AzurRx Reports Positive Topline Data for MS1819 Combination Therapy in Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency

AzurRx Reports Positive Topline Data for MS1819 Combination Therapy in Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency

AzurRx BioPharma announced results from its phase 2 trial evaluating MS1819 in combination with the current standard of care, porcine-derived pancreatic enzyme replacement therapy (PERT), for the treatment of severe exocrine pancreatic insufficiency in patients with cystic fibrosis (CF). The combination therapy achieved the primary endpoint, with data indicating clinically meaningful improvement in coefficient of fat absorption (CFA), as well as secondary outcome measure endpoints.

The Phase 2 multi-center study was designed to investigate the safety, tolerability, and efficacy of escalating doses of MS1819, administered in combination with a stable dose of PERT. Twenty patients, 12 years of age or older, with severe EPI were treated with escalating doses of MS1819 (700mg, 1200mg, and 2240mg) once daily for 15 days per dosing level, in addition to their standard PERT regimen. Baseline CFA levels were measured in patients receiving only standard of care therapy, before beginning combination therapy. From baseline, CFA increased by 6.57%, mean body weight increased by 3.75 pounds, stool weight decreased by 164 grams/day and the mean daily number of stools decr...

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