AzurRx BioPharma Inc. (AZRX) stock declined by 3.92% at the last trading close whereas the AZRX stock gains by 2.04% in the pre-market trading after AZRX announced that they have started their Phase 2 RESERVOIR clinical trial of a proprietary oral formulation of micronized niclosamide. AzurRx BioPharma is a clinical-stage biopharmaceutical company focused on developing non-systemic, therapeutic strategies for gastrointestinal (GI) diseases.
What is happening?
Today AzurRx BioPharma announced that it has started the RESERVOIR Phase 2 clinical trial of a proprietary oral formulation of micronized niclosamide for the prevention of COVID-19-related GI infections. Patient registration is set to begin in April 2021, with topline results expected in the first quarter of 2022.
The RESERVOIR Phase 2 clinical trial of AZRX stock is a two-part, two-arm, placebo-controlled study that looks at the safety and effectiveness of micronized oral niclosamide tablets, also known as FW-1022, in patients with COVID-19 GI infection. The primary goals of this study would be to confirm the safety of niclosamide in the treatment of COVID-19 GI infection in patients and also to show that it has the ability to clear the SARS-CoV-2 virus from the GI tract.
The rate of fecal SARS-CoV-2 virus clearance (rectal swab or stool sample) measured by RT-PCR in the RESERVOIR trial is the primary efficacy indicator, with the niclosamide arm compared to the placebo arm for up to six months. These long-term data suggest that niclosamide treatment can help with COVID-19 symptoms in the long run.
The Chief Medical Officer of AzurRx, Dr. James Pennington said that Long-haul COVID cases are becoming a big problem around the world, and it’s fair to believe the GI tract may be acting as a silent reservoir. Because of its validated safety profile, known efficacy in treating other GI ailments, and exceptional ability to stay in the gut for extended periods of time, the team at AZRX stock assumes that niclosamide is ideally suited to remove these secret GI SARS-CoV-2 reservoirs. AZRX’s micronized niclosamide formulation, which allows for localized concentrations in the gutwill enhance these properties.