First Wave BioPharma Says Independent DMC Recommends Part 2 COVID-19 RESERVOIR Study Of Niclosamide

(RTTNews) - First Wave BioPharma, Inc. (FWBI) announced Tuesday that an independent data monitoring committee (DMC) has recommended that enrollment continue in Part 2 of the ongoing RESERVOIR Phase 2 trial evaluating FW-COV as a treatment for COVID-19-related gastrointestinal (GI) infections.

FW-COV is a proprietary, oral, tablet formulation of micronized niclosamide developed to remove SARS-CoV-2 (SARS2), the virus that causes COVID-19, from the GI tract.

The DMC recommendation was based on its review of the safety data collected from the first 25 patients enrolled in Part 2 of the RESERVOIR trial. The review of the data uncovered no safety issues. Part 2 of the study will enroll up to 150 patients.

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. Patients enrolled in Part 2 of the study are randomized to receive either niclosamide or a placebo treatment for 14 days.

The efficacy of FW-COV is measured by the rate of SARS2 clearance from stool samples assessed by PCR test, comparing the niclosamide arm and the placebo arm, at six weeks, 4 month and 6-months after the 14-day period.