ANA Therapeutics Announces U.S. FDA Clearance Of IND Application To Initiate Clinical Trial Of Niclosamide In COVID-19 Patients

FOSTER CITY, Calif., Aug. 4, 2020 /PRNewswire/ -- ANA Therapeutics (ANA), a Silicon Valley-based biotech start-up announced today that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for ANA001 (niclosamide capsules) as a potential treatment for COVID-19, making it the first U.S.-based company to conduct a human clinical trial to determine the efficacy of niclosamide to treat COVID-19.

ANA Therapeutics clinical trial will seek to enroll at least 400 patients with COVID-19 at 10 centers across the U.S., specifically in states that are experiencing surges in coronavirus cases such as Florida and Texas and expects to enroll the first patient in August. ANA will evaluate both the safety of niclosamide as well as its ability to show a clinical improvement in hospitalized patients with COVID-19. This study will focus on patients with less severe symptoms who are not on ventilators. During the trial, patients will be given a seven-day course of niclosamide and monitored for 60 days. ANA Therapeutics plans to look at niclosamide's effectiveness in treating outpatients in a later study.

"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. This will be the first U.S.- based clinical trial to determine the efficacy of niclosamide in COVID-19," ANA Co-Founder and CEO Akash Bakshi said. "Anticipating that niclosamide may prove to be effective against COVID-19, we are already laying plans to make the drug accessible to everyone."

Niclosamide has been used for more than 50 years to safely treat millions of people worldwide with its primary indication being the treatment of tapeworm infections. Now, niclosamide has emerged as a promising candidate to combat COVID-19. 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. Therefore, ANA Therapeutics believes niclosamide has the strong potential to both stop viral replication and reduce symptoms in patients suffering from COVID-19.

"As a start-up and unlike large life science companies, ANA Therapeutics has already moved at lightning speed to get niclosamide into clinical trials," said Sam Altman, former president of Y Combinator and now the CEO of OpenAI. "I'm thrilled to invest in the team's critically important mission to develop a safe, effective, and widely available treatment for COVID-19."

In early March, at the outset of the coronavirus pandemic in the U.S., ANA pivoted their business to determine the efficacy of niclosamide for COVID-19 and quickly raised over $5 million to lead the first U.S.-based clinical trial for niclosamide as a COVID-19 treatment. Investors in ANA's seed round include former president of Y Combinator Sam Altman; Atomic fund founder Jack Abraham; Gmail creator and Y Combinator partner Paul Buchheit; Randi Zuckerberg's On Air Investments; Refactor Capital; a Palo Alto based early stage VC, SV Tech Ventures; Incite.org and Nest co-founder Matt Rogers and Incite.org co-founder, Swati Mylavarapu; Ron Conway's SV Angel; SOSV; and Neal Khosla co-founder of the health care start-up Curai.

"At Refactor Capital, we invest in health startups that creatively disrupt the status quo with visions for building great businesses that solve massive problems," said Zal Bilimoria, founding partner of Refactor Capital. "We couldn't think of a bigger problem to address right now than COVID-19, and we're excited to see ANA Therapeutics bring their niclosamide treatment to patients." 

For more information, visit: https://anatherapeutics.com/

ABOUT ANA THERAPEUTICS:

ANA Therapeutics, is a Silicon Valley-based biotech start-up working to develop niclosamide as a safe, widely accessible antiviral treatment for patients with COVID-19. A low-cost, scalable, and well tolerated compound, niclosamide has the potential to be a needed treatment to help individuals who contract the novel coronavirus to beat it. For more information, please visit https://anatherapeutics.com/.

MEDIA CONTACT:
Liz Squire
[email protected]
202-617-4662

SOURCE ANA Therapeutics

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http://www.anatherapeutics.com