US-based AzurRx BioPharma has launched the European arm of its Phase IIb OPTION 2 clinical trial assessing MS1819 in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI).
Nine of the planned 15 global trial sites are currently active, including the initial European sites that are screening patients.
MS1819 is a recombinant lipase enzyme intended to treat EPI caused by cystic fibrosis and chronic pancreatitis. It is provided as an oral non-systemic biologic capsule.
The drug candidate is obtained from the Yarrowia lipolytica yeast lipase and works by breaking up fat molecules in the digestive tract of EPI patients in order to enable absorption as nutrients.
OPTION 2 is intended to evaluate the safety, tolerability and efficacy of 2.2g and 4.4g doses of MS1819 compared to the current standard of care, porcine pancreatic enzyme replacement therapy (PERT) pills.
On contrary to standard of care, the MS1819 synthetic lipase lacks animal products.
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The primary efficacy endpoint of the Phase IIb trial is the coefficient of fat absorption (CFA). The open-label, crossover study is designed to enrol a total of 30 CF patients aged 18 years and above across Europe and the US.
Participants will be given a 2.2g daily oral dose of MS1819 for three weeks or the PERT pills, where they take pre-study dose of PERT pills for three weeks.
MS1819 will be given in enteric capsules for gastric protection and optimal delivery of enzyme to the duodenum. Following three weeks of treatment, patients will be crossed over for an additional three weeks of alternative therapy.
A parallel group of patients will be analysed in the same fashion, using a 4.4g daily dose of MS1819. After completion of crossover treatments, patients will be followed for an another two weeks.
AzurRx CEO James Sapirstein said: “Our team is successfully advancing both of our MS1819 clinical programmes and actively initiating new clinical trial sites and screening and enrolling patients.
“We look forward to the successful completion of the OPTION 2 monotherapy trial and the combination therapy trial in 2021.”
Top-line results from the Phase IIb trial are expected in the first quarter of next year.