DewDiligence
1 month ago
AVIR completes enrollment of phase-3 COVID trial—cancels interim analyses:
https://www.globenewswire.com/news-release/2024/03/27/2853010/0/en/Atea-Pharmaceuticals-Completes-Patient-Enrollment-in-Global-Phase-3-SUNRISE-3-Trial-Evaluating-Oral-Antiviral-Bemnifosbuvir-for-COVID-19-in-High-Risk-Patients.html Atea Pharmaceuticals…today announced that the company has completed enrollment of the global Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir, an oral nucleotide polymerase inhibitor, or placebo for the treatment of COVID-19. Over 2,200 patients were randomized into the supportive care monotherapy cohort… The primary endpoint of the trial is all-cause hospitalization or death through Day 29 post-treatment in the bemnifosbuvir supportive care monotherapy cohort of high-risk patients. The two planned interim analyses have been canceled: “Since full enrollment was achieved ahead of the two planned interim analyses for safety and futility by the Data Safety Monitoring Board (DSMB), the analyses are no longer relevant, and in agreement with the DSMB, we will proceed to the full analysis of the trial. We look forward to reporting SUNRISE-3 results in the second half of 2024…
crudeoil24
3 years ago
Atea Pharmaceuticals to Present at Guggenheim 2nd Annual Vaccines & Infectious Day Conference
7:00 am ET September 29, 2021 (Globe Newswire) Print
Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today announced that Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea together with other members of the Atea management team, will participate in a fireside chat at the Guggenheim 2nd Annual Vaccines & Infectious Day Conference on Tuesday, October 5, 2021 at 9:30 a.m. ET.
A live webcast of the presentation will be available here and on the Company's website at www.ateapharma.com. A replay of the webcast will be available for 90 days following the presentation.
About Atea Pharmaceuticals
Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing oral therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company's deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally-available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com.
Contacts
Jonae Barnes
SVP, Investor Relations and Corporate Communications
617-818-2985
Barnes.jonae@ateapharma.com
crudeoil24
3 years ago
AVIR up 30% @ 45.00 > As Barron's reported in a magazine feature earlier this month , the pills have the potential to play an enormous role as the world adapts to an endemic threat from Covid-19. Even if the antivirals from Merck, Pfizer, the biotech Atea Pharmaceuticals (AVIR), and others, are only moderately effective, they are likely to be in enormous demand globally as patients and governments seek to blunt the human toll of the virus.
Paullee
3 years ago
Josh Nathan-Kazis
The mid-cap biotech Atea Pharmaceuticals is a frontrunner in the race to develop a Covid-19 antiviral, and its share price could double if an ongoing trial returns positive data, according to a note out early Thursday from SVB Leerink .
Atea (ticker: AVIR) is one of a number of companies developing Covid-19 antivirals, amid an emerging consensus that the virus that causes Covid-19 will remain a global health challenge for the long-term.
Big pharma giants Merck (MRK) and Pfizer (PFE) both are developing their own Covid-19 antiviral pills, but SVB Leerink analyst Roanna Ruiz writes in her Thursday note that the Covid-19 therapeutic market is "not a zero-sum game."
Atea's pill, known as AT-527, works differently from the Pfizer and Merck antivirals in development. The company is partnering with Roche (RHHBY) on development of the drug, which produced positive data in a Phase 2 trial. It is currently in a Phase 3 trial in non-hospitalized patients.
The trial is expected to produce data in the second half of this year. If those results are positive, Ruiz writes, they would be enough for the company to go to the U.S. Food and Drug Administration for emergency authorization.
If the FDA approves the drug, Ruiz projects that it could hit $2.3 billion in peak annual sales.
Ruiz initiated her coverage of the stock with an Outperform rating on Thursday and a $60 target price. The stock closed Wednesday at $27.70 and was up 0.2% on Thursday. Shares are down 33.6% this year amid a broader pullback among small and midcap biotech names.
In addition to the Phase 3 study of AT-527 in non-hospitalized patients with mild to moderate Covid-19, which will read out in the second half of this year, the company is running other trials of the drug, including one set to start this year that will test the drug as a prophylaxis. Ruiz estimates that the company could submit the drug for FDA authorization in late 2021 or early 2022.
"AT-527 could be one of the first approved oral antiviral therapies against Covid-19 and [key opinion leaders] are desperate for more convenient options," Ruiz wrote.
Amid the intense focus on Covid-19 vaccines, the effort to develop Covid-19 therapeutics has received substantially less attention. While a number of Covid-19 therapeutics do exist, all of the authorized options are either relatively ineffective or relatively inconvenient. The best available treatments, monoclonal antibody therapies from companies like Regeneron Pharmaceuticals (REGN), require patients to go to clinics to receive infusions.
In her note, Ruiz notes that Merck's molnupiravir may be ahead of AT-527 in terms of timing. Still, she writes that the market for a Covid-19 oral antiviral is big enough for more than one drug.
"We believe investors are watching molnupiravir and AT-527 closely, as both are in Phase 3 trials to treat outpatient COVID19; however, we do not think that this is a zero-sum game, and we think both orals would be used broadly in practice," Ruiz writes.
She says that Pfizer's oral antiviral, known as PF-00835231, may be a bit behind molnupiravir and AT-527, but is still a key competitor. "Despite it being slightly behind Merck/Atea, Pfizer's oral protease inhibitor could become a viable outpatient treatment option for COVID-19 if its antiviral efficacy is reiterated in the recently initiated larger Phase 2/3 trial," she writes.
Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com