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PES2020-Prosj.etabl.støtte H2020

OligoG for the treatment of adult and pediatric cystic fibrosis.

Awarded: NOK 0.20 mill.

The backbone of the project will be the pivotal phase 3 clinical trial; probably including some 150-300 patients from 20-50 sites all over Europe, followed by the compilation of the Marketing Authorisation Application, and its subsequent submission to EMA for approval. All other work packages and tasks are geared towards documenting the efficacy and safety/tolerability of OligoG for treatment of cystic fibrosis. The subprojects are also of high interest to the R&D community as such, as we will be addre ssing secondary endpoints and support the development, and clinical-regulatory validation of those. Overall, the project plan is currently composed of about 10 main Work Packages: 1. CONSORTIUM MANAGEMENT AND EU REPORTING 2. COMMERCIALISATION PLAN 3. REG ULATORY AGENCY AND SOCIETY CONSULTATIONS 4. NON-CLINICAL TOXICOLOGY STUDIES 5. PIVOTAL CONFIRMATORY CLINICAL PHASE 3 TRIAL 6. SAFETY AND PHARMACOVIGILANCE PROGRAMME 7. HEALTH ECONOMICS AND PRICING 8. MARKETING AUTHORISATION APPLICATION 9. PEDIATRIC INVE STIGATIVE PLAN 10. COMPASSIONATE USE PROGRAMME

Funding scheme:

PES2020-Prosj.etabl.støtte H2020