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Yesterday was a notable day for AzurRx BioPharma (NASDAQ: $AZRX), announcing the first two patients dosed in the Phase 2b OPTION 2 extension study of MS1819 for the treatment of pancreatic exocrine insufficiency in patients with cystic fibrosis. Today the announcement followed that a dosing in the pancreatic insufficiency study has started.

The MS1819 is being evaluated using immediate-release capsules for the treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis. The study aims to determine the optimal doses and capsule types for the potential late stage development of MS1819. Key data from the study is expected in the first quarter of this year. This is followed by an FDA meeting to discuss the study design, AzurRx BioPharma shared today.

The OPTION 2 extension study was initiated, because it was previously requested to change the company’s protocol to the FDA to evaluate immediate-release capsules of the MS1819. Data from a previously completed phase 2 OPTION study has shown meaningful improvements in the coefficient of fat absorption following MS1819 monotherapy treatment.

In addition to the above, AzurRx BioPharma is also evaluating MS1819 in combination with the current standard of care as a possible treatment for cystic fibrosis patients with severe exocrine pancreatic insufficiency. This combination may bring clinical improvements in the fat absorption coefficient and alleviate abdominal symptoms. This is evident from research data presented in 2020 during the Biotech Showcase Conference 2020.

In addition to the studies, the company has also signed a license agreement with First Wave Bio, for the use of proprietary oral and rectal formulations of niclosamide. The aim is to achieve a treatment for colitis from immune checkpoint inhibitors and COVID-19 gastrointestinal infections. A clinical trial is expected before the summer of this year.

Data Monitoring Committee (DMC) continues to support the AzurRx BioPharma program without any safety concerns related to study design and protocol. Remarkably, after the announcement, AZRX shares rose 34.6% yesterday.

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By Omar