DALLAS (WBAP/KLIF)- Covid-19 patients in DFW will be the first to participate in a series of nation-wide phase 2 clinical studies to treat gut infections caused by the virus.
Biopharmaceutical company AzurRx is seeking to enroll patients for a drug to treat gastrointestinal (GI) infection symptoms associated with COVID-19, including severe diarrhea, vomiting and abdominal pain. Under the direction of Dr. Salma Saiger from SMS Clinical research, patients in the Dallas-Ft. Worth will participate in the RESERVOIR trial, that is designed to evaluate the safety and efficacy of an oral drug, FW-1022 (a proprietary formulation of niclosamide from AzurRx Bio Pharma) to treat COVID-19 related GI infections. FW-1022 has the potential to benefit COVID-19 patients by decreasing viral load in the GI tract, treating infection symptoms, and preventing transmission of the virus through fecal spread.
“Initiation of the Phase 2 clinical trial of FW-1022 for the treatment of COVID-19 GI infection, or the RESERVOIR trial, is a significant milestone for AzurRx and an important advance in the ongoing battle to help those infected by COVID-19 to overcome the often long-lasting effects of the virus,” said James Sapirstein, Chairman, CEO and President of AzurRx BioPharma. “COVID-19 is a pernicious disease and, despite the ongoing vaccine rollout, one that continues to impact hundreds of thousands of people worldwide every day in addition to the millions who have already been infected. For many, the after-effects of COVID-19 can be as bad as the disease itself, and this includes a growing number who experience severe GI complications due to what many believe is the ability of SARS-CoV-2 to hide in reservoirs within the GI tract. We believe micronized oral niclosamide has the potential to target SARS-CoV-2 directly in the gut and, doing so, become an important addition to the armamentarium of therapeutics that will unfortunately be required by many who contract COVID-19.”
While more than 70 million people are now vaccinated in Texas and COVID-19 rates have dropped in the area, people are still contracting the virus, people are still being hospitalized, and people are still dying, according to Dr. Salma Saiger, who has been treating patients locally through her internal medicine practice where clinical trials for COVID-19 have also been underway for the last year.
“Diarrhea that lasts 3-7 days has been a very prominent symptom that is present in at least 50% of the patients I have seen over the last year. Diarrhea adds to patients’ weakness because it causes dehydration and further exhausts them and puts them at greater risk for more serious illness. It is also the most underreported symptom, as attention has been focused on respiratory, sense of taste/smell and cardiac symptoms,” said Saiger.
In addition to causing debilitating symptoms in patients suffering from COVID-19, there is emerging evidence that the SARS-CoV-2 virus that causes COVID-19 can remain trapped in the GI tract. If left untreated, this can cause recurrence and fecal spread of the virus and may contribute to Long COVID. No treatment for COVID infections of the GI tract is currently available and there is an urgent need to reduce the potential for recurrence and hospital spread.
To learn more about AzurRx and to enroll in the study, visit https://azurrx.com/