Benzinga | Jan 4, 2021 07:05AM EST

AzurRx BioPharma Announces Exclusive Worldwide License Agreement with First Wave Bio for Use of Proprietary Niclosamide Formulations to Treat Immune Checkpoint Inhibitor-Associated Colitis and COVID-19 Gastrointestinal Infections

* Agreement expands AzurRx's pipeline of targeted, non-systemic GI therapies

* Clinical trials to initiate in 1H'21, with potential for expedited FDA 505(b)(2) pathway for IND-approved COVID-19 and breakthrough designation for immune checkpoint colitis programs

* Management to discuss the agreement with First Wave Bio and the company's two new clinical programs on a call scheduled for today, Monday, January 4, 2021, at 8:30 a.m. Eastern Time

DELRAY BEACH, Fla., Jan. 04, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX), ("AzurRx" or the "Company"), a company specializing in the development of non-systemic therapies for gastrointestinal (GI) diseases, today announced that it has signed an exclusive worldwide licensing agreement with First Wave Bio, Inc. ("First Wave") for the use of their patented and proprietary oral and rectal formulations of niclosamide for the treatment of immune checkpoint inhibitor-associated colitis (ICI-AC) and COVID-19 GI infections.

Niclosamide is a small molecule drug that was approved by the FDA in 1982 for the treatment of intestinal tapeworm infections and is on the World Health Organization's (WHO) list of essential medicines. It has been safely used by millions of patients and is being investigated as a potential new therapy for inflammatory diseases and viral infections. Founded in 2015, First Wave has invested in translational biology along with process development and manufacturing to develop proprietary oral and rectal gut-targeted formulations of niclosamide for the treatment of ICI-AC, COVID-19 GI-infections, and inflammatory bowel disease (IBD).

"The acquisition of rights to niclosamide for these indications gives us an opportunity to strategically expand our existing pipeline and pursue multiple GI indications in the oncology and infectious disease arenas," said James Sapirstein, President and Chief Executive Officer of AzurRx. "We are impressed with First Wave's Phase 1b/2a clinical data, strong IP and patent position, and the significant unmet medical needs and market opportunities addressed by these two assets. We believe these niclosamide formulations could offer significant advantages over other currently available treatments. They are not systemically absorbed, potentially allowing for higher local GI concentrations of drug delivery and avoiding steroid-related immunosuppressant complications."

Mr. Sapirstein continued, "With these new assets, combined with our current pipeline, we believe 2021 will be a very exciting and transformational year for AzurRx. AzurRx is on track to report top-line data for its two Phase 2 MS1819 clinical trials in the first and second quarters of 2021 and anticipates initiating both the Phase 2 COVID-19 GI Infection trial and a Phase 1b/2a ICI-AC trial in the first half of 2021."

Gary D. Glick, Ph.D., Co-Founder and Chief Executive Officer of First Wave Bio, added "The license of our niclosamide technology for the immune checkpoint inhibitor and COVID indications is a significant milestone for our company and we are very pleased to have found a clinical and commercial development partner in AzurRx. We look forward to working with the AzurRx team to take our novel niclosamide therapies to the clinic in 2021 and to rapidly bringing these therapies to cancer and COVID-19 patients."

Under the terms of the agreement, AzurRx is granted a worldwide, exclusive right to develop, manufacture, and commercialize First Wave's proprietary immediate release oral and enema formulations of niclosamide for the treatment of ICI-AC and COVID-19 GI infections. First Wave will receive an upfront payment of $10.25 million in cash payable $9.0 million at closing and $1.25 million by June 30, 2021 and $3.0 million of Convertible Junior Preferred Stock, which shall be convertible into common stock following shareholder approval, and up to $74.0 million in potential development and commercial milestones, as well as mid single-digit royalties on product sales for the ICI-AC and COVID-19 GI indications.

H.C. Wainwright & Co. is acting as financial advisor to AzurRx in connection with the licensing transaction.