming Key Milestones....EDP1867 – Atopic Dermatitis: Interim data from Phase 1b trial expected in 4Q 2021."

P1 data • Trial status • Atopic Dermatitis • Dermatology

Evelo Biosciences Announces Pricing of Public Offering of Common Stock (GlobeNewswire) - "Evelo Biosciences, Inc....announced the pricing of an underwritten public offering of 4,500,000 shares of its common stock, at a public offering price of $15.00 per share...Evelo intends to use the net proceeds from the offering, in addition to its existing cash resources, for the following purposes: (i) continue the development of EDP1815 in a Phase 2 trial in psoriasis and initiate a Phase 2 trial of EDP1815 in atopic dermatitis; (ii) prepare to advance EDP1815 in multiple Phase 3 trials in psoriasis and atopic dermatitis...(iii) continue the Phase 2 and Phase 2/3 clinical trials of EDP1815 for the treatment of hyperinflammation caused by SARs-CoV-2; (iv) advance EDP1867 in a Phase 1b trial in atopic dermatitis; (v) progress its first bacterial extracellular vesicle product candidates into the clinic, including EDP2939 for inflammation and EDP1908 for oncology."

Financing • Atopic Dermatitis • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Oncology • Psoriasis

Evelo Biosciences Expands Clinical Programs and Provides 2021 Guidance on Key Milestones (GlobeNewswire) - "Expected 2021 Milestones: EDP1815 – Atopic Dermatitis: Subject to regulatory approval, initiation of Phase 2 trial in 3Q 2021; Interim data from Phase 2 trial in 1Q 2022; Initiation of Phase 3 trial in 2022, depending on positive Phase 2 data....EDP1867 – Atopic dermatitis: Initiation of Phase 1b trial in 1Q 2021; data expected in 4Q 2021"

New P1 trial • New P2 trial • New P3 trial • P1 data • P2 data • Atopic Dermatitis • Dermatology • Immunology

Evelo Biosciences Reports Second Quarter 2020 Financial Results and Business Highlights (BioSpace) - "EDP1815...Data from Phase 1b trial in atopic dermatitis in 1Q 2021...EDP1867: Data from Phase 1b trial in atopic dermatitis in mid-2021"

P1 data • Atopic Dermatitis • Dermatology • Immunology • Inflammation

Newly added product (GlobeNewswire) - Preclinical, Inflammation

Pipeline update