By T. Chakraborty, Ph.D. & Rajaneesh K. Gopinath, Ph.D.
On October 22nd, Atea Pharmaceuticals, Inc. announced that it had entered into an arrangement with Roche for the exclusive rights to research, develop and distribute their oral antiviral treatment for COVID-19 named AT-527, outside the USA. The agreement states that Atea Pharmaceuticals will receive an upfront cash payment of $350 million from Roche with the potential to receive further payments and royalties on previously agreed terms.
“Roche shares our passion for delivering innovative new medicines to address great unmet medical needs. The COVID-19 pandemic has highlighted the urgent need for a novel, oral antiviral to treat this highly infectious and often deadly virus. This collaboration with Roche enhances Atea’s efforts and underscores the potential for AT-527 to effectively address the COVID-19 crisis on a global scale,” said Jean-Pierre Sommadossi, Ph.D., Chief Executive Officer and Founder of Atea Pharmaceuticals.
“AT-527 is expected to be ideally suited to combat COVID-19 as it inhibits viral replication by interfering with viral RNA polymerase, a key component in the replication machinery of RNA viruses. Importantly, the manufacturing process for our small molecule direct-acting antiviral allows us to produce AT-527 quickly and at scale,” he added.
Launched in 2014, Boston-based Atea Pharmaceuticals focuses on researching, developing, and commercializing antiviral therapeutics essential in fighting viral infections globally. The company’s expertise lies in manipulating a key viral enzyme, RNA polymerase that is responsible for allowing pathogens to copy, survive, and spread. On October 9th, the company filed for an initial public offering to raise $100 million.
Its AT-527 has previously been studied as an oral treatment for Hepatitis C and has completed Phases 1 and 2 with good results. Due to the pandemic, the company decided to shift its focus and reorient itself to serve the country’s needs at the moment. In May, the company managed to raise $215 million in funding for their work related to COVID-19. This led to the initiation of a Phase 2 placebo-controlled trial that intends to recruit around 200 patients in the earlier stages of the disease. The study also looks to focus on patients aged between 45-80 years having a history of obesity, asthma, and have been hospitalized for moderate symptoms, among others. The company expects to have its initial results by December of this year or January 2021. If all goes well, Atea Pharmaceuticals plans to start a global Phase 3 trial in the first half of 2021.
“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,” said Sommadossi in May after the initial funding round. “An oral treatment for COVID-19 patients should prevent [the] 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 [directly acting antiviral] is a safe and effective therapeutic against COVID-19.”
AT-527 – A Potential First Oral Treatment for COVID-19
AT-527 is an investigational, oral, purine nucleotide prodrug which has demonstrated in vitro and in vivo antiviral activity against several enveloped single-stranded RNA viruses, including human flaviviruses and coronaviruses. Apart from being a potential oral treatment option for hospitalized patients, AT-527 could also be a potential first oral treatment option for COVID-19 patients that are not hospitalized.
“The ongoing complexities of COVID-19 require multiple lines of defense. By joining forces with Atea, we hope to offer an additional treatment option for hospitalized and non-hospitalized COVID-19 patients and provide important relief for hospital infrastructures during a global pandemic. In jointly developing and manufacturing AT-527 at scale, we seek to make this treatment option available to as many people around the world as we possibly can,” said Bill Anderson, Chief Executive Officer of Roche.
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