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Notification about study halt and redesign

The recent news about the EU approval of Kaftrio is truly great news for the many people with cystic fibrosis (CF) who will be eligible for treatment with this new drug.

It was anticipated that the first part of the “OligoG Pivotal CF” study would have been completed before Kaftrio became widely available, thereby avoiding any subsequent challenges in recruiting sufficient patients to this “modulator-free” trial.

However, since so many people with CF will now be eligible and have access to Kaftrio treatment, it is considered unlikely that the OligoG study would meet the recruitment target within the countries currently enlisted in the study. Therefore, it was decided to halt the trial prior to any recruitment and redesign the study in light of the changing CF therapeutic landscape.

AlgiPharma and the clinical investigators in the study consortium are now working together to prepare a new trial design that best accommodates this rapidly changing landscape, while maximizing the opportunity to develop new therapeutics to improve the health of all persons with CF worldwide.

The trial consortium would like to thank all investigators and clinical trial teams for the considerable effort and investment so far and look forward to restarting later this year.

OligoGpivotalCF and Covid-19: AlgiPharma CF Clinical Trial Operations in Europe

We have now received regulatory approvals from Austria, UK, Germany and Ireland, and ethics approvals from Austria and UK. Ethics approvals from Germany and Ireland are expected to follow soon in order for us to proceed with the OligoGpivotalCF clinical study.

However, due to the current situation with COVID-19, we have decided to postpone site initiation visits until after April 12 (Easter break) to minimize the risk for the CF community.

The Cystic Fibrosis Foundation (CFF) has recently issued guidance, based on recommendations from the US CDC and local health authorities, which we believe is also prudent to adopt here.

See also https://www.cff.org/Life-With-CF/Daily-Life/Germs-and-Staying-Healthy/What-Are-Germs/COVID-19-Community-Questions-and-Answers/