Azurrx Biopharma Inc. (NASDAQ: AZRX) stock falls by 3.35% in the current market trading session. AzurRx BioPharma is a medical pharmaceutical business focused on developing non-systemic, tailored treatments for gastrointestinal (GI) disorders.
AZRX stock’ Significant Development
AzurRx BioPharma confirmed recently that the Phase 2 Combination Trial assessing MS1819 in conjunction with the standard treatment, porcine-derived pancreatic enzyme replacement therapy (PERT), for the management of pain exocrine pancreatic insufficiency in cystic fibrosis patients showed positive topline results.
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MS1819 in conjunction with PERT resulted in clinically substantial improvements in the key effectiveness objective, the Coefficient of Fat Absorption, according to data gathered from 20 patients. In comparison to the five-point increase in CFA described in the clinical literature as clinically meaningful, patients demonstrated an average gain of more than six percentage points from baseline. In addition, the study found that weight growth and other secondary endpoints improved.
AzurRx is now working on a novel enteric-coated microbead formulation for MS1819, with a bridging trial assessing the formulation as a single-agent treatment set to begin in 2022. AzurRx’s MS1819 program aims to provide a safe and effective treatment for EPI, a severe gastrointestinal disease common in cystic fibrosis patients that can lead to a variety of life-threatening consequences, including malnutrition. PERT alone refuses to offer enough nutrition to around 25% to 30% of refractory cystic fibrosis patients with severe EPI.
James Sapirstein, President and CEO of AzurRx stated,
This is a great day for AzurRx, and now that they have data from all 20 research participants, their passion for the MS1819 program is even stronger. Topline statistics clearly demonstrate that adding MS1819 to the daily dosage of PERT improved clinical outcomes and quality of life for all patients. The MS1819 project’s next step is to complete the production of a novel enteric-coated microbead formulation, which they hope will allow more of the medicine to reach the small intestine, increasing its therapeutic potential. Work on the formulation should be finished before the end of the year.