AzurRx BioPharma Secures $2 Million Financing to Advance Recombinant Lipase MS1819 as a Non-Animal Alternative to Porcine Pancreatic Enzymes

Recently, VCBeat (WeChat Official Account: vcbeat) learned that New York-based biopharmaceutical company AzurRx BioPharma (NASDAQ: AZRX) announced the completion of a new $2 million financing round. AzurRx BioPharma raised this capital by issuing convertible bonds to its largest shareholder at $2.50 per share. The funds will support the company’s continued research and development of recombinant proteins for the treatment of gastrointestinal disorders and microbiome-related conditions.

AzurRx BioPharma, headquartered in New York with a research facility in Lannemezan, France, is a clinical-stage biopharmaceutical company that went public in 2016 at an IPO price of $5.50 per share. The company primarily develops recombinant enzymes for the treatment of gastrointestinal disorders and conditions related to the gut microbiome. It currently has two product candidates: MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis and chronic pancreatitis; and AZX1101, a recombinant enzyme for the prevention of hospital-acquired Clostridium difficile infection (CDI).

Clostridioides difficile Infection (CDI) is one of the most common causes of healthcare-associated infections and mortality. In the United States, approximately 29,000 patients die from CDI each year. Generally, CDI cases respond well to various oral antibiotics, including vancomycin and metronidazole; however, antibiotic use disrupts the normal gut microbiota, leading to dysbiosis of the microbial microenvironment and ultimately resulting in recurrent CDI.

AzurRx BioPharma employs non-antibiotic approaches to treat and prevent Clostridioides difficile infection (CDI). The company is dedicated to the development of AZ1101, a combination enzyme therapy that effectively reduces CDI recurrence rates and demonstrates favorable tolerability and safety profiles. Currently, AZ1101 remains in the early stages of research and development.

Another product from AzurRx BioPharma, MS1819, is a recombinant lipase for the treatment of pancreatic exocrine insufficiency (PEI) in patients with cystic fibrosis and chronic pancreatitis. Pancreatic exocrine insufficiency (PEI) refers to a condition characterized by inadequate or asynchronous secretion of endogenous pancreatic enzymes due to various causes, leading to impaired nutrient digestion and absorption.

According to data from the National Pancreas Foundation, there are approximately 90,000 patients in the United States with pancreatic exocrine insufficiency caused by chronic pancreatitis, and more than 30,000 patients with pancreatic exocrine insufficiency caused by cystic fibrosis. These patients are currently being treated with porcine pancreatic enzyme replacement tablets.

Compared with the current mainstream drug, porcine pancreatic enzymes, MS1819 demonstrates significant advantages. MS1819 is a lipase produced by yeast, which can be manufactured on an industrial scale, whereas porcine pancreatic enzymes rely on livestock farming, resulting in an unstable supply chain. The major drawback of animal-derived products is their susceptibility to viral contamination, which poses a risk of viral infection to patients; yeast-derived products do not carry this risk.

Currently, AzurRx BioPharma is conducting a Phase IIa clinical trial of MS1819, with trial data expected to be released in mid-2019. The successful development of MS1819 would represent a major innovative breakthrough in the treatment of exocrine pancreatic insufficiency (EPI).

(Compiled by: Tan Xin)