Trial Outcomes & Findings for A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous EDP1815 Trials (NCT NCT05439941)

NCT ID: NCT05439941

Last Updated: 2023-09-07

Results Overview

The long-term safety and tolerability of EDP1815 in the treatment of atopic dermatitis will be measured by evaluating the incidence and rate per 100 patient-years of treatment-emergent adverse events during the 36-week treatment period and the 4-week follow-up period of this study, and during the treatment period of this study and the relevant parent study.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 287 participants
• Primary outcome timeframe: 40 weeks
• Results posted on: 2023-09-07

Participant Flow

Participant milestones

Measure	Group 1 Participants with mild, moderate or severe Atopic Dermatitis who received 2 capsules (1.6 x 10\^11 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily.	Group 2 Participants with mild, moderate or severe Atopic Dermatitis who received 2 capsules (6.4 x 10\^11 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily.	Group 3 Participants with mild, moderate or severe Atopic Dermatitis who received 1 capsule (8.0 x 10\^10 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily.
Overall Study STARTED	104	102	79
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	104	102	79

Reasons for withdrawal

Measure	Group 1 Participants with mild, moderate or severe Atopic Dermatitis who received 2 capsules (1.6 x 10\^11 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily.	Group 2 Participants with mild, moderate or severe Atopic Dermatitis who received 2 capsules (6.4 x 10\^11 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily.	Group 3 Participants with mild, moderate or severe Atopic Dermatitis who received 1 capsule (8.0 x 10\^10 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily.
Overall Study Lack of Efficacy	8	5	3
Overall Study Treatment Failure	0	1	0
Overall Study Adverse Event	1	3	0
Overall Study Adverse Event - Parent Study	1	0	0
Overall Study Pregnancy	1	0	0
Overall Study Withdrawal by Subject	9	6	10
Overall Study Non-Compliance	1	1	1
Overall Study Lost to Follow-up	2	2	0
Overall Study Physician Decision	1	0	0
Overall Study Trial Termination by Sponsor	78	83	65
Overall Study Other than Reasons Listed	2	1	0

Baseline Characteristics

A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous EDP1815 Trials

Baseline characteristics by cohort

Measure	Group 1 n=104 Participants Participants with mild, moderate or severe Atopic Dermatitis who received 2 capsules (1.6 x 10\^11 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily.	Group 2 n=102 Participants Participants with mild, moderate or severe Atopic Dermatitis who received 2 capsules (6.4 x 10\^11 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily.	Group 3 n=79 Participants Participants with mild, moderate or severe Atopic Dermatitis who received 1 capsule (8.0 x 10\^10 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily.	Total n=285 Participants Total of all reporting groups
Age, Continuous	40.0 years STANDARD_DEVIATION 16.28 • n=5 Participants	40.6 years STANDARD_DEVIATION 14.05 • n=7 Participants	39.4 years STANDARD_DEVIATION 14.66 • n=5 Participants	40.0 years STANDARD_DEVIATION 15.02 • n=4 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	49 Participants n=7 Participants	45 Participants n=5 Participants	147 Participants n=4 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	53 Participants n=7 Participants	34 Participants n=5 Participants	138 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	13 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	97 Participants n=5 Participants	98 Participants n=7 Participants	74 Participants n=5 Participants	269 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants	12 Participants n=7 Participants	10 Participants n=5 Participants	33 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	26 Participants n=4 Participants
Race (NIH/OMB) White	81 Participants n=5 Participants	77 Participants n=7 Participants	56 Participants n=5 Participants	214 Participants n=4 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Region of Enrollment Canada	19 participants n=5 Participants	22 participants n=7 Participants	20 participants n=5 Participants	61 participants n=4 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	19 participants n=5 Participants	69 participants n=4 Participants
Region of Enrollment Poland	30 participants n=5 Participants	25 participants n=7 Participants	29 participants n=5 Participants	84 participants n=4 Participants
Region of Enrollment Australia	4 participants n=5 Participants	4 participants n=7 Participants	1 participants n=5 Participants	9 participants n=4 Participants
Region of Enrollment Bulgaria	18 participants n=5 Participants	16 participants n=7 Participants	7 participants n=5 Participants	41 participants n=4 Participants
Region of Enrollment Germany	8 participants n=5 Participants	10 participants n=7 Participants	3 participants n=5 Participants	21 participants n=4 Participants

PRIMARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The long-term safety and tolerability of EDP1815 in the treatment of atopic dermatitis will be measured by evaluating the incidence and rate per 100 patient-years of treatment-emergent adverse events during the 36-week treatment period and the 4-week follow-up period of this study, and during the treatment period of this study and the relevant parent study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following EASI endpoints:

• Percentage of participants achieving EASI-50

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following EASI endpoints:

• Percentage of participants achieving EASI-75

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following EASI endpoints:

• Percentage of participants achieving EASI-90

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following EASI endpoints:

• Mean absolute change from baseline in EASI Score

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following EASI endpoints:

• Mean percentage change from baseline in EASI Score

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA endpoints:

• Percentage of participants achieving IGA of 0 or 1 with a ≥2 point improvement from baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA endpoints:

• Percentage of participants achieving IGA of 0 or 1

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA endpoints:

• Percentage of participants achieving IGA of 0

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA *BSA endpoints:

• Mean absolute change from baseline in IGA*BSA

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA *BSA endpoints:

• Mean percentage change from baseline in IGA*BSA

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA *BSA endpoints:

• Mean absolute change from baseline in BSA

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA *BSA endpoints:

• Mean percentage change from baseline in BSA

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA *BSA endpoints:

• Percentage of participants achieving BSA-50

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following BSA endpoints:

• Percentage of participants achieving BSA-75

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following IGA *BSA endpoints:

• Percentage of participants achieving BSA reduction to 3% or less

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SCORAD endpoints:

• Mean absolute change from baseline in SCORAD

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SCORAD endpoints:

• Mean percentage change from baseline in SCORAD

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SCORAD endpoints:

• Percentage of participants achieving SCORAD-50

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SCORAD endpoints:

• Percentage of participants achieving SCORAD-75

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following DLQI endpoints:

• Mean absolute change from baseline in DLQI

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following DLQI endpoints:

• Mean percentage change from baseline in DLQI

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following DLQI endpoints:

• Percentage of participants achieving a reduction of ≥4 in the DLQI, of those with a score of ≥4 at baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following PP-NRS endpoints:

• Mean absolute change from baseline in PP-NRS

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following PP-NRS endpoints:

• Percentage of participants achieving a reduction of ≥2 in the PP-NRS, of those with a score of ≥2 at baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following PP-NRS endpoints:

• Percentage of participants achieving a reduction of ≥4 in the PP-NRS, of those with a score of ≥4 at baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SD-NRS endpoints:

• Mean absolute change from baseline in SD-NRS

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following SD-NRS endpoints:

• Percentage of participants achieving a reduction of ≥2 in the SD NRS, of those with a score of ≥2 at baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following POEM endpoints:

• Mean absolute change from baseline in Patient Oriented Eczema Measure (POEM)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following POEM endpoints:

• Mean percentage change from baseline in Patient Oriented Eczema Measure (POEM)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following POEM endpoints:

• Percentage of participants achieving a reduction of ≥4 in the POEM score, of those with a score of ≥4 at baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following Rescue therapy use endpoints:

• Number of courses per patient-year of any rescue medication (not including antibacterial therapy)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following Rescue therapy use endpoints:

• Number of courses per patient-year of topical corticosteroids of any potency

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following Rescue therapy use endpoints:

• Number of courses per patient-year of topical tacrolimus (0.1%), topical pimecrolimus

(1%) or grade VII topical corticosteroid

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 40 weeks

Population: No participants reached the Week 40 timepoint for inclusion in the analysis as the study was terminated (halted early) as Parent Study (NCT05121480) did not meet the primary endpoint.

The efficacy of long-term treatment with EDP1815 in the treatment of Atopic Dermatitis will be measured using the following Rescue therapy use endpoints:

• Number of courses per patient year of moderate potency (grade IV and V) topical steroids

Outcome measures

Outcome data not reported

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Group 2

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Group 3

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1 n=104 participants at risk Participants with mild, moderate or severe Atopic Dermatitis who received 2 capsules (1.6 x 10\^11 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily.	Group 2 n=102 participants at risk Participants with mild, moderate or severe Atopic Dermatitis who received 2 capsules (6.4 x 10\^11 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily.	Group 3 n=79 participants at risk Participants with mild, moderate or severe Atopic Dermatitis who received 1 capsule (8.0 x 10\^10 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily.
Vascular disorders Hypertension Exacerbation	0.00% 0/104 • Adverse events (AEs) were collected from informed consent, during the treatment period (110 days on average) and through an additional 28 days after taking their last dose of study drug.	0.98% 1/102 • Number of events 1 • Adverse events (AEs) were collected from informed consent, during the treatment period (110 days on average) and through an additional 28 days after taking their last dose of study drug.	0.00% 0/79 • Adverse events (AEs) were collected from informed consent, during the treatment period (110 days on average) and through an additional 28 days after taking their last dose of study drug.
Pregnancy, puerperium and perinatal conditions Abortion Spontaneous	0.00% 0/104 • Adverse events (AEs) were collected from informed consent, during the treatment period (110 days on average) and through an additional 28 days after taking their last dose of study drug.	0.00% 0/102 • Adverse events (AEs) were collected from informed consent, during the treatment period (110 days on average) and through an additional 28 days after taking their last dose of study drug.	1.3% 1/79 • Number of events 1 • Adverse events (AEs) were collected from informed consent, during the treatment period (110 days on average) and through an additional 28 days after taking their last dose of study drug.

Other adverse events

Measure	Group 1 n=104 participants at risk Participants with mild, moderate or severe Atopic Dermatitis who received 2 capsules (1.6 x 10\^11 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily.	Group 2 n=102 participants at risk Participants with mild, moderate or severe Atopic Dermatitis who received 2 capsules (6.4 x 10\^11 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily.	Group 3 n=79 participants at risk Participants with mild, moderate or severe Atopic Dermatitis who received 1 capsule (8.0 x 10\^10 total cells) of EDP1815 (an orally administered, pharmaceutical preparation of a single strain of bacteria) once daily.
Infections and infestations Nasopharyngitis	8.7% 9/104 • Number of events 12 • Adverse events (AEs) were collected from informed consent, during the treatment period (110 days on average) and through an additional 28 days after taking their last dose of study drug.	5.9% 6/102 • Number of events 8 • Adverse events (AEs) were collected from informed consent, during the treatment period (110 days on average) and through an additional 28 days after taking their last dose of study drug.	0.00% 0/79 • Adverse events (AEs) were collected from informed consent, during the treatment period (110 days on average) and through an additional 28 days after taking their last dose of study drug.
Infections and infestations Upper respiratory tract infection	3.8% 4/104 • Number of events 5 • Adverse events (AEs) were collected from informed consent, during the treatment period (110 days on average) and through an additional 28 days after taking their last dose of study drug.	6.9% 7/102 • Number of events 10 • Adverse events (AEs) were collected from informed consent, during the treatment period (110 days on average) and through an additional 28 days after taking their last dose of study drug.	3.8% 3/79 • Number of events 3 • Adverse events (AEs) were collected from informed consent, during the treatment period (110 days on average) and through an additional 28 days after taking their last dose of study drug.
Infections and infestations COVID-19	7.7% 8/104 • Number of events 8 • Adverse events (AEs) were collected from informed consent, during the treatment period (110 days on average) and through an additional 28 days after taking their last dose of study drug.	2.9% 3/102 • Number of events 3 • Adverse events (AEs) were collected from informed consent, during the treatment period (110 days on average) and through an additional 28 days after taking their last dose of study drug.	1.3% 1/79 • Number of events 1 • Adverse events (AEs) were collected from informed consent, during the treatment period (110 days on average) and through an additional 28 days after taking their last dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis atopic	7.7% 8/104 • Number of events 12 • Adverse events (AEs) were collected from informed consent, during the treatment period (110 days on average) and through an additional 28 days after taking their last dose of study drug.	5.9% 6/102 • Number of events 7 • Adverse events (AEs) were collected from informed consent, during the treatment period (110 days on average) and through an additional 28 days after taking their last dose of study drug.	1.3% 1/79 • Number of events 1 • Adverse events (AEs) were collected from informed consent, during the treatment period (110 days on average) and through an additional 28 days after taking their last dose of study drug.

Additional Information

Duncan McHale, MBBS, MRCP, PhD

Evelo Biosciences, Inc

Phone: +447500128938

Email: duncan@evelobio.com

Results disclosure agreements

• Principal investigator is a sponsor employee After completion of the study, the data may be considered for reporting at a scientific meeting or for publication in a scientific journal. The sponsor has final approved authority over publication of the study data.
• Publication restrictions are in place

Restriction type: OTHER