AzurRx BioPharma has entered into an agreement with PPD 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, 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.”
“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,” Daniel Burch, M.D., Senior Vice President and Global Head of PPD® Biotech, said.
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Gastrointestinal infection symptoms have been reported in approximately 18% of COVID-19 cases. Of the 26.6 million individuals who are reported to have contracted COVID-19 in the U.S., this would translate into 4.8 million patients having GI infection. Of the 105 million cases globally, it would translate into almost 19 million patients.
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.
Niclosamide is a prescription small molecule drug listed as an essential medicine by the World Health Organization (WHO). Niclosamide has been safely used on millions of patients for other 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.
FW-1022 is a niclosamide based small molecule which the Company’s clinical trials may establish has anti-viral activity that is effective for the treatment of SARS-CoV-2 (COVID-19) gastrointestinal infections. FW-1022 will be supplied as an oral immediate release tablet. The formulation to be used has been milled (micronized) to allow superior dissolution in the gut fluids. This in turn may allow local niclosamide concentrations to reach anti-viral levels. Thus, FW-1022 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.