AzurRx BioPharma announces first patients dosed in MS1819-SD clinical trial
AzurRx BioPharma announced that it has dosed the first patients in its Phase 2 clinical trial to investigate MS1819-SD in combination with standard porcine enzyme replacement therapy for patients with cystic fibrosis who suffer from severe exocrine pancreatic insufficiency. This subset of CF patients experiences clinical symptoms of fat malabsorption, despite taking the maximum daily dose of PERTs. The Phase 2 multi-center study is designed to investigate the safety, tolerability and efficacy of escalating doses of MS1819-SD, which is a yeast-derived lipase, in conjunction with a stable dose of porcine PERTs, in order to increase the coefficient of fat absorption and relieve abdominal symptoms. A combination therapy of PERT and MS1819-SD has the potential to: correct macronutrient and micronutrient maldigestion; eliminate abdominal symptoms attributable to maldigestion; and sustain optimal nutritional status on a normal diet in CF patients with severe EPI. Planned enrollment is expected to include approximately 24 CF patients with severe EPI, with study completion anticipated in 2020.