Benzinga | Jan 12, 2021 08:31AM EST

AzurRx BioPharma And First Wave Bio Announce Allowance Of US Patent Application For Niclosamide As Treatment For COVID-19 Gastrointestinal Infections

* Patent allowed by the USPTO that includes claims for niclosamide as a treatment for COVID-19 GI infections

* COVID-19 GI infections are a significant unmet clinical need; AzurRx estimates potential U.S. market size of $450-600 million or greater in first year depending on how quickly the pandemic is controlled

* Phase 2 clinical study of oral niclosamide in COVID-19 planned for 1H 2021

DELRAY BEACH, Fla., Jan. 12, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX), ("AzurRx" or the "Company"), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, and First Wave Bio, Inc., ("First Wave Bio") a clinical-stage biotechnology company developing novel gut-targeted small molecules for inflammatory bowel disease and other serious conditions, today jointly announced the United States Patent and Trademark Office (USPTO) has provided a notice of allowance for issuance of a patent (U.S. patent application number 16/835,307) that covers use of niclosamide as a treatment for COVID-19-associated GI disease.

The allowed claims relate to a method for treating a digestive symptom in a subject diagnosed as having a COVID-19 viral infection comprising orally administering an effective amount of niclosamide to decrease the COVID-19 viral RNA load relative to a baseline.

One epidemiological study1 showed that COVID-19 patients admitted to the hospital with related GI symptoms progressed to severe/critical disease at a much higher rate than patients without these symptoms (22.97% vs 8.14%) and nearly 30% of patients only presented GI symptoms. The GI tract is believed to serve as a viral reservoir for SARS-CoV-2, the virus which causes COVID-19, and contributes to prolonged infection and transmission.

AzurRx and First Wave recently entered into an exclusive worldwide licensing agreement with First Wav Bio, for the use of First Wave's patented and proprietary oral and rectal formulations of niclosamide for the treatment of immune checkpoint inhibitor-associated colitis (ICI-AC) and COVID-19 GI disease. AzurRx anticipates initiating a Phase 2 trial of oral niclosamide, also called FW-1022, in patients with COVID-19, in the first half of 2021.

"We are greatly encouraged by the allowance of the patent application," said James Sapirstein, President and CEO of AzurRx BioPharma. "We believe that the FW-1022 clinical program, which supports this patent filing, has been considerably strengthened in advance of the initiation of our Phase 2 COVID-19 GI clinical trial in 1H'21. Our proprietary niclosamide formulation has the potential to benefit COVID patients by decreasing viral load in the GI tract, treating infection symptoms and preventing transmission of the virus through fecal spread."

Mr. Sapirstein continued, "We believe that there is both a significant unmet clinical need in treating COVID-19 GI infections and a substantial untapped market opportunity. It has been reported that approximately~18% of all COVID-19 cases2 have GI infections and symptoms. Based on this data, we estimate that there may be approximately 3.4 million patients having COVID GI infections in the U.S. and up to 15 million globally. We estimate that this represents a potential market size of $450-$600 million for COVID-19 GI infections in the U.S. in the first year alone if the trends continue."

"First Wave was founded to maximize the therapeutic potential of proprietary forms of niclosamide, and the biology underlying COVID-19 is highly aligned with the mechanism of our gut-targeted suite of niclosamide-derived therapies in development," said Gary D. Glick, Ph.D., Co-Founder and Chief Executive Officer of First Wave Bio. "Our novel approach and compelling translational data have delivered a strong intellectual property estate, including this landmark issuance for our field."