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EDP1815

Phase 2

Atopic Dermatitis | Small Molecules | Dermatology |Evelo Biosciences, Inc.|Trials Updated: Aug 16, 2023

EDP1815 development status

Highest phase Phase 2
Registered trials 6 across 1 sponsor since Nov 2018

EDP1815 target and mechanism

ModalitySmall Molecules

Also known as EDP1815 tablet, Prevotella histicola

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials4
Total Enrollment912

FDA Designations

No designations recorded

EDP1815 clinical trials

EDP1815 · 4 trials · 4 indications

Phase 2 2Phase 1 2
NCT05121480A Study Investigating the Effect of EDP1815 in the Treatment of Mild, Moderate and Severe Atopic DermatitisAtopic Dermatitis
COMPLETED421 Analytics
NCT04603027A Phase 2 Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque PsoriasisPsoriasis
COMPLETED249 Analytics
PHASE2COMPLETED
A Study Investigating the Effect of EDP1815 in the Treatment of Mild, Moderate and Severe Atopic Dermatitis
Atopic DermatitisUnlock trial analytics
PHASE2COMPLETED
A Phase 2 Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis
PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

Achievement of EASI-50
16 weeks

The efficacy of EDP1815 will be measured by achieving a decrease of at least 50% from baseline in Eczema Area Severity Index (EASI) score of 50 (EASI-50) at Week 16. The EASI is a validated measure of eczema severity, which considers a combination of the disease severity and body surface area affected across 4 body regions. The EASI score ranges from 0 - 72. A lower score indicates a better outcome.

Mean Percentage Change in PASI
16 weeks

The Psoriasis Area and Severity Index Score (PASI) is a physician assessment that combines the assessment of the severity of and area affected by psoriasis into a single score in the range 0 (no disease) to 72 (maximal disease).The efficacy of EDP1815 will be measured using the mean percentage change in PASI from baseline to week 16.

KLH-induced immune reaction.
At 24 hours after Day 57 intradermal re-challenge.

This will be measured as basal flow (arbitrary units, AU) by LSCI.

Safety and tolerability measured through Adverse Events (AEs)
Day 1 to Day 70

Number of participants with AEs by seriousness and relationship to treatment

Safety and tolerability measured through lab measurements
Day 0 to Day 70

Number of participants with clinically significant change from baseline (Day 0) in laboratory values

Safety and tolerability measured through ECG
Day 0 to Day 70

Number of participants with clinically relevant changes from baseline (Day 0) ECG parameters

Safety and tolerability measured through physical examination
Day 0 to Day 60

Physical examination of stool samples based on the Bristol Stool Scale (Types 3 and 4 are ideal stool): Type 1: Separate hard lumps, like nuts (hard to pass); Type 2: Sausage-shaped, but lumpy; Type 3: Like a sausage but with cracks on its surface; Type 4: Like a sausage or snake, smooth and soft; Type 5: Soft blobs with clear cut edges (easy to pass); Type 6: Fluffy pieces with ragged edges, a mushy stool; Type 7: Watery, no solid pieces, entirely liquid

GI safety measurement through biomarker analysis
Day 0 to Day 60

GI safety measurement through fecal calprotectin analysis

Secondary Endpoints

Percentage of Participants Achieving EASI-50
4, 8 and 12 weeks
Percentage of Participants Achieving EASI-75
4, 8, 12, and 16 weeks
Percentage of Participants Achieving EASI-90
4, 8, 12, and 16 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTAL100 participants with mild, moderate or severe Atopic Dermatitis 75 participants on EDP1815 and 25 participants on matching placebo administered as 2 capsules (1.6 x 10\^11 total cells) once daily for 16 weeks
Cohort 2EXPERIMENTAL100 participants with mild, moderate or severe Atopic Dermatitis 75 participants on EDP1815 and 25 participants on matching placebo administered as 2 capsules (6.4 x 10\^11 total cells) once daily for 16 weeks
Cohort 3EXPERIMENTAL100 participants with mild, moderate or severe Atopic Dermatitis 75 participants on EDP1815 and 25 participants on matching placebo administered as 1 capsule (3.2 x 10\^11 cells) twice daily (6.4 x 10\^11 total cells) for 16 weeks
Cohort 4EXPERIMENTAL105 participants with mild, moderate or severe Atopic Dermatitis 70 participants on EDP1815 and 35 participants on matching placebo administered at 1 capsule (8.0x10\^10 total cells) once daily for 16 weeks
Cohort 5OTHER24 subjects with mild to moderate atopic dermatitis; 16 on EDP1815, 8 on placebo. Dose= 5 x HED, mini-tablets in capsule, once daily, 29 days
Cohort 6OTHER24 subjects with mild to moderate psoriasis; 16 on EDP1815, 8 on placebo. Dose=5 x HED, mini-tablets in capsule, once daily, 29 days.
Cohort 7OTHER24 subjects with mild to moderate atopic dermatitis; 16 on EDP1815, 8 on placebo. Dose= 5 x HED, capsule, once daily, 56 days
Cohort 8OTHER24 subjects with mild to moderate psoriasis; 16 on EDP1815, 8 on placebo. Dose= 8 x HED, tablet, once daily, 56 days
Cohort 9OTHER24 subjects with mild to moderate psoriasis; 16 on EDP1815, 8 on placebo. Dose= 2 x HED, capsule, once daily, 56 days
Cohort 10OTHER24 subjects with mild to moderate atopic dermatitis; 16 on EDP1815, 8 on placebo. Dose= 4 x HED, capsule, once daily, 56 days

Interventions

NameTypeDescription
EDP1815DRUGEDP1815 is an orally administered, pharmaceutical preparation of a single strain of bacteria
PlaceboDRUGPlacebo oral capsule
EDP2939DRUGEDP2939 is a pharmaceutical preparation of extracellular vesicles.
Placebo oral capsuleDRUGPlacebo.
Placebo oral tabletDRUGPlacebo
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites59

Inclusion Criteria: * Provide written informed consent. * Must meet age criteria. * Must have a diagnosis of atopic dermatitis (AD)for at least 6 months. * Must have severity of atopic dermatitis meeting the below criteria at both Screening and Day 1: * An IGA of 2, 3 or 4 on the vIGA scale, and...

Countries:United StatesAustraliaBulgariaCanadaGermanyPolandHungaryUnited KingdomNetherlands
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