Silicon Valley-based biotech start-up ANA Therapeutics announced Tuesday that the Food and Drug Administration (FDA) approved its application for tapeworm drug niclosamide as a potential treatment in COVID-19 and will soon begin human clinical trials.
The move makes ANA Therapeutics the first U.S.-based-company to run a clinical trial for niclosamide to determine efficacy in COVID-19, officials said.
The FDA cleared its investigational new drug application for ANA001, niclosamide capsules, the company said in a press release.
As of Tuesday, the first patient had not been enrolled, spokesperson Elizabeth Squire told Fox News in an email statement.
Niclosamide is approved by the FDA to treat tapeworm infections, and kills the worms on contact, according to the Mayo Clinic. In pre-clinical research, the drug was said to stop the virus that causes COVID-19 from replicating and showed more potency than Gilead Sciences' remdesivir in the same assay. Niclosamide also documented anti-inflammatory properties, officials said.
“ANA Therapeutics believes niclosamide has the strong potential to both stop viral replication and reduce symptoms in patients suffering from COVID-19,” company officials wrote in a press release.
“Safe and effective antiviral therapies are critically needed to treat COVID-19 now and treatments will continue to be necessary even if a vaccine is developed," said Akash Bakshi, ANA Therapeutics co-founder and CEO.
“Anticipating that niclosamide may prove to be effective against COVID-19, we are already laying plans to make the drug accessible to everyone," Bakshi said.
The clinical trial seeks to enroll at least 400 patients with COVID-19 at 10 centers across the U.S., specifically in states experiencing a surge in cases, such as Florida and Texas.
ANA Therapeutics will set out to evaluate the safety of niclosamide and its ability to improve hospitalized patients, focusing on less severe patients who are not on ventilators.
Patients will be given a seven-day course of the drug and monitored for 60 days. ANA Therapeutics will examine the drug’s effectiveness in treating outpatients in a later study.
In early March, ANA pivoted the business to determine the efficacy of niclosamide for COVID-19 and raised more than $5 million to lead the clinical trial.