- |||||||||| EDP1503 / Evelo Biosci, Keytruda (pembrolizumab) / Merck (MSD)
Enrollment closed, Metastases: Pembrolizumab and EDP1503 in Advanced Melanoma (clinicaltrials.gov) - Jul 31, 2024 P2, N=8, Active, not recruiting, Suspended --> Active, not recruiting
- |||||||||| EDP1815 / Evelo Biosci
Clinical, P2 data, Journal, Immunomodulating: 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 Central) - May 30, 2024 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.
- |||||||||| EDP1503 / Evelo Biosci, Keytruda (pembrolizumab) / Merck (MSD)
Trial completion date, Trial primary completion date, Metastases: Pembrolizumab and EDP1503 in Advanced Melanoma (clinicaltrials.gov) - Jan 28, 2024 P2, N=8, Suspended, and tumour necrosis factor in blister fluid of EDP1815-treated participants. Trial completion date: Nov 2023 --> Nov 2027 | Trial primary completion date: Nov 2023 --> Nov 2027
- |||||||||| EDP1815 / Evelo Biosci
Journal: Clinical translation of anti-inflammatory effects of Prevotella histicola in Th1, Th2, and Th17 inflammation. (Pubmed Central) - May 22, 2023 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.
- |||||||||| EDP1815 / Evelo Biosci, EDP2939 / Evelo Biosci
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: Evaluation of the Immunopharmacology of EDP1815 and EDP2939 (clinicaltrials.gov) - May 19, 2023 P1, N=38, Completed, 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. Recruiting --> Completed | N=72 --> 38 | Trial completion date: Apr 2023 --> Oct 2022 | Trial primary completion date: Apr 2023 --> Oct 2022
- |||||||||| EDP1815 / Evelo Biosci
Enrollment closed, Trial completion date, Trial primary completion date: A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous EDP1815 Trials (clinicaltrials.gov) - May 6, 2023 P2, N=287, Active, not recruiting, Recruiting --> Completed | N=72 --> 38 | Trial completion date: Apr 2023 --> Oct 2022 | Trial primary completion date: Apr 2023 --> Oct 2022 Enrolling by invitation --> Active, not recruiting | Trial completion date: Feb 2024 --> May 2023 | Trial primary completion date: Dec 2023 --> May 2023
- |||||||||| EDP1503 / Evelo Biosci, Keytruda (pembrolizumab) / Merck (MSD)
Trial primary completion date, Metastases: Pembrolizumab and EDP1503 in Advanced Melanoma (clinicaltrials.gov) - Apr 28, 2023 P2, N=8, Suspended, Enrolling by invitation --> Active, not recruiting | Trial completion date: Feb 2024 --> May 2023 | Trial primary completion date: Dec 2023 --> May 2023 Trial primary completion date: Nov 2022 --> Nov 2023
- |||||||||| EDP1867 / Evelo Biosci
Trial completion, Enrollment change, Trial completion date: EDP1867-101: Study in Healthy Participants and Participants With Moderate Atopic Dermatitis & Optionally, Moderate Psoriasis, and/or Mild Asthma (clinicaltrials.gov) - Oct 7, 2022 P1, N=52, Completed, Recruiting --> Active, not recruiting Active, not recruiting --> Completed | N=96 --> 52 | Trial completion date: May 2022 --> Feb 2022
- |||||||||| EDP1815 / Evelo Biosci
Enrollment open, Enrollment change, Trial completion date, Trial initiation date, Trial primary completion date: Scintigraphy Study to Evaluate the Gastrointestinal Behavior of EDP1815 Oral Dosage Forms (clinicaltrials.gov) - Jul 21, 2022 P1, N=48, Recruiting, Recruiting --> Active, not recruiting 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
- |||||||||| EDP1867 / Evelo Biosci
Journal: Regulation of Peripheral Inflammation by a Non-Viable, Non-Colonizing Strain of Commensal Bacteria. (Pubmed Central) - Mar 29, 2022 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.
- |||||||||| EDP1867 / Evelo Biosci
Enrollment closed: EDP1867-101: Study in Healthy Participants and Participants With Moderate Atopic Dermatitis & Optionally, Moderate Psoriasis, and/or Mild Asthma (clinicaltrials.gov) - Mar 2, 2022 P1, N=96, Active, not recruiting, 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. Recruiting --> Active, not recruiting
- |||||||||| EDP1503 / Evelo Biosci
Trial completion, Enrollment change, Trial completion date, Trial primary completion date, Checkpoint inhibition, Metastases: KEYNOTE-939: A Study of EDP1503 in Patients With Colorectal Cancer, Breast Cancer, and Checkpoint Inhibitor Relapsed Tumors (clinicaltrials.gov) - Nov 12, 2021 P1/2, N=69, Completed, Phase classification: P1a/1b --> P1 | Trial completion date: Nov 2021 --> May 2022 | Trial primary completion date: Sep 2021 --> Apr 2022 Recruiting --> Completed | N=120 --> 69 | Trial completion date: Dec 2020 --> Oct 2021 | Trial primary completion date: Dec 2020 --> Jun 2021
- |||||||||| EDP1503 / Evelo Biosci, Keytruda (pembrolizumab) / Merck (MSD)
Enrollment change, Trial suspension, Trial primary completion date, Metastases: Pembrolizumab and EDP1503 in Advanced Melanoma (clinicaltrials.gov) - Jun 30, 2021 P2, N=8, Suspended, 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. N=70 --> 8 | Active, not recruiting --> Suspended | Trial primary completion date: Nov 2021 --> Nov 2022
- |||||||||| EDP2939 / Evelo Biosci
[VIRTUAL] Orally-delivered microbial extracellular vesicle induces anti-inflammatory activity in mice () - May 19, 2021 - Abstract #IMMUNOLOGY2021IMMUNOLOGY_2333; We now extend these observations to EDP2939, a bacterial extracellular vesicle (EV), that has potent anti-inflammatory activity in preclinical models...EVs are particularly effective at engaging host cells in the gut to modulate distal inflammation. These data point to oral EVs as a new class of immunotherapeutic drugs.
- |||||||||| EDP1815 / Evelo Biosci, Abdul Latif Jameel Health
ATOPIC DERMATITIS PHASE 1B POSITIVE TRIAL RESULTS FOR EDP1815, AN ORAL SINGLESTRAIN COMMENSAL MICROBE () - Apr 23, 2021 - Abstract #ISAD2021ISAD_151; At the day 70 follow-up, the percentage of patients receiving EDP1815 achieving EASI50 was 44% compared with 0% in the placebo group; and the proportion achieving an IGA score of 0 or 1 was 31%, again compared with 0% in the placebo group. The phase 1b clinical data presented provide proof of concept for further clinical development of EDP1815 in the treatment of atopic dermatitis.
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