AzurRx BioPharma Inc. (NASDAQ: AZRX) has announced approval from the independent data monitoring committee to commence enrolment of patients in the second part of its ongoing RESERVOIR phase 2 clinical study evaluating FW-1022 in COVID-19-associated gastrointestinal infections treatment.
FW-1022 developed to treat the COVID-19 virus in the GI tract
FW-1022 is a novel oral tablet micronized niclosamide formulation the company developed to remove SARS-CoV-2, which is the virus that causes coronavirus from the gastrointestinal tract. The committee used safety data from nine patients enrolled in the first part of the RESERVOIR study to make the recommendation. In Part 2 of the study, the company will enroll 150 patients in sites across India, Ukraine, and the US to demonstrate the efficacy of FW-1022 in treating COVID-19 from the GI tract.
CEO James Sapirstein said, “We greatly appreciate the thoughtful analysis and guidance provided by the DMC following its review of the data from Part 1 of the RESERVOIR trial. Consistent with our expectations, the early safety data supports the continued exploration of FW-1022 and the committee has recommended that we continue to Part 2 of the trial without modification. This marks an important step in our efforts to advance the development of FW-1022 and our broader goal to bring relief to the millions of COVID-19 patients – roughly 18% or one out of every six – fighting the debilitating and discomforting gastrointestinal symptoms caused by the virus.”
AzurRx submits IND to commence study on colitis and diarrhea in cancer patients
Recently the company submitted an Investigational New Drug Application to commence clinical studies evaluating the novel niclosamide formulation for Grade 1 & 2 colitis and diarrhea in cancer patients receiving immune checkpoint inhibitors treatment.
Sapirstein said, “We look forward to working with the FDA to advance the clinical development of FW-420 as a safe, effective and non-systemic treatment addressing immune checkpoint inhibitor-associated colitis (ICI-AC), a potentially dangerous side effect of cancer treatment involving immune checkpoint inhibitors.”
