Benzinga | Jan 6, 2022 07:02AM EST

First Wave BioPharma Completes Enrollment For Part 2 of RESERVOIR Phase 2 Trial Evaluating FW-COV In COVID-19-Related GI Infections

First Wave BioPharma, Inc., (NASDAQ:FWBI), ("First Wave BioPharma" or the "Company"), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that it has completed enrollment for Part 2 of the RESERVOIR Phase 2 trial evaluating FW-COV as an outpatient treatment for COVID-19-related gastrointestinal (GI) infections. FW-COV is a proprietary, oral, tablet formulation of micronized niclosamide being developed to remove SARS-CoV-2 (SARS2), the virus that causes COVID-19, from the GI tract.

RESERVOIR is designed as a two-part, two-arm, randomized, placebo-controlled Phase 2 study with a primary purpose to confirm the safety of FW-COV and assess the drug's ability to remove the SARS-CoV-2 (SARS2) virus from the digestive tract. The 150 patients successfully enrolled in Part 2 of the trial were randomized to receive either FW-COV or a placebo treatment for 14 days and will be observed for six weeks following the end of treatment. No FW-COV drug-related serious adverse events (SAEs) have been reported from the trial participants. First Wave BioPharma expects to report top-line data in the first half of 2022.

"We are very pleased to complete enrollment of the second part of the RESERVOIR trial and look forward to reporting top-line data in the coming months," stated James Sapirstein, President and CEO of First Wave BioPharma. "This is an important milestone for First Wave and the development of FW-COV. Based on the positive safety data observed thus far, combined with earlier published in vitro COVID efficacy data1 for niclosamide, we believe that FW-COV has the potential to contribute to the global need for new therapies against SARS2. Furthermore, because niclosamide targets the entire virus, and not just the spike protein, we believe that FW-COV may prove effective against multiple strains of COVID-19, including the Delta and Omicron variants. If RESERVOIR is successful and supported by additional data, we anticipate being in a position to submit an Emergency Use Authorization (EUA) application later this year."

James Pennington, M.D., Chief Medical Officer of First Wave BioPharma, commented, "Safety data thus far indicates that our micronized oral niclosamide therapy is well tolerated, and we believe that further data will demonstrate that FW-COV can add a much-needed new oral anti-viral therapy to the COVID-19 treatment regimen. Millions of patients around the world already suffer complications from COVID-19, and millions more could face similar medical issues as the Omicron variant continues to fuel a surge in new infections."

Additional information about the RESERVOIR trial can be found at www.covidgi.com and on ClinicalTrials.gov.