"We are betting that the gastrointestinal tract is where the virus hides, and niclosamide could eradicate COVID-19 from the GI tract."

James Sapirstein

PRESIDENT & CEO, AZURRX BIOPHARMA

March 24, 2021

What are the biggest differences between the AzurRx of 2020 and that of 2021?

AzurRx has gone through a major transformation over the past year. This was driven by our ability to raise a substantial amount of capital in 2020 and into 2021. We also brought in a new clinical-stage asset through an exclusive worldwide license agreement with First Wave Bio. The asset is a micronized version of niclosamide that we are developing as a treatment for two indications - Checkpoint Inhibitor Colitis and COVID-19 GI infections. We expect to initiate clinical trials for both indications in the first half of 2021. In addition, AzurRx continues to advance its clinical program for our lead investigative candidate, MS1819 in cystic fibrosis. We expect to report topline data from the OPTION 2 monotherapy study at the end of Q1. Finally, the combination therapy trial for MS1819 continues and we fully expect to hit our topline data timeline of Q2 2021.

What is the potential for MS1819 to replace PERT as the standard of care for exocrine pancreatic insufficiency (EPI)?

When I first started my career with Eli Lilly, we had a product derived from the recombinant DNA of E. coli called Humulin. The intent was to replace 85 years of porcine-derived insulin in diabetic patients. It took Lilly a few years, but human insulin eventually became the standard of care. We see our MS1819 yeast-derived recombinant lipase as analogous. Why? Because MS1819 is more humanized, it does not have the same antigenicity issue as a porcine-derived product. The production process will be safer, standardized and more consistent. We are not depending on pig herds that sometimes get slaughtered because of swine flu or for some other reason. More importantly, MS1819 requires the ingestion of fewer capsules each day. The reason patients need to take so many capsules with PERT is that they are taking a product made of crushed pig pancreas and you are not really sure how much enzyme they are receiving so you must overcompensate by administering a large number of capsules.

What made the AzurRx-First Wave Bio in-licensing agreement an appealing deal?

Our primary interest in niclosamide was as a treatment for Immune Checkpoint Inhibitor Colitis. But data  from the Institute of Pasteur in Korea indicated that in COVID-19, niclosamide had the best activity in terms of eradicating the virus. The other appealing aspect was Gary Glick, the founder of First Wave Bio. Gary is a gifted chemist and has been prolific in the oncology space. He has had major exits with Novartis, BMS and Merck, so when Gary approached me about looking at niclosamide, we were immediately interested.

What is exciting about niclosamide is the unmet need. Studies demonstrate that 48% of all COVID-19  patients have positive virus RNA in their stool samples. Therefore, this means that almost one-half of COVID patients still have viral RNA in their GI tracts, despite being considered ‘cured’ of the disease. We also know that approximately 20% of all COVID-19 patients have disease-related GI infections, so whether you are vaccinated or not, you are still at risk for getting COVID in the future. We believe niclosamide could be a first-line therapy for this virus. As with HIV, we are going to have to drug our way out of this pandemic.  The available vaccines and those in development are tremendously beneficial, but certainly not a cure-all. We are betting that the gastrointestinal tract is where the virus hides, and niclosamide could eradicate COVID-19 from the GI tract.

What does the improved financial position of AzurRx mean for the progression of MS1819?

One issue facing MS1819 has been manufacturing. Before my arrival, AzurRx did not spend a great deal of capital on manufacturing, but rather the company was  financing to the next clinical endpoint. We are investing capital to augment our manufacturing. The Phase 2b trials are underway and we anticipate having an end of Phase 2 meeting with the FDA towards the end of 2021. At that point, we hope to be able bring in a  strategic partner to get us through Phase 3.

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