AzurRx BioPharma Engages PPD to Manage Clinical Trial for Niclosamide as Treatment for COVID-19 Gastrointestinal Infections
February 09, 2021 at 06:30 AM EST
Phase 2 Study of oral niclosamide planned for 1H 2021
DELRAY BEACH, Fla., Feb. 09, 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, announced today that it has entered into an agreement with PPD, Inc. (NASDAQ: PPD), a leading global contract research organization (CRO), for its planned Phase 2 clinical trial evaluating a proprietary formulation of micronized niclosamide as a treatment for COVID-19-associated gastrointestinal (GI) infections.
Under the terms of the agreement, PPD will manage the Phase 2 clinical trial for an immediate-release capsule formulation of micronized oral niclosamide, also known as FW-1022. Licensed by AzurRx in January from FirstWave Bio, Inc., the goal of AzurRx’s FW-1022 clinical program is to develop a safe, effective, non-systemic treatment for GI infections related to COVID-19. AzurRx anticipates initiating the trial in the first half of 2021.
“We are moving rapidly to initiate the planned Phase 2 trial of FW-1022 and are pleased to have PPD as our CRO partner given the company’s proven expertise and track record of clinical excellence,” said James Sapirstein, President and CEO of AzurRx BioPharma. “Even as the vaccine rollout continues, millions of people will become infected with the SARS-CoV-2 virus, and recent study data suggest approximately 1 in 5 of those stricken will suffer COVID-related GI infections with symptoms that include loss of appetite, nausea, vomiting and diarrhea. There is no therapeutic available to treat this condition, and we believe FW-1022 offers the potential to address this serious and possibly long-lasting after-effect of COVID-19.”
Daniel Burch, M.D., Senior Vice President and Global Head of PPD® Biotech, stated, “PPD is pleased to support AzurRx’s efforts to bring relief to patients suffering from COVID-19-related GI infections. We recognize the breakthrough nature of AzurRx’s work with FW-1022 and look forward to applying our capabilities and expertise to the development of FW-1022, beginning with the planned Phase 2 clinical trial.”
About COVID-19 Gastrointestinal Infections
There is some evidence to support the view that the GI tract is a possible reservoir for recurrence and fecal spread of the COVID-19 virus as ACE-2, the entry receptor for COVID-19, is highly expressed on GI cells. There currently is no targeted treatment for COVID GI infections.
There remains an urgent need to develop new medicines that can be manufactured at large scale quickly to treat COVID-19. Niclosamide was recently identified by the Institut Pasteur Korea as a potent inhibitor of SARS-CoV-2, the virus causing COVID-19, with potency 40X greater than remdesivir.2 Additionally, emerging evidence confirms the severe GI-related complications of COVID and potential fecal spread of the virus. The Company’s clinical trials may establish that patients treated with an oral and non-systemic niclosamide formulation that delivers high local GI concentrations have decreased viral load and GI-associated symptoms of COVID. Importantly, the manufacturing process for niclosamide can be scaled up to supply large populations quickly.
About AzurRx BioPharma, Inc.
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1 Gut Journal: Vol 69, Issue 6: 2020; Gut Journal: Vol 69, Issue 6: 2020; JAMA Network: Vol 3, Issue 6: 2020; Lancet Gastroenterol Hepatol: Vol 5, Issue 5: 2020; Cheung Gastroenterology: Vol. 159, Issue 1: 2020