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
AlgiPharma and the clinical investigators in the study consortium have paused further preparations and stopped the HORIZON2020 project prematurely
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:
- www.OligoGpivotalCF.eu
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