On May 23, 2018, we published revised versions of our Privacy Policy and User Agreements. Please read these updated terms and take some time to understand them. Your use of our services is subject to these revised terms.
Yes, I Agree.

AzurRx BioPharma, Inc. (NASDAQ: AZRX) is “One to Watch”

With more than a century of combined experience spanning the gamut from pancreas/GI tract issues in hepato-gastroenterology and infectious disease to the development of novel non-systemic (localized) therapeutic biologics and proteomics (protein engineering), the AzurRx BioPharma, Inc. (NASDAQ: AZRX) core science team is the real strength behind the company’s developing portfolio of recombinant therapies. AzurRx has come quite a long way on the strength of its science-driven approach and today stands tall upon the IP foundation of its two main pipeline programs. The lead candidate of which, MS1819 lipase, is currently in ongoing, open-label Phase IIa trials in EPI (exocrine pancreatic insufficiency) associated with chronic pancreatitis (CP). Human trialing where this novel, orally delivered, non-systemic (non-absorbable, locally-acting, does not reach systemic circulation), yeast-derived recombinant enzyme has already shown solid dose responses at various levels with no apparent safety issues.

Given such positive Phase IIa in vivo study data (reported in mid-April 2017), where the efficacy of MS1819 is characterized by a 20 percent increase in the coefficient of fat absorption in all patients (or CFA, the primary efficacy endpoint), AZRX is confident that its lead candidate will continue to show a marked superiority to currently marketed, porcine-derived pancreatic enzyme replacement therapies (PERTs). With an anticipated completion of the MS1819 Phase IIa in the third-quarter of 2017 and strong applications for the drug in EPI associated with CF (cystic fibrosis), as well as demonstrably apparent efficacy in CP-associated EPI, the $8.50 valuation set by Zacks Small-Cap Research earlier this year (January, April) looks well within striking distance (given that the projection is based on a 2020 launch of MS1819).

A recent report from April of 2017 by GlobalData paints a bullish picture for the broader CF market with a CAGR of around 13.6 percent through 2025 when it will reach upwards of $7.6 billion on the strength of new drugs becoming available. This is exciting news when contrasted with the Transparency Market Research projection from last year, which depicts the EPI space alone to be worth around $2.85 billion by 2023, on a CAGR of some 8.3 percent, with the U.S. representing roughly 57 percent of that global pie. The PERT market is currently dominated by a small handful of players, with the AbbVie (NYSE: ABBV) drug Creon accounting for the lion’s share, and newer, more technologically advanced entrants such as Allergan’s (NYSE: AGN) Ultresa currently being seen by analysts as having the highest future growth rate.

However, these drugs and other PERTs such as Nutrizym, Pancrease and Pancrex are derived from pig pancreas gland extracts, carry a pork viral contamination risk, and thus represent a biopharma niche that is ripe for disruption by an innovator like AZRX.

PERT Demand May be Larger than Expected

Somewhere from 10 to 12 million people in the U.S. are estimated to carry the defective CF gene that leads to CF, and while the patient population is only around 30,000 or more, it can be inferred from CDC statistics that there are approximately 400 or more new cases in the U.S. alone each year (around 1,000 worldwide). CF is also no longer considered a childhood disease like it was only a few decades ago, because patients are now able to more effectively manage the disease via therapy and have an average life expectancy of around 37 years. EPI is observed to occur in 85 to 90 percent of CF patients according to research done by one of the most trusted names in pathology, Robbins Basic Pathology.

With the rate of CP around 50/100,000, and a growing awareness of the influence of diabetes on pancreatic exocrine function, the emergence of a yeast-derived recombinant enzyme therapy such as MS1819 is really something to take note of, especially due to the fact that AZRX’s offering has shown high potency in low pH environments (stable in protease and bile salt environments), and activity in long chain fats. EPI affects as many as half of all the people with insulin-dependent diabetes by some estimates, and it is well-known that CP patients typically develop type 3c diabetes. The key takeaway in all of this is that there is a growing market for MS1819, a drug which is now clearly underscoring the success of earlier Phase Ib in vitro work, during in its ongoing Phase IIa in vivo trial.

Phase IIb Enabling Trial & Successful Placement Very Bullish

CEO of AzurRx BioPharma, Thijs Spoor, was clearly pleased by extant Phase IIa results with MS1819, pointing to the observably robust dose-response pattern and overall safety characteristics. Anticipation is high that MS1819 will prove to be a more effective and safer alternative to existing PERTs. Given the warm reception by patients, as well as physicians noted by the Clinical Investigator, this drug could gobble up market share very quickly.

It’s little wonder then that the recent private placement financing (closing announced June 8) went so well, with the issuance designed to fund the MS1819 program being over-subscribed, allowing AZRX to rake in gross proceeds of some $5 million. The $3.50 priced units in the placement consisted of a share of common stock, one Series A Warrant for 0.25 shares at $4.00 (exercisable through Dec 31, 2017), and one Series A-1 Warrant for 0.75 shares at $5.50 (exercisable six months after closing through June 6, 2022).

Potential Sleeper Hit in the Wings

The second program under development by AZRX at this time is another oral non-systemic, AZX1101 (recombinant beta-lactamase derived from a bacterial source), which is in the preclinical stage for localized shielding of the GI tract against HAIs (hospital-acquired infections) associated with broad-spectrum beta-lactam antibiotic use. Beta-lactam antibiotics (especially penicillins and cephalosporins) have really come into their own as the drugs of choice for many infections, but their use is also frighteningly threatened by the emergence of increasingly resistant strains of bacteria.

This could be a nice one-two punch lineup for AZRX, with MS1819 commercialization supercharging the development ramp for AZX1101, amid a global infection control market that is on-track to run a 6.5 percent CAGR through 2021, reaching around $17.78 billion on the dominance of factors such as the growing prevalence of HAIs. It is worth noting that the Zacks Small-Cap Research doesn’t even factor the potential upside from AZX1101 into its $8.50 price target, despite the admittedly substantial market opportunity.

To take a closer look, visit http://www.azurrx.com

About QualityStocks

QualityStocks is committed to connecting subscribers with companies that have huge potential to succeed in the short and long-term future. It is part of our mission statement to help the investment community discover emerging companies that offer excellent growth potential. We offer several ways for investors to learn more about investing in these companies as well as find and evaluate them.

QualityStocks (QS)
Scottsdale, Arizona
www.QualityStocks.com
480.374.1336 Office
[email protected]

Please see full terms of use and disclaimers on the QualityStocks website applicable to all content provided by QS, wherever published or re-republished: http://www.qualitystocks.net/disclaimer.php

Archives

Select A Month
  • October 2020
  • September 2020
  • August 2020
  • July 2020
  • June 2020
  • May 2020
  • April 2020
  • March 2020
  • February 2020
  • January 2020
  • December 2019
  • November 2019
  • October 2019
  • September 2019
  • August 2019
  • July 2019
  • June 2019
  • May 2019
  • April 2019
  • March 2019
  • February 2019
  • January 2019
  • December 2018
  • November 2018
  • October 2018
  • September 2018
  • August 2018
  • July 2018
  • June 2018
  • May 2018
  • April 2018
  • March 2018
  • February 2018
  • January 2018
  • December 2017
  • November 2017
  • October 2017
  • September 2017
  • August 2017
  • July 2017
  • June 2017
  • May 2017
  • April 2017
  • March 2017
  • February 2017
  • January 2017
  • December 2016
  • November 2016
  • October 2016
  • September 2016
  • August 2016
  • July 2016
  • June 2016
  • May 2016
  • April 2016
  • March 2016
  • February 2016
  • January 2016
  • December 2015
  • November 2015
  • October 2015
  • September 2015
  • August 2015
  • July 2015
  • June 2015
  • May 2015
  • April 2015
  • March 2015
  • February 2015
  • January 2015
  • December 2014
  • November 2014
  • October 2014
  • September 2014
  • August 2014
  • July 2014
  • June 2014
  • May 2014
  • April 2014
  • March 2014
  • February 2014
  • January 2014
  • December 2013
  • November 2013
  • October 2013
  • September 2013
  • August 2013
  • July 2013
  • June 2013
  • May 2013
  • April 2013
  • March 2013
  • February 2013
  • January 2013
  • December 2012
  • November 2012
  • October 2012
  • September 2012
  • August 2012
  • July 2012
  • June 2012
  • May 2012
  • April 2012
  • March 2012
  • February 2012
  • January 2012
  • December 2011
  • November 2011
  • October 2011
  • September 2011
  • August 2011
  • July 2011
  • June 2011
  • May 2011
  • April 2011
  • March 2011
  • February 2011
  • January 2011
  • December 2010
  • November 2010
  • October 2010
  • September 2010
  • August 2010
  • July 2010
  • June 2010
  • May 2010
  • April 2010
  • March 2010
  • February 2010
  • January 2010
  • December 2009
  • November 2009
  • October 2009
  • September 2009
  • August 2009
  • July 2009
  • June 2009
  • May 2009
  • April 2009
  • March 2009
  • February 2009
  • January 2009
  • December 2008
  • November 2008
  • October 2008
  • September 2008
  • August 2008
  • July 2008
  • June 2008
  • May 2008
  • April 2008
  • March 2008
  • February 2008
  • January 2008
  • December 2007
  • November 2007
  • October 2007
  • September 2007
  • August 2007
  • July 2007
  • June 2007
  • May 2007
  • April 2007
  • March 2007
  • February 2007
  • January 2007
  • December 2006
  • November 2006
  • October 2006
  • September 2006
  • August 2006
  • July 2006
  • June 2006
  • May 2006
  • April 2006
  • March 2006
  • January 2006
  • December 2005
  • October 2005
  • September 2005
  • Market Basics

    New to the micro-cap markets?Get answers to your questions about investing in Small-Cap / Micro-Cap Stocks and learn how to protect yourself.

    The Basics

    Newsletter Publishers

    Have an up and coming newsletter and want to be included in our coverage list? Looking to get more coverage and grow subscriptions? Register for coverage.

    Register

    Public Companies

    Are you a Small-Cap / Micro-Cap company looking for coverage? We'd love to hear from you. Fill out our quick contact form or send us a text.

    Get Covered