DELRAY BEACH, Fla., Jan. 08, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ: AZRX), a company specializing in the development of targeted non-systemic, recombinant therapies for gastrointestinal (GI) diseases, today issued the following letter to its shareholders and the investment community from James Sapirstein, President and Chief Executive Officer.
Dear AzurRx Shareholders,
We begin this year with great optimism and welcome 2021 with enthusiasm. Last year is not one anyone will soon forget, and I am proud of our extraordinary accomplishments in the face of so many challenges. This year, already, we are building on the momentum and wasted no time in making an impact with the announcement of a transformative in-licensing agreement with First Wave Bio, bringing in a new asset and two new GI indications into our development fold.
AzurRx – Three GI Clinical Shots on Goal in 2021
AzurRx is a fundamentally stronger company today compared to 12 months ago, from a strategic, operational and financial perspective. We now have three targeted, non-systemic clinical-stage GI assets in our pipeline that address significant unmet clinical needs in potential billion-dollar markets. I believe we are poised to increase shareholder value. The Company recently raised capital in order to pay for the up-front licensing opportunity, without having to impact the budget for our MS1819 clinical timelines. In the long run, AzurRx is much better positioned to provide valuable products with significant market opportunities into the GI space.
MS1819 – On Track for Top-Line Data Readouts in Q1 and Q2
We remain focused on the successful development of our lead MS1819 program for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis. I am happy to report that we remain well on track for meeting our previously-announced clinical milestones. We expect top line data from our Phase 2b OPTION 2 monotherapy trial in Q1 2021 and from our Phase 2 CF combination therapy trial (MS1819 + PERT) in Q2 2021. Given the substantial target market of more than $1.4 billion in the U.S. and over $2 billion globally, we remain optimistic that MS1819 has strong potential to attract partnership opportunities and licensing interest from Big Pharma.
Niclosamide – An Ideal Profile for a GI-Targeted Agent
Micronized niclosamide is a great addition to our portfolio. Niclosamide is an FDA-approved drug in other indications with broad spectrum anti-viral and anti-inflammatory properties that has been safely used by millions of patients. Using a patented and proprietary process, First Wave has developed an ideal formulation of niclosamide that potentially improves on the beneficial properties of this already approved drug while keeping a consistent safety profile.
Immune Checkpoint Inhibitor Colitis – Enabling Oncology Patients to Stay on Treatment
We were attracted to micronized niclosamide not only for its efficacy and safety profile, but also because of the attractive market in checkpoint-inhibitor associated colitis. The global market of immune checkpoint inhibitors (ICIs) is significant; it was over $22 billion in 2019 and growing rapidly. However, use of ICIs, particularly higher dose and combinations of ICIs can be limited by development of potentially life-threatening side effects, such as checkpoint-inhibitor associated colitis. Patients who exhibit these side effects risk interrupting or stopping their cancer therapy. There currently is no approved treatment for grade 1 colitis.
Our new asset, with its targeted non-steroidal properties has the unique potential ability to safely treat grade 1 ICI colitis and diarrhea, and prevent its progression to more serious and potentially fatal later stages. This would enable oncology patients to continue their course of life-saving cancer therapy, or spend minimal time off of, their ICI treatment programs without interruption.
COVID-19 GI Infections – Treating a Significant Unmet Need in the Global Pandemic
Our second new indication, COVID-19 GI infections, is another natural fit for us. A recent study reported that 18% of COVID patients reported GI symptoms and almost 50% of the COVID patients had viral RNA in their stool. To put this in perspective, of the 19 million individuals who are reported to have contracted COVID-19 in the United States, this would translate into 3.4 million patients having reported GI infections. Of the 81 million cases globally, it would be 15 million patients. There currently is no targeted treatment for COVID GI infections.
We believe micronized niclosamide has the potential to destroy COVID in the GI tract by decreasing viral load in the gut, treating infection symptoms, such as diarrhea and abdominal pain, and preventing transmission of the virus through fecal spread. Given niclosamide’s safety profile in other indications, we believe that it can be safely used for both patients who exhibit GI infection symptoms and patients who test positive for the virus. Even with the global roll-out of vaccines in the 2020-2022 timeframe, we believe millions of patients will still be affected and with the emergence of new strains, COVID-19 will continue to be a significant public health issue for several more years.
Initiating Two New Clinical Trials in 1H 2021- Expedited Regulatory Pathway
We anticipate entering into the clinic with two micronized niclosamide clinical programs in the first half of 2021, a Phase 1b/2a clinical trial for the treatment of grade 1 Immune Checkpoint Inhibitor-Associated Colitis (ICI-AC), and an IND-approved Phase 2 trial for COVID-19 GI infections. We believe that both programs can be completed relatively quickly – COVID-GI in approximately 12 months and ICI in approximately 18 months – and that both have the potential for accelerated regulatory pathways, FDA 505(b)(2) and potential breakthrough designation, respectively. This has the potential to both significantly reduce development timelines and costs and bring these novel therapies to late-stage oncology and COVID patients much faster.
Outlook Ahead
With our new expanded pipeline, this year will bring many value building catalysts and events as we advance clinical development of MS1819, initiate new trials for micronized niclosamide in immune checkpoint colitis and COVID-19 GI, and prepare for an anticipated end of Phase 2 meeting with the FDA for MS1819.
We will continue our investor and public relations initiatives, and position the company to attract additional investors and awareness around the globe to provide long-term returns to our shareholders.
We look forward to a productive and meaningful year and thank you for your continued support.
Sincerely,
James Sapirstein
President & CEO
AzurRx BioPharma, Inc.
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 three gut-restricted GI clinical programs. 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, currently in two Phase 2 clinical trials. AzurRx is launching two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor; FW-420, for grade 1 Immune Checkpoint Inhibitor-Associated Colitis and diarrhea in oncology patients and FW-1022, for COVID-19 gastrointestinal infections. The Company is headquartered in Delray Beach, Florida with clinical operations in Hayward, California. For more information visit www.azurrx.com.
