EDP1815 / Evelo Biosci, Abdul Latif Jameel Health - LARVOL DELTA

A randomized, double-blinded, phase 2 trial of EDP1815, an oral immunomodulatory preparation of Prevotella histicola, in adults with mild-to-moderate plaque psoriasis. (PubMed, Front Med (Lausanne)) - P2 | "EDP1815 was well-tolerated with a placebo-like safety profile, and had meaningful efficacy outcomes in psoriasis, validating this novel immunomodulatory approach. https://www.clinicaltrials.gov/search?term=NCT04603027, identifier NCT04603027."

Clinical • Immunomodulating • Journal • P2 data • Dermatology • Immunology • Inflammation • Psoriasis

Immunomodulating effects of the single bacterial strain therapy EDP1815 on innate and adaptive immune challenge responses - a randomized, placebo-controlled clinical trial. (PubMed, Immunol Res) - P1 | "There was a lower influx of interleukin [IL]-1β, IL-6, IL-8, IL-10, interferon [IFN]-γ and tumour necrosis factor in blister fluid of EDP1815-treated participants. EDP1815 had immunomodulatory effects on the innate immune response driven by imiquimod, but no effect on the KLH challenge was observed. Trial registration number: NCT05682222; date: 22 July 2022."

Clinical • Immunomodulating • Journal • Dermatology • Immunology • Oncology • CXCL8 • IL10 • IL6

A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous EDP1815 Trials (clinicaltrials.gov) - P2 | N=287 | Terminated | Sponsor: Evelo Biosciences, Inc. | Active, not recruiting ➔ Terminated; Parent Study (NCT05121480) did not meet the primary endpoint.

Trial termination • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

TACTIC-E: mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Experimental Drugs and Mechanisms (clinicaltrials.gov) - P2/3 | N=454 | Completed | Sponsor: Cambridge University Hospitals NHS Foundation Trust | Recruiting ➔ Completed | N=1407 ➔ 454

Enrollment change • Trial completion • Immune Modulation • Infectious Disease • Novel Coronavirus Disease • CRP • IL6

Clinical translation of anti-inflammatory effects of Prevotella histicola in Th1, Th2, and Th17 inflammation. (PubMed, Front Med (Lausanne)) - P1 | "These clinical effects occur without systemic exposure of EDP1815 or modification of the resident gut microbiota, and with placebo-like safety and tolerability. The breadth of these clinical effects of EDP1815, combined with its excellent safety and tolerability profile and oral administration, suggests the potential for a new type of effective, safe, oral, and accessible anti-inflammatory medicine to treat the wide range of diseases driven by inflammation.Clinical Trial Registration: EudraCT # 2018-002807-32; EudraCT # 2018-002807-32; NL8676; https://clinicaltrials.gov/ct2/show/NCT03733353; http://www.trialregister.nl."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Infectious Disease • Inflammation • Psoriasis

Evaluation of the Immunopharmacology of EDP1815 and EDP2939 (clinicaltrials.gov) - P1 | N=38 | Completed | Sponsor: Evelo Biosciences, Inc. | Recruiting ➔ Completed | N=72 ➔ 38 | Trial completion date: Apr 2023 ➔ Oct 2022 | Trial primary completion date: Apr 2023 ➔ Oct 2022

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Dermatitis • Inflammation

A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous EDP1815 Trials (clinicaltrials.gov) - P2 | N=287 | Active, not recruiting | Sponsor: Evelo Biosciences, Inc. | Enrolling by invitation ➔ Active, not recruiting | Trial completion date: Feb 2024 ➔ May 2023 | Trial primary completion date: Dec 2023 ➔ May 2023

Enrollment closed • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Evelo Biosciences’ Atopic Dermatitis Study Cohort Misses Primary Goal Again, Shuts Study, Lays Off More Staff (Yahoo Finance) - P2 | N=421 | NCT05121480 | Sponsor: Evelo Biosciences, Inc. | "Evelo Biosciences Inc...said its fourth cohort of the EDP1815 Phase 2 trial in atopic dermatitis, consistent with the first three cohorts, failed to meet the primary endpoint of the proportion of patients who achieve an EASI-50 response at week 16. EASI-50 responses or greater were achieved at week 16 in 37.9% of patients dosed with EDP1815 versus 44.7% on placebo in the fourth cohort. Following the results, the company decided to cease further development of EDP1815 in atopic dermatitis....Instead, Evelo will focus its resources on the next-generation extracellular vesicle (EV) platform and EDP2939, its first EV candidate, currently in a Phase 1/2 study in psoriasis....The company said enrollment is complete in the Phase 2 portion of the Phase 1/2 study of EDP2939-101, with topline data expected in Q4 2023."

Discontinued • P1/2 data • P2 data • Atopic Dermatitis • Dermatology • Immunology

A Study Investigating the Effect of EDP1815 in the Treatment of Mild, Moderate and Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=421 | Completed | Sponsor: Evelo Biosciences, Inc. | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Scintigraphy Study to Evaluate the Gastrointestinal Behavior of EDP1815 Oral Dosage Forms (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Evelo Biosciences, Inc. | Active, not recruiting ➔ Completed

Trial completion • Gastrointestinal Disorder

Evelo Biosciences Announces Fourth Quarter and Full Year 2022 Financial Results and Business Highlights (GlobeNewswire) - P2 | N=405 | NCT05121480 | P1 | N=72 | NCT05682222 | Sponsor: Evelo Biosciences, Inc. | "EDP1815 – Atopic Dermatitis; Data from a fourth patient cohort of the Phase 2 study in atopic dermatitis evaluating the faster release capsule is anticipated in 2Q 2023. Cohorts one, two and three did not meet the primary endpoint of EASI-50 improvement as compared to placebo, due to an unusually high placebo response. No conclusions regarding the cause of the high placebo response have been identified....EDP2939 – Psoriasis; A safety and tolerability review was conducted in a first cohort of healthy volunteers in the Phase 1 portion of the trial, with no safety or tolerability concerns identified and resulting in approval to start the Phase 2 part of the trial. In February 2023, Evelo began dosing psoriasis patients in the Phase 2 portion of the trial, with data expected 2H 2023."

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

Evelo Biosciences Provides Clinical and Business Updates (GlobeNewswire) - P2 | N=405 | NCT05121480 | Sponsor: Evelo Biosciences, Inc. | “EDP1815 Phase 2 in Atopic Dermatitis – Topline Data from First Three Cohorts; Data from Fourth Cohort Expected 2Q 2023. The first three cohorts of the EDP1815-207 trial failed to meet the primary endpoint which is the proportion of patients who achieve an outcome of at least a 50% improvement from baseline in Eczema Area and Severity Index (EASI) score, an EASI-50 response, compared to placebo at week 16….In all three cohorts, EDP1815 was well-tolerated. EASI-50 responses or greater were achieved in 41%, 38% and 32% of patients with mild to moderate disease at week 16, in cohorts 1, 2 and 3 respectively….The fourth cohort of the Phase 2 trial of EDP1815 in atopic dermatitis is testing a faster release capsule that potentially enables greater clinical activity.”

P2 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Evaluation of the Immunopharmacology of EDP1815 and EDP2939 (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Evelo Biosciences, Inc.

New P1 trial • Dermatitis • Immunology • Inflammation

A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous EDP1815 Trials (clinicaltrials.gov) - P2 | N=405 | Enrolling by invitation | Sponsor: Evelo Biosciences, Inc. | N=300 ➔ 405

Enrollment change • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study Investigating the Effect of EDP1815 in the Treatment of Mild, Moderate and Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=405 | Active, not recruiting | Sponsor: Evelo Biosciences, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Biomarker Evidence of Anti-inflammatory Effects of EDP1815 in a Phase 2 Psoriasis Clinical Trial (EADV 2022) - No abstract available

Biomarker • Clinical • P2 data • Dermatology • Immunology • Psoriasis

Evelo Biosciences Presents Biomarker Data Demonstrating Anti-inflammatory Effects of EDP1815 in Psoriasis at the 2022 European Academy of Dermatology and Venereology (EADV) Congress (GlobeNewswire) - "Evelo Biosciences, Inc...presented biomarker data demonstrating the broad anti-inflammatory effects of EDP1815....The data were presented in a poster at the 2022 EADV Congress in Milan, Italy....In addition to the systemic inflammation resolution, skin biomarker data from the trial presented at the EADV Congress confirmed gene expression reductions in multiple disease relevant cytokine genes, suggesting inflammation resolving activity in disease tissues. Systemic biomarker analyses from samples taken in the Phase 2 trial confirmed generalized reduction of systemic immune reactivity consistent with re-establishing immune homeostasis."

Biomarker • P2 data • Preclinical • Immunology • Psoriasis

Evelo Biosciences Announces Second Quarter 2022 Financial Results and Business Highlights (GlobeNewswire) - "Evelo Biosciences, Inc...today reported financial results and business highlights for the second quarter 2022....The Company is currently engaging with health authorities in the United States and Europe to solicit feedback on its proposed plans for advancing EDP1815 into registrational trials in psoriasis. Evelo anticipates feedback by the end of 2022."

European regulatory • FDA event • Immunology • Psoriasis

Evelo Biosciences Announces First Quarter 2022 Financial Results and Business Highlights (BioSpace) - "Evelo Biosciences, Inc...today reported financial results and business highlights for the first quarter 2022....Recruitment for the Phase 2 trial of EDP1815 in atopic dermatitis is ahead of plan. Evelo intends to add a fourth cohort to the on-going Phase 2 trial. Patients in this cohort, if enrolled, would receive 1 capsule of EDP1815 with a faster release profile once daily....Data from the first 3 cohorts of the Phase 2 atopic dermatitis trial in mild, moderate, and severe atopic dermatitis is anticipated in 1Q 2023; data from a potential additional fourth cohort is anticipated in 2Q 2023."

P2 data • Trial status • Atopic Dermatitis • Immunology

Scintigraphy Study to Evaluate the Gastrointestinal Behavior of EDP1815 Oral Dosage Forms (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: Evelo Biosciences, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastrointestinal Disorder

Scintigraphy Study to Evaluate the Gastrointestinal Behavior of EDP1815 Oral Dosage Forms (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Evelo Biosciences, Inc. | Completed ➔ Recruiting | N=36 ➔ 48 | Trial completion date: May 2022 ➔ Sep 2022 | Initiation date: Aug 2021 ➔ Jul 2022 | Trial primary completion date: May 2022 ➔ Sep 2022

Enrollment change • Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Gastrointestinal Disorder

A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous EDP1815 Trials (clinicaltrials.gov) - P2 | N=300 | Enrolling by invitation | Sponsor: Evelo Biosciences, Inc.

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Scintigraphy Study to Evaluate the Gastrointestinal Behavior of EDP1815 Oral Dosage Forms (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: Evelo Biosciences, Inc. | Recruiting ➔ Completed | N=24 ➔ 36

Enrollment change • Trial completion • Gastrointestinal Disorder

An Extension Trial in participants with Atopic Dermatitis who participated in previous trials with EDP1815 (clinicaltrialsregister.eu) - P2 | N=225 | Ongoing | Sponsor: EVELO Biosciences Inc

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Rheumatology

A Study Investigating the Effect of EDP1815 in the Treatment of Mild, Moderate and Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=405 | Recruiting | Sponsor: Evelo Biosciences, Inc. | N=300 ➔ 405 | Trial completion date: Nov 2022 ➔ Apr 2023 | Trial primary completion date: Oct 2022 ➔ Mar 2023

Enrollment change • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology