BROOKLYN, N.Y., Dec. 01, 2016 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal (“GI”) diseases, announced today the release of a Company overview as presented by AzurRx's President & CEO, Thijs Spoor.
Mr. Spoor began the communication by stating, "This Company overview serves to provide shareholders with a perspective on AzurRx, its evolution and future potential. Let me begin with the fundamentals. We have a clear, focused plan for value creation, building our pipeline assets with a short-term, lower-risk development pathway, an experienced management team and first-class advisors.
We believe that our focus on non-systemic therapies represents a new frontier for developing therapies. Our pipeline, led by MS1819 and followed by AZX1101, is moving ahead and we have further strengthened and we continue to expand our global patent portfolio. Non-absorbable drugs are a unique subset of orally administered agents that exert their therapeutic effects locally in the GI tract. In contrast to traditional drugs, which are designed to be rapidly absorbed, achieve therapeutic plasma levels, and then be eliminated by multiple pathways, non-absorbable drugs are designed to only act locally in the gut. It is our belief that if drugs are not absorbed into the bloodstream, then it is very difficult for them to reach the liver, heart, brain or other organs, and thus we believe that the chance of having serious side effects is decreased.
We continue to make progress with our lead agent MS1819-SD, a yeast derived recombinant lipase, for the treatment of exocrine pancreatic insufficiency (“EPI”) related to chronic pancreatitis (“CP”) and cystic fibrosis. We previously announced the initiation of the Phase II trial of MS1819 in EPI due to CP. We anticipate active participation from the sites in Australia and New Zealand in this un-blinded dose escalation trial, with initial results anticipated in the first half of 2017. With a potentially superior efficacy profile, we expect MS1819 to provide a true clinical benefit to EPI patients, offering materially improved efficacy and a dramatically reduced pill burden. Commercially, the EPI market, consisting of porcine derived products, was estimated to be approximately $1.5 billion in 2015 and is projected to increase to approximately $2.85 billion by 2023, according to market research firm Transparency Market Research.
Our second development stage agent, AZX1101, is a complex biologic in development for the prevention of nosocomial (hospital acquired) bacterial infections. Discovered in-house at AzurRx’s labs, AZX1101 acts by blocking the activity of a broad range of antibiotics from acting within the GI tract, thereby preventing toxicity of intravenous antibiotics to gut bacteria, and thus maintaining a healthier gut flora balance. We expect to file an Investigational New Drug Application for AZX1101 in 2017. While the potential applications of AZX1101 are broad, we intend to develop this agent for the prevention of clostridium difficile (C. diff) infection. The Centers for Disease Control has estimated that roughly 1.7 million hospital associated infections (i.e. ~5% of the number of hospitalized patients) cause or contribute to 99,000 deaths each year in the U.S., with the annual cost ranging from $4.5 billion to $11 billion.
We have a terrific team of experienced, dedicated professionals at both our French and U.S. locations and intend to continue to strengthen our management and advisory boards with clinical experts in the fields of gastroenterology, cystic fibrosis, and infectious disease.
In summary, with MS1819 and AZX1101, we have a clear, focused plan for value creation, with significant milestones over the next 6-12 months. We also plan to bolster the team’s capabilities as the Company expands into the rapidly evolving infectious disease and microbiome space. Thijs Spoor, CEO of AzurRx, noted; “It is clear that novel therapies are urgently needed for gastro-intestinal and infectious diseases and we are focused on driving forward the development of our pipeline to provide patients around the world with new products that provide true clinical benefit. This is an exciting time for AzurRx as we build towards near-term value inflections.”
About AzurRx BioPharma
AzurRx BioPharma, Inc. (NASDAQ:AZRX) is engaged in the research and development of non-systemic biologics for the treatment of patients with gastrointestinal disorders. MS1819 recombinant lipase for exocrine pancreatic insufficiency is the company’s lead development program, and additional early stage research is being conducted for the prevention of hospital-acquired infections. The company is headquartered in Brooklyn, NY, with scientific operations based in Langlade, France. Additional information on the Company can be found at www.azurrx.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigations Reform Act of 1995. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the development and testing of our drug candidates, the regulatory approval process, our ability to secure additional financing, the protection of our patent and intellectual property, the success of strategic agreements and relationships, and the potential commercialization of any product we may successfully develop. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
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AzurRx BioPharma, Inc.
760 Parkside Avenue,
Brooklyn, NY 11226