12/03/2019 11:45:00

AzurRx BioPharma Announces Poster Presentation at the Americas Hepato-Pancreato-Biliary Association 2019 Annual Meeting

NEW YORK, March 12, 2019 (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 a poster presentation at the 2019 Annual Meeting of the Americas Hepato-Pancreato-Biliary Association being held in Miami, Florida on March 20-24, 2019. The poster will focus on data from its Phase II study of MS1819-SD in patients with chronic pancreatitis that was completed in 2018.

“We are pleased to present our positive Phase II data, where we observed both clinical activity and a clear dose response,” said Thijs Spoor, President and CEO of AzurRx. “Our oral MS1819-SD therapy is a novel treatment for patients with gastrointestinal disorders and, based on these encouraging and positive data, we are continuing to progress our clinical trials.  We are currently enrolling patients in our cystic fibrosis study, which has 10 U.S. sites initiated to date with the rest expected to be up and running in the next four weeks. We are excited about the promise of our therapy and look forward to additional data read-outs.”

Poster presentation details:

Title:Reporting a Phase II, open-label study assessing the safety and efficacy of MS1819-SD, a recombinant lipase, for the treatment of exocrine pancreatic insufficiency
Session:Poster Display, Kiosk #8
Date/Time:Friday, March 22, 2019 & Saturday, March 23, 2019
Location:Loews Hotel, Miami Beach, Florida

About the Phase 2 MS1819-SD in Chronic Pancreatitis

The Company previously reported the completion of this open-label, multi-center, dose escalation Phase IIa study, whose primary endpoint was to evaluate the safety of escalating doses of MS1819-SD in patients with chronic pancreatitis. The secondary endpoint for the study was to investigate the efficacy of MS1819-SD in these patients by analysis of the CFA and its change from baseline.  The Company enrolled 11 chronic pancreatitis patients in France, Australia and New Zealand. During the course of the trial, patients “washed-out” of their standard of care treatment for EPI to establish a baseline and then were subsequently treated with escalating doses of study drug in two-week increments.

Final data from the Phase IIa study show a favorable safety profile with no severe adverse events. Although the study was not powered for efficacy, in a pre-planned analysis, the highest dose cohort of MS1819-SD showed statistically significant and clinically meaningful increases in CFA compared to baseline with a mean increase of 21.8% and a p value of p=0.002 on a per protocol basis.

About the Phase 2 MS1819-SD in Cystic Fibrosis

The Company announced that it has dosed the first patients in the Company's Phase II OPTION study to investigate MS1819-SD in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI).

The Phase II, open-label, multi-center, 2x2 crossover study is designed to investigate the safety, tolerability and efficacy of MS1819-SD in a head-to-head comparison against the current porcine enzyme replacement therapy (PERT) standard of care. The primary efficacy endpoint will be a comparison of CFAs after each of the two crossover periods.  Planned enrollment is expected to include approximately 30 CF patients, with the enrollment completed in mid-2019.

Additional information  about the ongoing OPTION MS1819-SD can be found at https://clinicaltrials.gov/ct2/show/NCT03746483?term=ms1819&rank=2 

About Exocrine Pancreatic Insufficiency:

EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in the inability to digest food properly, or maldigestion. This deficiency can be responsible for greasy diarrhea, fecal urge and weight loss.

There are approximately 90,000 patients in the U.S. with EPI caused by chronic pancreatitis according to the National Pancreas Foundation and more than 30,000 patients with EPI caused by cystic fibrosis according to the Cystic Fibrosis Foundation. Patients are currently treated with porcine pancreatic enzyme replacement pills.

About AzurRx BioPharma, Inc.

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-SD recombinant lipase for EPI 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

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. 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-SD and final results of the Phase 2 study, are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 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 

250 West 55th Street - Suite 16B 

New York, NY 10019 

Phone: 617-535-7743 

www.lifesciadvisors.com

hans@lifesciadvisors.com

AzurRx_Logo_CMYK.jpg

Del

Post comment

Related debate

  • 1 week
  • 1 month
  • 1 Year
15 May
DANSKE
Meget interessant refleksion skrevet af Maui. Det kan vores medier godt lære lidt af. Det der kommer..
25
15 May
PNDORA
I gaar aftes sad jeg og kiggede lidt naermere paa guidance fra Pandora for FY2019, som de meldte ud ..
22
21 May
VELO
Så er der lidt at læse på. . Se bla.. Purpose: Tacrolimus extended release (TacER) (Envarsus XR®) ha..
19
17 May
VELO
Hej Alle,   Har siddet og kigget på regnskabet, for at finde ud af hvordan 2019 ender. Umiddelbart e..
18
20 May
PNDORA
Paa trods af et godkendt Q1 regnskab, er aktien faldet som en sten. Markedet er ligeglad med Pandora..
17
18 May
VWS
Ditlev.. Havde store ambitioner, og store armbevægelser .. Ikke alt gik godt.. Men finanskrisen kan..
17
15 May
DANSKE
Apropos skribent 6212.. Og Danske Bank..Ja så må man lade vedkommende at han/hun fik ret. Han anbefa..
16
20 May
DANSKE
Hører på Radio247 at Jyske Bank er indblandet i momssvindel via et par kunder. Penge ud og ind på en..
15
18 May
ZEAL
Nedenfor er det samlet udskift af Q1 telefonkonferencen for Zealand Pharma.    Jeg har først trukket..
15
18 May
AMBU-B
Cook Medical er en førende amerikansk medicovirksomhed med en omsætning på ca. 2 mia. usd og aktivit..
14

#

EuroInvestor: In Focus
#

#

EuroInvestor: In Focus
#

#

EuroInvestor: In Focus
#

Most read news

  • 24 hours
  • 48 hours
  • 1 week
1
Motif Bio to Present Iclaprim Data at ASM Microbe 2019
2
Start of Day Message
3
American Shipping Company ASA - Key information relating to the cash dividend to be paid by AMSC
4
F-Secure Corporation - Managers' Transactions
5
HP and Smile Direct Club Collaborate on Largest Multi Jet Fusion 3D Production Factory in the U.S.

Latest news


Copyright Berlingske Media 2019  Cookie- and Privacy policy  |  Cookies  |   General terms of trade  |   Terms of use and IP rights
Quote information is delivered by Morningstar.
Data is delayed 15-20 minutes according to the distribution agreements set by the different exchanges.
 
22 May 2019 02:36:40
(UTC+00:00) Dublin, Edinburgh, Lisbon, London
Version: LiveBranchBuild_20190514.2 - EUROWEB5 - 2019-05-22 03:36:40 - 2019-05-22 02:36:40 - 1000 - Website: OKAY