AzurRx BioPharma has added two additional clinical trial sites in Poland to reduce any potential patient enrolment delays during the Covid-19 pandemic.
These two sites and the active clinical trial sites in the US are enrolling patients. Topline data is expected during the first quarter of this year.
AzurRx added the additional clinical sites for the extension arm of the Phase IIb OPTION 2 study which is investigating MS1819 immediate-release capsules to treat exocrine pancreatic insufficiency (EPI) in cystic fibrosis (CF) patients.
This arm has been designed to test immediate release capsules for identifying the optimal dose and delivery method of MS1819.
Patients aged 18 years or above who have completed the OPTION 2 crossover trial at higher dose levels relative to the previous OPTION 1 trial will be part of this arm.
Recently, the initial participants in the expansion arm were dosed and will be treated for two weeks.
The open-label, multi-centre, crossover OPTION 2 clinical trial will evaluate the safety, tolerability, and efficacy of MS1819 in a head-to-head comparison against the existing standard of care, porcine pancreatic enzyme replacement therapy (PERT) pills.
The coefficient of fat absorption (CFA) forms the trial’s primary efficacy endpoint.
AzurRx BioPharma president and CEO James Sapirstein said: “MS1819 has the potential to redefine the treatment of exocrine pancreatic insufficiency, a debilitating gastrointestinal condition common to patients with cystic fibrosis that can lead to a chronic nutritional deficiency.
“The recently initiated extension arm to the Phase IIb OPTION 2 trial provides the opportunity to investigate an immediate-release capsule formulation of MS1819, which we believe could offer important advantages to cystic fibrosis patients in their daily management of EPI.”