A Phase 1/2 study of EDP2939 in healthy volunteers and participants with moderate psoriasis

• Research type

  Research Study

• Full title

  Phase 1/2, randomised, placebo-controlled study of EDP2939 in healthy volunteers and participants with moderate plaque psoriasis.

• IRAS ID

  1005679

• Contact name

  Debbie Macaro

• Contact email

  dmacaro@evelobio.com

• Sponsor organisation

  Evelo Biosciences Inc.

• Eudract number

  2022-001631-82

• Research summary

  EDP2939 is a pharmaceutical preparation of EVs manufactured by fermentation and purification from a single strain of the parent bacterium, Prevotella histicola. This study will evaluate EDP2939 in healthy volunteers (Part A) followed by participants with moderate psoriasis (Part B) to determine safety and tolerability and preliminary efficacy. This is a randomised, placebo-controlled, Phase 1/2 study evaluating the safety, tolerability and clinical efficacy of EDP2939.
  Only Part A of the study will be conducted in a single-centre in the United Kingdom.
  Part A will enroll 36 healthy volunteers in 3 cohorts, receiving EDP2939 or placebo in oral polymer coated capsule(s) once a day for up to 10 days.

• REC name

  Wales REC 1

• REC reference

  22/WA/0274

• Date of REC Opinion

  29 Nov 2022

• REC opinion

  Further Information Favourable Opinion