First Wave BioPharma Announces Independent Data Monitoring Committee Provides Positive Interim Safety Assessment for Part 2 COVID-19 RESERVOIR Clinical Trial of Niclosamide for the Treatment of Gastrointestinal Infections

First Wave BioPharma, Inc., a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced 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.

James Sapirstein, President and CEO of First Wave BioPharma, stated, “The DMC’s review of interim safety data was very positive with no substantive safety issues documented in the initial 25 patients dosed in Part 2 of the RESERVOIR trial. This news comes at a critical time in the COVID-19 pandemic with the rise of the fast-spreading Omicron variant, declared last week by the World Health Organization as a variant of concern. 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 and may provide an effective therapeutic to help millions of COVID-19 patients overcome the debilitating and often overlooked effect the virus can have on the GI system. Based on current timelines and pacing of enrollment, which is strong, we expect to report topline results from the RESERVOIR trial next year, including an assessment of FW-COV’s ability to clear the COVID-19 virus 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. Patients enrolled in Part 2 of the study are randomized to receive either niclosamide or a placebo treatment for 14 days. After 14 days, patients will cease treatment but remain under observation for up to six weeks, with additional follow-up observations at 4 month and 6-months to assess persistence or recurrence of symptoms. 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. Long-term observation could indicate whether niclosamide treatment has the potential to prevent “long haul” COVID-19 symptoms.

James Pennington, M.D., Chief Medical Officer of First Wave BioPharma, commented, “Despite vaccination campaigns and booster shots, COVID-19 and its growing family of dangerous variants continue to spread, and the virus’ lingering effects have developed into a major medical issue for millions of people. Research suggests SARS2 may form reservoirs in the GI tract and cause illness long after the abatement of the initial infection. Early data demonstrated that our micronized oral niclosamide therapy is well tolerated, and we believe that FW-COV may have the ability to remove these viral reservoirs from the GI tract, adding a much needed drug to the COVID treatment regimen.”