Biotech start-up ANA Therapeutics (ANA) reported on Tuesday the receipt of clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for ANA001 (niclosamide capsules) for the potential treatment of COVID-19.

The FDA clearance reportedly makes ANA the first US based company to conduct a human clinical trial to determine the safety and efficacy of niclosamide to treat COVID-19. It will enroll at least 400 patients with COVID-19 at ten centers across the US, including Florida and Texas, as well as plans to look at the candidate's effectiveness in treating outpatients in a later study.

In pre-clinical research, niclosamide has been shown to stop the virus that causes COVID-19 from replicating and to be more potent than remdesivir in the same assay. Furthermore, niclosamide has documented anti-inflammatory properties. The company believes niclosamide has the strong potential to both stop viral replication and reduce symptoms in patients suffering from COVID-19.

Following the outbreak of the coronavirus pandemic in the US, the company quickly raised over USD5m in March to lead the first US based clinical trial for niclosamide as a COVID-19 treatment.