AZRX - AzurRx reports clinically meaningful effect in condition linked to cystic fibrosis

AzurRx BioPharma (AZRX) said that its experimental therapy MS1819 led to clinically meaningful improvements in the primary efficacy endpoint in a Phase 2 trial for the treatment of severe exocrine pancreatic insufficiency ((EPI)) in patients with cystic fibrosis ((CF)). The multi-center study was designed to evaluate the safety, tolerability, and efficacy of escalating doses of MS1819 in combination with a stable dose of porcine-derived pancreatic enzyme replacement therapy ((PERT)).Based on interim results from the study that enrolled 20 patients, the combo has led to clinically meaningful improvements in the primary efficacy endpoint of improvement in Coefficient of Fat Absorption ((CFA)) with an average gain of 5.9 points from baseline.A five-point improvement in CFA is considered clinically significant, AzurRx said citing medical literature.“We expect to report full topline results from all 20 patients enrolled in the trial in the second quarter of 2021,” noted James Sapirstein, the company CEO.AzurRx shares fell

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AzurRx reports clinically meaningful effect in condition linked to cystic fibrosis