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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-SC1-2016-2017

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Sub call

H2020-SC1-2017-Two-Stage-RTD

Coordinator

ALGIPHARMA AS
Net EU contribution
€ 3 224 712,50
Address
Industriveien 33
1337 Sandvika
Norway

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Region
Norge Oslo og Viken Viken
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 6 150 000,00

Participants (7)

SMERUD MEDICAL RESEARCH INTERNATIONAL AS
Norway
Net EU contribution
€ 566 250,00
Address
Karenslyst Alle 6
0278 Oslo

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Norge Oslo og Viken Oslo
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

SMERUD MEDICAL RESEARCH GERMANY GMBH
Germany
Net EU contribution
€ 1 282 500,00
Address
O 7 1
68161 Mannheim

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Baden-Württemberg Karlsruhe Mannheim, Stadtkreis
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

SMERUD MEDICAL RESEARCH UK LIMITED
United Kingdom
Net EU contribution
€ 652 500,00
Address
Suite 1s-b Trafford House Chester Road Tretford
M32 0RS Manchester

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
North West (England) Greater Manchester Greater Manchester South West
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
KLINIKUM DER UNIVERSITAET ZU KOELN
Germany
Net EU contribution
€ 123 037,50
Address
Kerpener Strasse 62
50937 Koeln

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Region
Nordrhein-Westfalen Köln Köln, Kreisfreie Stadt
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
IMPERIAL COLLEGE OF SCIENCE TECHNOLOGY AND MEDICINE
United Kingdom
Net EU contribution
€ 79 990,00
Address
South Kensington Campus Exhibition Road
SW7 2AZ London

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Region
London Inner London — West Westminster
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
EUROPEAN CYSTIC FIBROSIS SOCIETY
Denmark
Net EU contribution
€ 52 258,75
Address
Kastanieparken 7
7470 Karup

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Region
Danmark Midtjylland Vestjylland
Activity type
Other
Non-EU contribution
€ 0,00
CYSTIC FIBROSIS EUROPE EV
Germany
Net EU contribution
€ 32 500,00
Address
In Den Dauen 6
53117 Bonn

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Region
Nordrhein-Westfalen Köln Bonn, Kreisfreie Stadt
Activity type
Other
Non-EU contribution
€ 0,00