• Globally it is estimated that 70,000 people suffer from CF, with half the population in the United States
• The global CF therapeutics market size was valued at $4.62 billion in 2018 and is expected to reach an estimated $9.3 billion by 2026
• AzurRx BioPharma’s MS1819, currently undergoing clinical trials, is a promising therapy for severe exocrine pancreatic insufficiency in patients with cystic fibrosis

While still a relatively rare genetic disease, cystic fibrosis (“CF”) remains a dangerous condition that affects multiple body functions and organs, putting patients at risk of developing severe life-threatening illnesses. This is why the need for innovative and effective therapies for the treatment of CF-associated ailments, such as AzurRx BioPharma’s (NASDAQ: AZRX) drug candidate for exocrine pancreatic insufficiency, is constantly growing.

According to Allied Market Research, the demand for effective treatment options is driving a global expansion of the CF therapeutics market. Further driven by the availability of personalized drug therapy and molecular prosthetics, the global CF therapeutics market is expected to reach $9.3 billion by 2026, from $4.62 billion in 2018 (https://ibn.fm/E8kIz).

Cystic fibrosis is a progressive, genetic disease characterized by persistent lung infections and limited breathing ability over time as well as significant digestive problems. It is caused by a mutation of the cystic fibrosis transmembrane conductance regulator (“CFTR”) gene making it unable to transport salts across cell membranes, resulting in the buildup of thick and sticky mucus in different organs and tissues.

In the lungs, the mucus clogs the airways and traps germs, which leads to infections, respiratory failure, inflammation, and other complications. The pancreas is also affected by the buildup of mucus, which prevents the release of digestive enzymes. These digestive enzymes are key to absorbing food and nutrients, often leading to malnutrition and poor growth (https://ibn.fm/ucQP4). Many patients with CF have a weak immune system and are also at a higher risk of developing other severe health conditions, such as hypersplenism, diabetes, cirrhosis, osteoporosis and arthritis.

Globally, it is estimated that 70,000 people suffer from cystic fibrosis, but the incidence of the disease varies significantly across the globe, as prenatal and newborn screening for CF is not standard practice. The U.S. has one of the highest incidence rates with about 35,000 diagnosed cases, according to the

Centers for Disease Control (https://ibn.fm/YBzVq). A World Health Organization report indicates that the incidence of CF in the U.S. is one in every 3,500 births and slightly higher in the European Union, where one in 2,000-3,000 newborns are affected (https://ibn.fm/DEFzu).

While the condition is largely underdiagnosed in Africa and Asia, a recent study out of India showed that the prevalence of cystic fibrosis could be higher than previously believed. Research conducted by Sir Ganga Ram hospital in Rajendra Nagar, Delhi, and published in the BMC Medical Genetics of London, indicated that one in 2,000 newborns in the populous Asian nation may be at risk of being born with CF, after finding a high carrier frequency of 4.5% in male and female subjects (https://ibn.fm/fCIZ4).

AzurRx’s MS1819 Showing Promising Results

Technological advances have greatly increased the lifespan for those suffering from CF, especially since the 1950s when children with CF rarely made it to elementary school age (https://ibn.fm/5m5XR). The median age of survival for a CF patient is now around 47 years, with many patients living into their 60s (https://ibn.fm/66lO7).

Due to the efforts of companies such as AzurRx BioPharma, the lifespan and quality of life of CF patients could be further improved. AzurRx’s lead product is MS1819, a recombinant lipase that could potentially change the treatment of exocrine pancreatic insufficiency (“EPI”) in CF and chronic pancreatitis (“CP”) patients.

The company is currently undergoing Phase 2 trials and pursuing approval through parallel monotherapy and combination therapy pathways. The two current clinical trials for MS1819 in CF patients are a Phase 2b Option 2 monotherapy trial and a Phase 2 combination therapy trial, using MS1819 together with porcine pancreatic enzyme replacement therapy (“PERT”), the current standard of care. Preliminary results from the combination trial have shown clinically meaningful improvements in subjects, with no adverse safety events.

The company believes that due to its safety and efficacy, MS1819 has the potential to improve the quality of life and help achieve healthier nutrition for many patients suffering from severe EPI. AzurRx is scheduled to complete treatment of all patients and announce top line data from both clinical studies in 2021.

For additional information, visit www.AzurRx.com or contact the following:
AzurRx BioPharma, Inc.
Martin Krusin
Vice President for Corporate Development
Phone: (646) 699-7855
[email protected]

NOTE TO INVESTORS: The latest news and updates relating to AZRX are available in the company’s newsroom at https://ibn.fm/AZRX

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