James Sapirstein, Chairman, President and CEO,

FIRST WAVE BIOPHARMA

"I believe that in the near future we will be able to effectively control the Covid-19 virus with therapeutics."

How did First Wave BioPharma (First Wave) perform over the past year?

During the pandemic AzurRx BioPharma decided to acquire First Wave Bio, and the merged company was renamed First Wave BioPharma. Through the transaction and merger, we purchased full rights to First Wave’s proprietary formulations of niclosamide and exclusive international rights to develop oral and topical formulations of the compound for all gastrointestinal indications (GI), including Covid-related GI infections; IBD indications including ulcerative colitis (UC) and Crohn’s disease; and immune checkpoint inhibitor-associated colitis and diarrhea. We own the method of usage and delivery of these formulations as therapies for several auto-immune, inflammatory and viral ailments.

In 2021 we started enrolling patients into our FW-COV trial, involving the delivery of a proprietary oral tablet formulation of micronized niclosamide for the treatment of Covid-19 related GI infections. We believe that vaccines are not the answer to resolving Covid and that therapeutics are necessary to help us get on the other side of the pandemic. Through our trials, we hope to demonstrate the safety of niclosamide in the treatment of patients with Covid-19 GI infection and to prove efficacy in clearing the virus from the GI tract. We have also started advancing our FW-UP study, a niclosamide-based, topical anti-inflammatory inhibitor therapy for the treatment of ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS), two forms of ulcerative colitis.

What can niclosamide do which vaccines cannot?

Current Covid-19 vaccines work on the spike proteins, which is where the viral mutations, such as Omicron, occur. Our niclosamide formulations are spike-agnostic; they work in the virus membrane and are not dictated by mutations that might happen. Our drug explodes the membrane of the virus so that it cannot replicate. The Covid-19 virus also causes inflammation and niclosamide has anti-inflammatory properties that has been safely used on millions of patients worldwide. I believe that in the near future we will be able to effectively control the Covid virus with therapeutics.

How far progressed is First Wave’s FW-COV study?

We completed enrollment in the FW-COV study with over 167 patients on 4 January 2022 and are in the process of tabulating the final data. We know that niclosamide does not have an antiviral effect on Covid-19. Unfortunately, the results did not demonstrate efficacy from the virology front, but we are still working through the data to determine it’s effect in the GI system. The trial did produce strong safety results which can be utilized in the future development program.

Can you elaborate on First Wave’s second proprietary technology, adrulipase?

Adrulipase is a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients. First Wave conducted two studies addressing Exocrine Pancreatic Insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis, with one study delivering mixed results and the other extremely good results. The patients in our combination study, where we added adrulipase to existing therapy, did really well. In our mono-therapy trial, where we compared ourselves to other PERTs on the market, our drug had great effects in some patients but no effect in others. We immediately started working on a new formulation and are at the end stage of completing laboratory testing and moving on to human patients again. If we can accomplish uniform absorption in humans with the new formulation in the next Phase 2 study, which we anticipate will initiate in the second half of 2022, we can move to a pivotal Phase 3 trial.

How aggressive is the Intellectual Property (IP) landscape in the U.S.?

US companies usually have a narrow window to monetize a product under patent. Patents generally last for 20 years from the moment you file for IP, but it typically takes a company 8-12 years to develop a drug and bring it to market. Generic companies will start producing formulations often before the patent expires to be ready to hit the marketplace as soon as the patent restrictions are lifted. First Wave is fortunate to have very strong formulation, method of use, and indication patents for both niclosamide and adrulipase, and our key IP is secure for 15-20 years.

What are First Wave’s objectives for the next two years?

We will continue advancing our pipeline to become a fully developed GI company and hope to get both adrulipase and niclosamide to the market as soon as possible.