AzurRx acquires First Wave, then changes its name
Riding the Wave
In September Boca Raton, Florida-based AzurRx BioPharma, Inc., which specializes in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, acquired First Wave Bio, Inc., a clinical-stage biotechnology company specializing in the development of novel, gut-targeted, small molecule therapies for auto-immune inflammatory bowel diseases (IBD) and other serious conditions.
The acquisition involved a stock and cash transaction valued at $229 million, including certain development, regulatory and sales milestones. Now AzurRx has changed its name to First Wave BioPharma. AzurRx’s management team, including James Sapirstein, chairman, president and chief executive officer, will continue to lead the renamed company.
According to Sapirstein, “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. 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 Crohn’s disease diagnoses, and these patient populations and markets are expected to grow substantially over the next decade.”
He added, “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.”
Niclosamide is a prescription small molecule drug listed as an essential medicine by the World Health Organization (WHO). Niclosamide has been safely used by millions of patients for several clinical indications. In the U.S., niclosamide was approved by the U.S. Food and Drug Administration (FDA) in 1982 for the treatment of intestinal tapeworm infections. In addition to its antihelminthic activity, niclosamide has demonstrated anti-inflammatory and anti-viral properties.
The renamed company now has all rights to First Wave Bio’s proprietary formulations of niclosamide, designed to address multiple GI conditions. It also has sole ownership of First Wave Bio’s robust intellectual property (IP) portfolio, which covers method of use and delivery of these formulations as treatments for various auto-immune, inflammatory and viral conditions.
In January 2021, AzurRx in-licensed from First Wave Bio the exclusive global rights to develop two niclosamide therapeutic indications – for COVID-19-related GI infections, and for immune checkpoint inhibitor-associated colitis and diarrhea (ICI-AC) in advanced stage cancer patients. Following the acquisition of First Wave Bio, AzurRx’s internal development pipeline will include three new clinical IBD indications in ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS), ulcerative colitis (UC), and Crohn’s disease (CD).
James Pennington, M.D., chief medical officer of AzurRx, said, “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.”
Sapirstein added, “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 niclosamide’s 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.”
Gary D. Glick, CEO and founder of First Wave Bio, said, “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.”
First Wave BioPharma has begun screening patients for enrollment in a Phase 2b clinical trial investigating a topical formulation of FW-UP as a potential treatment for ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS). FW-UP is a proprietary topical formulation of niclosamide, a small molecule anti-inflammatory inhibitor therapy. UP and UPS are two types of ulcerative colitis, a chronic inflammatory bowel disease (IBD) consisting of fine ulcerations in the inner mucosal lining of the large intestine that do not penetrate the bowel muscle wall.
“Advancing the clinical development of FW-UP in ulcerative proctitis and ulcerative proctosigmoiditis to a Phase 2b trial marks an important milestone in our niclosamide pipeline and our overarching mission to bring relief to patients living daily with gastrointestinal disease,” Sapirstein said. “Our recently completed acquisition of First Wave Bio added new growth opportunities in the inflammatory bowel disease space where we are exploring the use of niclosamide and its anti-inflammatory properties in several indications. Ulcerative proctitis and ulcerative proctosigmoiditis are two of several IBD indications where we believe our proprietary formulations of niclosamide could address the significant underserved needs of this very large and growing patient population.”
The Phase 2b trial is a placebo-controlled study that will enroll as many as 28 patients to compare FW-UP, administered as an enema twice daily at a dose of 450 mg, to placebo enemas twice daily. Patient screening is underway at clinical trial sites in Italy and will start soon in Austria and Germany. The Phase 2b trial builds on preliminary data from a previous Phase 1a/2a trial evaluating a low-dose (150 mg/twice daily) and high-dose (450 mg/twice daily) of FW-UP in patients with UP and UPS. Data from the first 17 patients treated in the low-dose cohort demonstrated niclosamide to be well tolerated, with a durable therapeutic effect and a clinical remission rate of 59%. Although from early stage data, this rate of remission compares favorably to the rates of 38% to 44% reported for the commonly used steroid, budesonide. In data collected from the first four patients in the high-dose cohort, niclosamide was also shown to be well tolerated.
Pennington concluded, “There is a great deal to be excited about with the clinical data collected thus far investigating niclosamide’s use in UP and UPS. The drug was well tolerated at both low and high doses, and the data suggest that niclosamide could be more effective than the standard of care corticosteroid. This marks the first proof of principle for niclosamide as a treatment for an IBD. Our plan with the Phase 2b study is to determine whether higher doses of niclosamide have the potential to deliver even better results for patients.”