Scintigraphic evaluation of EDP2939 oral dosage forms

• Research type

  Research Study

• Full title

  A Phase 1, single centre, open label, crossover study in healthy volunteers using scintigraphy to evaluate the gastrointestinal behaviour of EDP2939 oral dosage forms.

• IRAS ID

  1007114

• Contact name

  Nikia Trinward

• Contact email

  NTrinward@evelobio.com

• Sponsor organisation

  Evelo Bioscience Inc

• ISRCTN Number

  ISRCTN51560494

• Research summary

  Research Summary-
  This is a single-centre, open label, crossover design in up to 12 healthy male volunteers. This study will evaluate the in vivo release and gastrointestinal transit behaviour of up to four dosage forms, including EDP2939 capsules of different size and weight of polymer coating. EDP2939 is a pharmaceutical preparation of extracellular vesicles (EVs) of a single strain of Prevotella histicola bacteria, currently in clinical development for the treatment of psoriasis.
  
  The following treatments are being dosed throughout this study:
  Treatment A: Radiolabelled EDP2939 size 0 capsule with ~14mg polymer coating
  Treatment B: Radiolabelled EDP2939 size 2 capsule with ~6mg polymer coating
  Treatment C: Radiolabelled EDP2939 size 2 capsule with ~8mg polymer coating
  Treatment D: Radiolabelled EDP2939 size 2 capsule with ~10mg polymer coating

  Subjects will attend a maximum of 4 assessment visits and will be dosed with one of the study treatments in the fasted or fed states at each assessment visit.
  The primary purpose of this study is to understand the disintegration behaviour of the four formulations in vivo.
  In this study we will use scintigraphic imaging to visualise the gastric emptying of each treatment (when they leave the stomach) and confirm the site of release in the gastrointestinal tract. We will also use this technique to determine how quickly the treatment breaks up in the body. To look at these parameters we will add a small amount of radioactive material to the capsule.

  Summary of results-
  "The primary objective of this study was to assess the site and time to onset of disintegration with EDP2939 capsules of different size and coating weight in fasted and/or fed states. The following treatments were dosed during this study:
  Visit 1 : Treatment A: Radiolabelled EDP2939 size 0 capsule with ~14mg polymer coating (fed)
  Visit 2 :Treatment B: Radiolabelled EDP2939 size 2 capsule with ~6mg polymer coating (fed)
  Visit 3 :Treatment C: Radiolabelled EDP2939 size 2 capsule with ~8mg polymer coating (fed)
  Visit 4: Treatment C: Radiolabelled EDP2939 size 2 capsule with ~8mg polymer coating (fasted)

  Safety Results
  The study treatments were well tolerated by healthy volunteers with few adverse events reported overall and no serious adverse events. Of the 12 participants treated, six (50%) experienced at least one AE. A total of seven AEs were reported during the study, all of which were of mild severity and were not unexpected for a group of healthy volunteers. No clinically significant changes in vital signs (blood pressure and heart rate) or ECGs were observed.

  Scintigraphic Results
  Gastric emptying times fell within expected ranges for both the fed and fasted states. The median onset of tablet release was observed within 15 minutes of gastric emptying for all treatments in the fed state with the majority confirmed to release in the proximal regions of the small intestine. Following onset of release, there was no notable difference between the release kinetics of Treatment B and C, whether in the fed or fasted state."

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  23/LO/0035

• Date of REC Opinion

  6 Mar 2023

• REC opinion

  Further Information Favourable Opinion