OligoG-pivotal-CF: A multinational clinical project 
to test the orphan drug OligoG CF-5/20 in a 
pivotal phase 2b clinical trial for the treatment of cystic fibrosis.


GA no: 755234
Start date: 1 January 2018
Duration: 36 months

The drug:

  • OligoG is an alginate oligosaccharide derived from seaweed, and formulated as a dry powder for inhalation
  • OligoG is being developed to help CF patients clear stagnant mucus from their lungs
  • OligoG is anticipated to help slow the progression of the disease
  • OligoG has been shown to disrupt biofilms and increase antibiotic effectiveness

The main objectives:

  • Identify the optimal dose of OligoG
  • Document long-term safety and efficacy, with FEV1 as primary endpoint
  • Document the use of LCI as a valid efficacy endpoint

The study design:

  • Multi-center, randomized, double-blind, placebo controlled, parallel group study
    The study will comprise two parts:
    • Part 1: Comparison of 3 active drug dose groups and one placebo group
    • Part 2: 26 week randomized double blind placebo controlled study, followed by a 26 week open label study ensuring that all participants will have access to the active drug
  • The first part of the trial will include 120 CF patients from 35 European sites and 5 Australian sites

Consortium members:

  • University Hospital Cologne
  • Smerud Medical Research International AS
  • AlgiPharma AS
  • Imperial College London
  • European Cystic Fibrosis Society
  • Cystic Fibrosis Europe EV

Principal Investigator:

  • Dr. Silke van Koningsbruggen-Rietschel, University Hospital Cologne

Website:


This project has received funding from the European Union’s Horizon 2020 research and innovation programme “Health, demographic change and well-being” under grant agreement no 755234