August 5, 2020 -- ANA Therapeutics said that the U.S. Food and Drug Administration has cleared its investigational new drug application for ANA001 (niclosamide capsules) as a potential COVID-19 treatment.
As a result, ANA will be the first U.S.-based company to conduct a human clinical trial for determining the efficacy of niclosamide in treating COVID-19, according to the firm. The clinical trial will seek to enroll at least 400 COVID-19 patients at 10 centers in the U.S., specifically in states such as Florida and Texas that are experiencing surges in cases.
In the trial, ANA will evaluate the safety of niclosamide, as well as its ability to demonstrate a clinical improvement in hospitalized COVID-19 patients. The study will focus on patients with less-severe symptoms who are not on ventilators, according to the company.
Patients will be given a seven-day course of niclosamide and monitored for 60 days. The first patient is expected to be enrolled in August. The firm said it also plans to assess niclosamide's effectiveness in treating outpatients in a later study.