AzurRx BioPharma Announces Two Abstracts Accepted for Presentation at the 2020 North American Cystic Fibrosis Virtual Conference

Rhea-AI Summary

AzurRx BioPharma (NASDAQ: AZRX) announced two accepted abstracts for the North American Cystic Fibrosis Conference (NACFC) from October 7 to 23, 2020. These include results from the Phase 2 OPTION clinical trial of non-porcine MS1819 lipase, which showed good tolerance at a daily dose of 2g. Additionally, the company identified an effective enteric capsule for MS1819, enhancing its delivery into the duodenum. The findings aim to position MS1819 as a safer alternative to traditional porcine enzyme therapies for cystic fibrosis patients.

Positive

• Phase 2 OPTION clinical trial results show MS1819 is well-tolerated with no significant safety concerns.
• Effective identification of an enteric capsule for better delivery of the non-porcine MS1819 enzyme.

Negative

• None.

Abstracts to Focus on:

Results from Phase 2, Open-Label, Multicenter, 2x2 Cross-Over Trial to Assess Safety and Efficacy of MS1819 in Patients with Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

&

Best Enteric Capsule for Targeted Duodenal Delivery of Non-Porcine MS1819 Lipase Enzyme

NEW YORK, Sept. 15, 2020 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that two abstracts have been accepted for presentation at the North American Cystic Fibrosis Conference (NACFC) to be held virtually October 7 – October 23, 2020. The abstracts will be showcased in the NACFC virtual poster gallery and electronically published as a supplement to Pediatric Pulmonology.

“We are pleased to present the results from the Phase 2 OPTION clinical trial demonstrating that the non-porcine MS1819 lipase is well-tolerated with no clinically significant safety signals at the 2g daily dose,” said James Sapirstein, President & CEO of AzurRx. “Furthermore, we have evaluated four different enteric capsules and identified the best suitable formulation for MS1819 that provides gastroprotection of enzyme content and delayed release into the duodenum. Our clinical program continues to advance, and we are determined to develop MS1819 as a safer alternative to porcine pancreatic enzyme replacement therapy (PERT), significantly reducing the pill burden of cystic fibrosis patients.”

Presentation Poster Details Below:

Title:	“Results From a Phase 2, Open-Label, Multicenter, 2X2 Cross-Over Trial to Assess the Safety and Efficacy of MS1819 in Patients with Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis”
Poster #:	228
Presenter:	Michael Konstan, MD – Case Western Reserve University
Time:	Available virtually to registered attendees starting on October 7, 2020

Title:	“Evaluation and Selection of An Enteric Capsule for Targeting Duodenal Delivery of Non-Porcine MS1819 Lipase Enzyme”
Poster #:	243
Presenter:	Mathieu Schué, PhD – Head of Laboratory, AzurRx BioPharma, Inc.
Time:	Available virtually to registered attendees starting on October 7, 2020

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a biopharmaceutical company specialized in the research and development of non-systemic biologics for gastrointestinal disorders. The Company is focused on the development of its lead drug candidate, MS1819. AzurRx is currently conducting two Phase 2 clinical trials of MS1819: the OPTION 2 monotherapy trial, and the Combination therapy trial, consisting of MS1819 in conjunction with porcine-derived pancreatic enzyme replacement therapy, the current standard of care. The Company is headquartered in New York, NY, with scientific operations based in Langlade, France and clinical operations in Hayward, California. Additional information on the Company can be found at www.azurrx.com.

Forward-Looking Statements
This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company’s belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company’s control. 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, 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 such as the interim results presented will be indicative of the final results of the trial. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results, including those related to the clinical development of MS1819, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 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.
760 Parkside Avenue, Suite 304
Brooklyn, NY 11226
Phone: (646)-699-7855
info@azurrx.com

Investor Relations contact:

LifeSci Advisors, LLC.
Hans Vitzthum, Managing Director
1 International Place, Suite 1480
Boston, MA 02110
Phone: 617-430-7578
hans@lifesciadvisors.com

FAQ

What were the results of the Phase 2 clinical trial for AZRX's MS1819?

The Phase 2 clinical trial demonstrated that MS1819 was well-tolerated with no significant safety issues at a daily dose of 2g.

When will the findings about MS1819 be presented?

The findings will be presented at the North American Cystic Fibrosis Conference, available to registered attendees starting on October 7, 2020.

What is the significance of the enteric capsule for MS1819?

The enteric capsule enhances the gastroprotection of the enzyme and allows for delayed release into the duodenum, improving treatment efficacy.

What is the focus of AzurRx BioPharma?

AzurRx is focused on developing non-systemic therapies for gastrointestinal diseases, particularly targeting cystic fibrosis.

Is MS1819 a safer alternative to current therapies?

AzurRx aims to establish MS1819 as a safer alternative to porcine pancreatic enzyme replacement therapy, potentially reducing the pill burden for patients.