OligoG: 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.
For more general information about the project, see the OligoG website.