The clinical-stage company First Wave BioPharma (Nasdaq:FWBI) saw its share price fall by more than 40% to $0.37 in after-hours trading today after releasing new clinical trial data.
To save money, the company will initiate austerity measures, cutting headcount by about 20% and closing clinical operations site in Hayward, California and a facility in Langlade, France. “We also intend to defer certain obligations, including payment obligations related to our acquisition of First Wave Bio, Inc. (“FWB”), in order to conserve capital,” said James Sapirstein, CEO of First Wave BioPharma, in a letter to shareholders.
The study in question relates to FW-COV (niclosamide), a potential treatment for COVID-19-related gastrointestinal infections, which failed on efficacy in a Phase 2 RESERVOIR study.
First discovered in 1958, the intestinal anthelminthic niclosamide was FDA approved in 1982 as a tapeworm treatment, but has been discontinued in the U.S.
WHO cites niclosamide as an essential medicine.
The efficacy endpoint of the RESERVOIR study was to remove the SARS-CoV-2 virus from the digestive tract as confirmed in patients’ stool.
The drug, however, appeared to be safe, with no serious adverse events reported in the 150 patients in the study. “While the top-line efficacy measure from the RESERVOIR trial did not show any antiviral activity, the drug was well-tolerated without any serious adverse events,” Sapirstein said.
First Wave BioPharma said the complete data set from the study is forthcoming.
It expects full data to be available in late May.
The company has a variety of programs related to niclosamide, whose anti-inflammatory mechanism of action could prove helpful in treating diseases such as ulcerative colitis and Crohn’s disease.
In November 2021, First Wave BioPharma James Sapirstein said the company believed niclosamide targets the entire virus. The company believed then the drug would potentially be 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.”
Filed Under: Gastroenterology, Infectious Disease