Shares of AzurRX BioPharma (NASDAQ: AZRX) have surged premarket after the company reported positive topline results from its Phase 2 Combination Trial evaluating MS1819.
The trial evaluated MS1819 in combination with the current standard of care, porcine-derived pancreatic enzyme replacement therapy (PERT), to treat severe exocrine pancreatic insufficiency in patients with cystic fibrosis.
The company collected data from 20 patients and showed MS1819 in combination with PERT “led to clinically meaningful improvements in the primary efficacy endpoint, the Coefficient of Fat Absorption.”
AzurRx is now developing a new enteric-coated microbead formulation for MS1819 and plans to start a bridging study in 2022 evaluating the formulation as a single-agent therapy.
“This is a positive day for AzurRx, and with data from all 20 study participants in hand, our enthusiasm for the MS1819 program remains undiminished,” stated James Sapirstein, President and CEO of AzurRx.
“Topline data clearly show that combining MS1819 to the daily dose of PERT had clinical benefits for all patients and improved quality of life. Our next step with the MS1819 program is to finalize development of a new enteric-coated microbead formulation, which we believe will enable more of the medication to reach the small intestine thereby enhancing its therapeutic potential. Formulation work is expected to be completed prior to year-end,” added Sapirstein.
The company's shares have rallied 49.49% premarket to $0.7881 following Tuesday's 5% loss.
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