Evaluation of the Immunopharmacology of EDP1815 and EDP2939

Evelo Biosciences

Status and phase: Completed; Phase 1

Conditions: KLH and Imiquimod Induced Skin Inflammation in Healthy Volunteers

Treatments: Drug: EDP1815; Drug: EDP2939; Drug: Placebo oral capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT05682222

EDP1815-105

Details and patient eligibility

About

A single-center, randomized, double-blind, placebo-controlled, multiple dose platform trial.

Full description

This study will evaluate the pharmacodynamic effects of multiple doses of EDP1815 and EDP2939 on immunological responses to keyhole limpet hemocyanin (KLH) and imiquimod (IMQ) dermal challenges in healthy volunteers.

EDP1815 is an essentially non-live, specific strain of Prevotella histicola, a natural human commensal organism. EDP2939 is a pharmaceutical preparation of microbial extracellular vesicles.

Four cohorts of volunteers (n=18 per cohort) will be studied using different capsule formulations and doses, administered for 60 days. Volunteers will be immunised with intramuscular KLH. Intradermal KLH re-challenge and topical IMQ challenge will commence on Day 57 with serial pharmacodynamic assessments to Day 60. Responses will be evaluated using dermal imaging (laser speckled contrast imaging; LSCI, and multi-spectral photography), as well as dermal and systemic immunological biomarkers.

Enrollment: 38 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Capable of giving signed informed consent, and willing to comply with requirements of the study.
• Age 18 years to 45 years, inclusive.
• Body mass index of 18 to 35 kg/m2, inclusive.
• Caucasian.
• Healthy based on medical history, physical examination, blood pressure, ECG and blood and urine laboratory tests.

Key Exclusion Criteria:

• Use of Aldara® (imiquimod cream) within 3 weeks prior to the study.
• Has previously received Immucothel® or KLH.
• Allergy to Alhydrogel® or Aldara® (imiquimod cream).
• Current or recurrent skin diseases affecting the arms or back, or extensive tattoos in these areas.
• Previous diagnosis of psoriasis.
• History of pathological scar formation (e.g. keloid scar).
• History of skin cancer (basal cell carcinoma, squamous cell carcinoma, melanoma).
• Significant bowel disease (e.g. inflammatory bowel disease, coeliac disease)
• Currently has an infection or has needed antibiotics within 6 weeks before the study.
• Current smoker of more than 5 cigarettes per day
• Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks before start of the study
• History of Schistosomiasis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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38 participants in 4 patient groups

Cohort 1

Other group

Description:

EDP1815 or placebo in capsule A, dosed for 60 days. Randomization is 2:1 active:placebo.

Treatment:

Drug: EDP1815

Drug: Placebo oral capsule

Cohort 2

Other group

Description:

EDP1815 or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo.

Treatment:

Drug: EDP1815

Drug: Placebo oral capsule

Cohort 3

Other group

Description:

EDP2939 lower dose or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo.

Treatment:

Drug: EDP2939

Drug: Placebo oral capsule

Cohort 4

Other group

Description:

EDP2939 higher dose or placebo in capsule B, dosed for 60 days. Randomization is 2:1 active:placebo.

Treatment:

Drug: EDP2939

Drug: Placebo oral capsule