AzurRx Biopharma Acquires First Wave Bio

AzurRx will own full rights to First Wave Bios unique formulations of niclosamide, a small molecule medication with antiviral and anti-inflammatory effects that is targeted to treat a variety of GI diseases, under the terms of the definitive agreement.

FREMONT, CA: AzurRxBioPharma, a company focused on the development of targeted, non-systemic therapies for Gastrointestinal (GI) diseases, recently revealed that it has reached a definitive agreement to acquire First Wave Bio(First Wave Bio) for 229 million dollars in stock and cash, including certain development, regulatory, and sales milestones. First Wave Bio is a clinical-stage biotechnology firm focused on developing innovative, gut-targeted small molecule therapeutics for auto-immune Inflammatory Bowel Diseases (IBD) and other severe diseases.

AzurRx will own full rights to First Wave Bios unique formulations of niclosamide, a small molecule medication with antiviral and anti-inflammatory effects that is targeted to treat a variety of GI diseases, under the terms of the definitive agreement. AzurRx will also be the sole owner of First Wave Bio’s extensive Intellectual Property (IP) portfolio, which covers the method of use and administration of these formulations as treatments for a variety of auto-immune, inflammatory, and viral disorders.

“The acquisition of First Wave Bio, and the creation of First Wave BioPharma, Inc. is a transformative event that significantly expands our GI development pipeline and positions our company for new growth opportunities in the inflammatory bowel disease therapeutic space,” stated Mr. Sapirstein. “Our portfolio now includes new indications for several IBDs that represent multi-billion dollar commercial market opportunities. In the U.S. last year, it is estimated that there were more than 850,000 ulcerative colitis diagnoses and 625,000 Crohns disease diagnoses, and these patient populations and markets are expected to grow substantially over the next decade. We believe that our proprietary formulations of niclosamide, with their novel anti-inflammatory mechanism of action, non-systemic absorption, and safety benefits, will enable us to address significant unmet clinical needs for IBD patients, especially in the mild-to-moderate disease categories. With our expanded pipeline and new IBD indications, we expect strong growth and increased shareholder value.”

James Pennington, M.D., Chief Medical Officer of AzurRx, commented, “There is a wealth of clinical data that supports the antiviral and anti-inflammatory capabilities of niclosamide. More recently, data generated by First Wave Bio in ulcerative proctitis supported the broader potential for niclosamide in multiple inflammatory bowel diseases where we believe our niclosamide formulations could offer significant advantages over other currently available treatments including steroids, 5-ASAs, and biologics especially in the mild-to-moderate disease stage. 

Specifically, our niclosamide formulations are orally delivered, are targeted specifically to the areas of the GI tract where the disease-causing inflammation occurs, and avoid the risk of steroid-related immunosuppressant complications. Additionally, the manufacturing process for our niclosamide products can be scaled up to supply large populations quickly."

AzurRx acquired the exclusive global rights to develop two niclosamide therapeutic indications for COVID-19-related GI infections and immune checkpoint inhibitor-associated colitis and diarrhea (ICI-AC) in advanced-stage cancer patients from First Wave Bio in January 2021. AzurRx’s internal development pipeline will encompass three additional clinical IBD indications in Ulcerative Proctitis (UP) and ulcerative proctosigmoiditis (UPS), Ulcerative Colitis (UC), and Crohn’s Disease (CD) following the purchase of First Wave Bio.

Mr. Sapirstein commented, “I’m excited about our expanded pipeline as we move into the IBD therapeutic space. We will now be advancing a pipeline that spans six indications and includes several clinical-stage programs. These programs are all built around our two proprietary technologies—niclosamide, and adrulipase (MS1819), which we are continuing to develop as a treatment for exocrine pancreatic insufficiency (EPI), a life-threatening digestive disorder seen in patients with cystic fibrosis and chronic pancreatitis. With multiple clinical trials advancing and others to soon initiate, along with a strong portfolio of long-lasting patents protecting niclosamides use for COVID-19 GI infections, ICI-AC and the IBDs, the next several years should be rich in milestones as we continue to advance our development programs, generate data, and bring new assets into the clinic.”

“This is an exciting day. We believe the acquisition of First Wave Bio by AzurRx will unlock the value of our proprietary niclosamide formulations targeting IBD. We are confident that the AzurRx team will successfully advance these programs along their respective clinical and regulatory pathways,” added Gary D. Glick, CEO, and Founder, First Wave Bio.

The transaction is being completed via a reverse triangular merger, as per the terms of the definitive agreement, and is expected to close this morning following receipt of evidence from the Secretary of State of the State of Delaware of the completion of relevant merger filings.