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A pivotal phase IIb clinical trial of inhaled alginate oligosaccharide (OligoG) for cystic fibrosis

Objective

The objective of the current proposal is to advance the orphan drug OligoG CF-5/20 (OligoG) through a pivotal phase IIb clinical trial, to enable a new and improved therapeutic approach for the orphan disease cystic fibrosis by 2024.

The study drug is an alginate oligosaccharide derived from seaweed. Several properties relevant to the treatment of CF have been demonstrated using in vitro and ex vivo model systems including release of stagnant mucus, disruption of bacterial biofilm and increased bacterial susceptibility to antibiotics. OligoG received an EU Orphan Drug Medicinal Product Designation in 2007 and an FDA Orphan Drug Designation February 2016, for the treatment of cystic fibrosis.

The planned clinical trial will include approx 200 CF patients from approx. 35 European sites in coordination with the European Clinical Trial Network. The final study design, selection criteria, procedures and endpoints will be based on results from a recently finalized phase II study and will follow scientific advice and protocol assistance sought at the European Medicines Agency (EMA). A set of clinical and exploratory endpoints will be defined to assess the various effects of OligoG, comprising lung function assessed by spirometry and Lung Clearance Index (LCI) measurements, infection status assessed by frequency of pulmonary exacerbations and non-culture-dependent microbiology, and patient reported outcomes assessed by questionnaires, including standardised CF questionnaires (CFQ-R).


A successful trial will enable preparation of international applications for conditional marketing authorisation (cMAA) throughout Europe and a New Drug Application (NDA) in the US, for the treatment of cystic fibrosis lung disease. In accordance with the work programme, a successful project will thus imply a new and improved therapeutic approach within cystic fibrosis available for CF patients by 2024.

Call for proposal

H2020-SC1-2017-Two-Stage-RTD
See other projects for this call

Coordinator

ALGIPHARMA AS
Address
Industriveien 33
1337 Sandvika
Norway
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EU contribution
€ 3 224 712,50

Participants (5)

SMERUD MEDICAL RESEARCH INTERNATIONAL AS
Norway
EU contribution
€ 2 501 250
Address
Karenslyst Alle 6
0278 Oslo
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
KLINIKUM DER UNIVERSITAET ZU KOELN
Germany
EU contribution
€ 123 037,50
Address
Kerpener Strasse 62
50937 Koeln
Activity type
Higher or Secondary Education Establishments
IMPERIAL COLLEGE OF SCIENCE TECHNOLOGY AND MEDICINE
United Kingdom
EU contribution
€ 79 990
Address
South Kensington Campus Exhibition Road
SW7 2AZ London
Activity type
Higher or Secondary Education Establishments
EUROPEAN CYSTIC FIBROSIS SOCIETY
Denmark
EU contribution
€ 52 258,75
Address
Kastanieparken 7
7470 Karup
Activity type
Other
CYSTIC FIBROSIS EUROPE EV
Germany
EU contribution
€ 32 500
Address
In Den Dauen 6
53117 Bonn
Activity type
Other