Benzinga | Jun 7, 2021 07:04AM EDT

AzurRx BioPharma Doses First Patient In Phase 2 Clinical Trial of Niclosamide for the Treatment of COVID-19 Gastrointestinal Infections

AzurRx BioPharma, Inc. (NASDAQ:AZRX), ("AzurRx" or the "Company"), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced today the administration of the first dose of FW-1022 to a volunteer in the ongoing Phase 2 RESERVOIR clinical trial. FW-1022 is a proprietary oral tablet formulation of micronized niclosamide developed for the treatment of COVID-19-related GI infections. Topline results from the trial are expected in the first quarter of 2022.

"Dosing the first patient in the RESERVOIR clinical trial marks a significant milestone for AzurRx and the development of niclosamide as a potential treatment for COVID-19-related GI infections," said James Sapirstein, Chief Executive Officer of AzurRx BioPharma. "There are currently no approved treatments available for COVID-19-related GI infections. If our development program is successful, we believe that FW-1022 could help prevent reinfection and the spread of COVID-19, as well as treat certain potentially severe complications that many people believe to be caused by the ability of SARS-CoV-2 to hide in reservoirs within the GI tract. We believe our micronized oral niclosamide therapy has the potential to target the virus directly in the gut and play an important role in treating COVID-19 patients experiencing the damaging aftereffects of COVID-19-related GI infection."

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 (rectal swab or stool sample) assessed by RT-PCR, comparing the niclosamide arm to the placebo arm for up to six months. These long-term observation data could indicate that niclosamide treatment has the potential to improve "long haul" COVID-19 symptoms.

"As a practicing clinician, I have treated hundreds of COVID-19 patients with many reporting GI issues resulting from the virus, including severe diarrhea, vomiting and abdominal pain. However, COVID-related GI infection remains an underappreciated and often untreated aspect of the disease despite its prevalence and adverse impact on the patient," said Salma Saiger, M.D., of SMS Clinical Research, LLC and an investigator with the RESERVOIR clinical trial. "Given this, there is a pressing need to develop therapeutics to directly treat SARS-CoV-2 that may be hiding in the GI tract. Preclinical evidence suggests that micronized niclosamide could provide such an opportunity, and I am excited to be part of the investigative team researching the drug in the Phase 2 RESERVOIR trial."

"Evidence continues to build in support of niclosamide as a potential COVID-19 therapy, including research from the Institut Pasteur Korea suggesting that niclosamide could be 40 times more potent than remdesivir in inhibiting SARS-CoV-2," said James Pennington, M.D., Chief Medical Officer of AzurRx. "We believe FW-1022, our micronized formulation of niclosamide, is ideally equipped to clear SARS-CoV-2 hiding in the gut due to its proven safety profile and known effectiveness in treating other GI ailments, and its ability to remain in the gut for long periods of time. We look forward to reporting topline data from RESERVOIR in early 2022."

More information about this clinical trial is available at ClinicalTrials.gov.