AzurRx BioPharma activates new clinical trial sites in India
AzurRx BioPharma, Inc., a company focused on the development of non-systemic targeted therapies for gastrointestinal (GI) diseases, announced today the activation of seven (7) new clinical trial sites in India for the ongoing RESERVOIR trial evaluating FW-1022. FW-1022 is a patented oral tablet formulation of micronized niclosamide that was created for the treatment of gastrointestinal infections associated with COVID-19.
Together with the eleven current sites in the United States and the five recently added sites in Ukraine, the seven new clinical trial sites in India increase the total number of RESERVOIR trial sites to twenty-three. AzurRx anticipates reporting financial results in the first quarter of 2022.
“By expanding our clinical trial into India, we get access to the world's second most populated country, which is still battling a devastating COVID-19 outbreak,” said James Sapirstein, President and CEO of AzurRx BioPharma. “Despite global immunisation efforts, COVID-19 and its new Delta form continue to be virulent. In India, infection rates average 38,000 each day, with over 31.1 million persons infected in total. Although the virus's effect on the GI tract is sometimes overshadowed by its effect on the respiratory system, COVID-19-related GI illness continues to be a neglected symptom with fatal consequences. For the millions who have contracted and continue to contract the virus, a safe and effective treatment that eliminates the virus from the gut is required.”
RESERVOIR is a two-part, two-arm, placebo-controlled Phase 2 study. The primary objectives of the trial are to establish the safety of FW-1022 in patients with COVID-19-related gastrointestinal infections and to assess its efficacy in clearing SARS-CoV-2, the virus that causes COVID-19, from the GI tract. The RESERVOIR trial's major effectiveness measure is the rate of faecal SARS-CoV-2 clearance (stool sample) as determined by RT-PCR, comparing the niclosamide arm to the placebo arm for up to six weeks. These long-term observational findings may suggest that niclosamide medication has the ability to ameliorate COVID-19 symptoms over the long term. The study's preliminary findings are expected in the first quarter of 2022.