AzurRx BioPharma, Inc., a company specializing in the development of targeted non-systemic, recombinant therapies for gastrointestinal (GI) diseases, announced the completion of site initiation visits and the addition of five (5) new clinical trial sites in Ukraine for the ongoing RESERVOIR Phase 2 clinical trial evaluating FW-1022 as a treatment for COVID-19-related gastrointestinal (GI) infections. FW-1022 is a proprietary oral tablet formulation of micronized niclosamide developed for the treatment of COVID-19-related GI infections.
The RESERVOIR clinical trial is designed as a two-part, two-arm, placebo-controlled Phase 2 study. The trial’s primary objectives are to confirm the safety of FW-1022 in the treatment of patients with COVID-19-related GI infections and to evaluate its efficacy in clearing SARS-CoV-2 from the GI tract. The primary efficacy measure of the RESERVOIR trial is the rate of fecal SARS-CoV-2 clearance (stool sample) assessed by RT-PCR, comparing the niclosamide arm to the placebo arm for up to six weeks. These long-term observation data could indicate that niclosamide treatment has the potential to improve “long haul” COVID-19 symptoms. Topline data from the study is anticipated during the first quarter of 2022.
“Niclosamide represents an important advance in the fight to help COVID-19 patients overcome the debilitating and often overlooked effect the virus can have on the GI system,” said James Sapirstein, Chairman, CEO and President of AzurRx BioPharma. “While vaccines have been delivered to millions of people, COVID-19, and, in particular, the highly infectious Delta variant, remains a significant concern, especially in regions of the U.S. and areas of the world where vaccination rates are low. The addition of new trial sites in Ukraine provides enhanced opportunity to enroll patients in a country where less than 5% of the population is fully vaccinated for COVID-19.”
“FW-1022 is an orally delivered, non-systemic formulation of niclosamide that is designed to deliver high concentrations of the drug directly to the GI tract,” said Dr. James Pennington, Chief Medical Officer of AzurRx BioPharma. “We believe these properties have the potential to decrease viral load and GI-associated symptoms of COVID and look forward to accelerating the progress of the RESERVOIR trial to, hopefully, introduce the first therapeutic specifically designed to treat COVID GI infections.”
Additional information about the RESERVOIR trial can be found at the www.covidgi.com website and on ClinicalTrials.gov.
The RESERVOIR trial is being managed by PPD, Inc., a leading global contract research organization (CRO). AzurRx is also developing a proprietary formulation of micronized niclosamide (FW-420) as a treatment for immune checkpoint inhibitor-associated colitis.
About COVID-19 Gastrointestinal Infections
Gastrointestinal infection symptoms (severe diarrhea, vomiting and abdominal pain) have been reported in approximately 18% of COVID-19 cases.1 Of the 33 million individuals who are reported to have contracted COVID-19 in the U.S.,2 this would translate into 6 million patients having GI infection. Of the 165 million cases globally,3 it would translate into almost 30 million patients. Furthermore, approximately 10% of patients who were infected with COVID have persistent symptoms months after their initial diagnosis.3 Approximately 86% of these COVID “long haulers” are reported to have GI infection symptoms, with 60% continuing to have diarrhea months after their initial infection.4
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.
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.5 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.
AzurRx BioPharma, Inc. is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of two gut-restricted GI assets in three clinical indications. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis. AzurRx is also advancing two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor: FW-1022, for COVID-19 gastrointestinal infections and FW-420, for grades 1 and 2 Immune Checkpoint Inhibitor-associated colitis and diarrhea in oncology patients. The Company is headquartered in Boca Raton, Florida with clinical operations in Hayward, California.