AzurRx BioPharma Announces WHO Publication of “Adrulipase Alfa” as International Nonproprietary Name for MS1819
AzurRx BioPharma, Inc. (NASDAQ: AZRX) announced that the World Health Organization has proposed "adrulipase alfa" as the International Nonproprietary Name for MS1819, a recombinant lipase enzyme aimed at treating exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis and chronic pancreatitis. This designation signifies validation in its development process and differentiation from current therapies. The company expects to release full results from its Phase 2 combination therapy trial by Q3 2021, with WHO's final decision on adrulipase alfa expected by November 2021.
- WHO's proposal of adrulipase alfa as the INN for MS1819 validates the drug's development.
- MS1819 offers a non-animal product alternative to existing pancreatic enzyme therapies.
- Expected release of full trial results from the Phase 2 combination therapy study in Q3 2021.
- No significant financial metrics provided in the PR.
- Potential risks highlighted by the forward-looking statements regarding clinical trials outcomes.
BOCA RATON, Fla., Aug. 17, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (“AzurRx” or the “Company”) (NASDAQ: AZRX), a company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced the World Health Organization (WHO) has published “adrulipase alfa” as the proposed International Nonproprietary Name (INN) for MS1819. MS1819 is a recombinant lipase enzyme that is currently under development for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis and chronic pancreatitis.
“The assignment of adrulipase alfa as the proposed International Nonproprietary Name for MS1819 is an important step in the ongoing development of this drug technology,” said James Sapirstein, President and CEO of AzurRx. “Assignment of an INN signifies that a pharmaceutical substance has reached a point in its development where it is now beneficial to specify to pharmacists and medical doctors, via nomenclature, the substances contained in a preparation. For MS1819, we view this as further validation of the technology. It is a clear point of differentiation as we continue the drug’s development as a potential treatment for EPI that could improve upon the current standard of care, porcine-derived pancreatic enzyme replacement therapy (PERT).”
AzurRx is pursuing parallel monotherapy and combination therapy clinical pathways with MS1819. The Company reported topline results from its Phase 2b OPTION 2 monotherapy trial in March 2021 and expects to report full topline results from its Phase 2 combination therapy trial, evaluating MS1819 in combination with PERT, for the treatment of severe EPI in patients with cystic fibrosis, in the third quarter of 2021.
The WHO is expected to render a final decision on the use of adrulipase alfa for MS1819 by November 2021.
About MS1819 (adrulipase alfa)
MS1819 is a recombinant lipase enzyme that has been developed for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis. MS1819, supplied as an oral, non-systemic, biologic capsule, is derived from the Yarrowia lipolytica yeast lipase and breaks up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients. Unlike the standard of care, the MS1819 lipase does not contain any animal products.
About Exocrine Pancreatic Insufficiency
EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in maldigestion. The deficiency in this enzyme can be responsible for greasy diarrhea, fecal urge and weight loss.
There are more than 30,000 patients in the U.S. with EPI caused by cystic fibrosis according to the Cystic Fibrosis Foundation and approximately 90,000 patients in the U.S with EPI caused by chronic pancreatitis according to the National Pancreas Foundation. Patients are currently treated with porcine pancreatic enzyme replacement pills.
About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of two gut-restricted GI assets in three clinical indications. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis. AzurRx is also advancing two clinical programs using proprietary formulations of niclosamide, a small molecule with anti-viral and anti-inflammatory properties: FW-1022, for COVID-19 gastrointestinal infections and FW-420, for Grade 1 and Grade 2 Immune Checkpoint Inhibitor-associated colitis and diarrhea in advanced oncology patients. The Company is headquartered in Boca Raton, Florida with clinical operations in Hayward, California. For more information visit www.azurrx.com.
Forward-Looking Statement
This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; the size of the potential markets for the Company’s drug candidates and its ability to service those markets; and the Company’s current and future capital requirements and its ability to raise additional funds to satisfy its capital needs. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.
For more information:
AzurRx BioPharma, Inc.
777 Yamato Road, Suite 502
Boca Raton, FL 33431
Phone: (561) 589-7020
info@azurrx.com
Media contact:
Tiberend Strategic Advisors, Inc.
Johanna Bennett / David Schemelia
(212) 375-2665 / (609) 468-9325
jbennett@tiberend.com / dschemelia@tiberend.com
FAQ
What is the significance of the WHO naming adrulipase alfa for AZRX's MS1819?
When will AZRX report the full results of the MS1819 clinical trials?
How does MS1819 differ from current treatments for EPI?
What are the expected outcomes from the WHO regarding adrulipase alfa?
