- First Wave BioPharma Inc (NASDAQ:FWBI) shares are plummeting after the company reported topline data from Phase 2 RESERVOIR trial of FW-COV, oral formulation of niclosamide, for COVID-19-related GI infections.
- FW-COV was very safe, with no serious adverse events reported by the more than 150 patients who participated in the trial.
- But FW-COV's ability to remove the SARS-CoV-2 virus from the digestive tract – did not demonstrate statistical significance compared to the placebo.
- Related: First Wave BioPharma Stock Jumps On Niclosamide's Favorable Safety Profile In COVID-19 Related GI Infections.
- The company is still awaiting the complete data set for analysis, including anti-inflammatory biomarkers, abdominal discomfort changes, and medium-term safety follow-up.
- First Wave BioPharma anticipates reporting the full data set in late May, along with the next steps for the FW-COV program.
- The company says that while the topline efficacy measure from the RESERVOIR trial did not show any anti-viral activity, the drug was well-tolerated without any serious adverse events.
- "We believe this will continue to be the case for our ongoing clinical program of niclosamide (FW-UP) as a potential treatment for patients with ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS)," writes James Sapirstein
- Chairman, President & CEO.
- First Wave BioPharma will reduce its headcount by 20% and close the West Coast office and facility in Langlade, France.
- Price Action: FWBI shares are down 36.3% at $0.40 during the premarket session on Monday's last check.
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