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Atea Pharmaceuticals has received US Food and Drug Administration (FDA) clearance for the investigational new drug application (IND) of AT-527 for the treatment of Covid-19.
The approval will allow the company to assess the safety and efficacy of the drug in a Phase II clinical trial for adult patients hospitalised due to moderate Covid-19 and have one or more risk factors for poor outcomes.
A purine nucleotide prodrug, AT-527 is a selective, oral direct acting antiviral (DAA) that blocks the RNA polymerase enzyme, which is known to be important for the replication machinery of RNA viruses.
The drug candidate demonstrated antiviral activity in-vitro and in-vivo against the replication of various RNA viruses, including human coronaviruses and flaviviruses.
Atea Pharmaceuticals founder, chairman and CEO Jean-Pierre Sommadossi said: “Atea’s portfolio is focused on developing novel, best-in-class, potent DAA’s and we have shifted all of our immediate resources and our team’s deep expertise in virology and pharmacology to help address the unmet needs in the fight against the Covid-19 pandemic.
“An oral treatment for Covid-19 patients should prevent progression of the disease and may help lessen the burden on critical inpatient resources. Atea is moving rapidly, in concert with regulatory authorities, to determine if our oral DAA is a safe and effective therapeutic against Covid-19.”
The company has also secured $215m in a series D financing round led by Bain Capital Life Sciences. Existing stakeholders and new investors, such as RA Capital Management, Perceptive Advisors and Rock Springs Capital, participated in the round.
Proceeds will be used to support the clinical development of a potential Covid-19 treatment, as well as to advance the company’s pipeline of DAAs against different RNA viral infections.