Live Wire Reporter

AzurRx BioPharma, Inc. (NASDAQ: AZRX) is in focus after showing that its treatment pipeline has enormous potential to treat not only common GI tract infections but also COVID-19 related infections. That includes the Delta variant, which is causing a manic sense of urgency to get better and long-term treatment solutions to market. The more excellent news for AZRX, and its investors, is its treatments may be closer than most toward earning regulatory approval. And after raising $3 million last week, AZRX is better positioned to accelerate its mission.  

Front and center, AZRX is one of the few clinical-stage companies focused on treating the long-term effects of the COVID-19 virus, specifically in the GI tract, where it can remain for weeks, perhaps even months. Its Phase 2 RESERVOIR trial, examining FW-1022, an oral micronized niclosamide tablet for COVID-19-related GI infections, targets those conditions. If successful, the result could lead to marketing one of the most needed drugs in a generation and be a lifesaver to millions of patients worldwide.  

And more than targeting a critical and unmet medical need, its treatment candidate also sets up a compelling investment proposition for investors that want exposure to a company targeting treatments for COVID-19 as well as its long-term effects on the GI tract. Even better, AZRX can add value well beyond the COVID applications. In fact, they published data making them a clear leader in the race to treat GI-related infection, both COVID and non-COVID-related. Thus, AZRX stock could be in play.

And for good reasons. 

Video Link: https://www.youtube.com/embed/njnE-JljY3Q

Targeting A Niche COVID-Related GI Infection Market 

Those following the headlines know that the Delta variant of the virus infects people across the globe at an alarming rate. Recently, German Chancellor Angela Merkel has warned that Europe is on “thin ice” as the Delta variant of Covid spreads on the continent. And that same worry is rampant in India, Africa, and the United States as well. Actually, it’s a mounting global concern.

Moreover, while vaccine proponents say that current therapeutics may effectively treat COVID-19 and its variants, they have yet to bring the needed attention to the long-term residual effects that the virus can have on the GI tract. There, AZRX believes that the longer-term consequences can have substantial debilitating effects even after overcoming the virus. Thus, despite the encouraging headlines on the preventative front, the story getting less attention is that millions of patients worldwide are now suffering from post-COVID complications. And data indicates that millions of more patients will get added to that list.

Here’s the issue. While not widely reported, the after-effects of COVID-19 can be as harmful as the disease itself. In fact, AZRX is already showing that people who had the virus are experiencing “long haul” GI complications due to what they believe is the ability of the SARS-CoV-2 virus to hide in reservoirs within the GI tract. The resulting conditions are debilitating, with gastrointestinal infection symptoms causing severe diarrhea, vomiting, and abdominal pain. Already, clinical data points toward more than 18% of COVID-19 cases reporting gastrointestinal infections conditions. Worse, these studies indicate that viral RNA-positive stool samples are being reported in approximately 48% of all COVID-19 patients. 

And things don’t get better after that. Data supports that approximately 10% of patients infected with COVID have persistent symptoms months after their initial diagnosis and that over 60% of the long-haul/post-COVID patients have GI infection symptoms. Therefore, while COVID-19 and its variants may be quieted, expect their effects to remain for the long term. And that expectation has caused many in the health community to refer to COVID-19 as endemic. If that’s the case, AZRX is studying the right drugs at the right time. 

And beyond meeting a substantial and unmet need, they could be the first to develop therapeutics to help the world’s population deal with the lasting effects of COVID-19 infections. The excellent news there is that AZRX could be well on its way to doing just that, with therapy candidates showing potentially best-in-class therapeutic value.

Niclosamide Therapeutics Could Be The Answer

Already, AZRX’s niclosamide therapeutic distinguishes itself as a leading candidate to effectively treat many GI-related conditions. However, investors are right to focus on its COVID application, with a growing body of evidence supporting the potential of niclosamide as a COVID-19 therapy. The Institut Pasteur Korea is also bullish on its prospects, noting the drug is a potent inhibitor of SARS-CoV-2, the virus causing COVID-19. Better still, they note potency 40X greater than standard-of-care remdesivir. In addition, a more recent study published in the journal Nature found that niclosamide could prevent long-term lung damage in COVID-19 patients. Those reports inherently show that AZRX is indeed on the right clinical track. 

Still, while independent research supports the drug’s applications, AZRX has generated its own promising data as well. And their data suggest that its micronized oral niclosamide therapy can target SARS-CoV-2 directly in the gut, making it a potentially essential therapeutic for those who contract COVID-19. Notably, with no targeted treatment for COVID-related GI infections, AZRX is looking to deliver the first-to-market therapy targeting this indication.

Better yet, with topline data from its Phase2 RESERVOIR trial expected during the first quarter of 2022, outside funding could come sooner rather than later. Further, positive results could also help earn fast-track designations from agencies scrambling to develop an effective and lasting treatment against the virus. Thus, the next few weeks could be potentially transformative for the company.

Still, while investors are right to focus on the near-term COVID applications, they would be remiss to neglect the inherent value in its developing pipeline. Data there already supports a much higher valuation than current share prices offer.

A Portfolio In Targeting GI tract Infections

And with AzurRx developing a broad pipeline of targeted, non-systemic large and small molecule therapies to treat gastrointestinal (GI) and infectious diseases, value can come sooner rather than later. Better still, those markets add billions more to its value proposition. Even better, AZRX designs its trials to take advantage of lower-risk development pathways and is currently advancing two assets targeting three indications. That design saves money and expands treatment opportunities. It also sets the back half of this year up for multiple potential catalysts.

One may be close at hand, with AZRX expected to release interim results from its Phase 2 combination treatment targeting severe exocrine pancreatic insufficiency in Cystic Fibrosis. That update is expected this quarter. 

Also, its transformative in-licensing deal with First Wave Bio added a new asset and proprietary formulations of micronized niclosamide that could bring tremendous value in the coming quarters. That program adds two new therapeutic indications- treatment for COVID-19 GI infections and immune checkpoint inhibitor-associated colitis (ICI-AC) to its clinical-stage pipeline.

Investors could further benefit from hearing more about the already reported positive topline data from its Phase 2 combination therapy trial using MS1819 combined with the current standard of care, pancreatic enzyme replacement therapy (PERT). Data to date suggests that MS1819 could supplant PERT as the gold standard treatment for EPI in patients with CF and chronic pancreatitis (CP). That drug targets another billion-dollar treatment market. 

Thus, the back half of 2021 is set for a surge in value. And with multiple updates expected, current prices hardly reflect forward-looking potential. In fact, data from its most advanced clinical asset, MS1819, could be worth more than its entire market cap already.

Expect A Surge In 2H 2021

Undoubtedly, AZRX is heading into the back half of 2021 with momentum at its back. They posted positive Phase 2 MS1819 trial data, showed a unique ability to target COVID-related GI infection, and have at least two assets that could be highly attractive to partnership and licensing agreements. Better still, they just closed a capital raise to expedite its initiatives.

Moreover, they have a series of potential catalysts already lined up, with the first likely to come this quarter with topline data from its Phase 2 MS1819 trial imminent. Even better, they are well-positioned to advance multiple shots on revenue-generating goals and target conditions where there are high unmet medical needs. Perhaps best of all, positive Phase 2 trial results could set its drug on the regulatory path to becoming a first-to-market, best-in-class therapy.

Thus, its roughly $44 million market cap today looks substantially light. In fact, with AZRX being a single press release away from a potentially transformative event, that may indeed be the case.

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