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AzurRx BioPharma Inc. (NASDAQ: AZRX) is a clinical-stage biopharmaceutical company focused on developing treatments for gastrointestinal diseases using recombinant proteins.
The company’s lead drug candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients suffering from cystic fibrosis and chronic pancreatitis.
AzurRx has already completed two Phase 2 clinical trials for MS1819 and is currently pursuing approval through parallel monotherapy and combination therapy pathways.
The company was founded in 2014 and is headquartered in New York City, with scientific operations in Langlade, France, and clinical operations in Hayward, California.
Investment Considerations:
- AzurRx BioPharma’s lead therapeutic, MS1819, is a recombinant lipase treatment for exocrine pancreatic insufficiency and is currently targeting patients with cystic fibrosis and chronic pancreatitis – an established global market of more than $2 billion.
- The company is currently pursuing parallel monotherapy and combination therapy trials, which are anticipated to produce topline data in Q1 2021 and Q2 2021, respectively.
- Previously completed clinical trials of MS1819 showed primary and secondary endpoint efficacy, with a positive safety profile.
- To fully finance its ongoing Phase 2 trials and being preparations for a pivotal Phase 3 study in 2021, as well as to fund current operations, the company raised gross cash capital of $22.1 million as of July 2020.
- AzurRx is determined to develop MS1819 as a safer alternative to porcine pancreatic enzyme replacement therapy, significantly reducing the pill burden of cystic fibrosis patients.
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