A pill developed by two drugmakers failed to help COVID-19 patients with mild or moderate symptoms, one of the companies announced Tuesday.
Atea Pharmaceuticals and Roche tested their experimental treatment in a Phase 2 trial in outpatient settings, or non-hospitalized patients.
The study failed to meet the primary endpoint, which was a reduction in the amount of SARS-CoV-2 virus in patients with mild or moderate COVID-19 when compared to placebo.
SARS-CoV-2 is another name for the CCP (Chinese Communist Party) virus, which causes COVID-19.
The pill, known as AT-527, did reduce the viral load in high-risk patients with underlying health conditions, Atea said. AT-527 is an oral direct-acting antiviral that’s designed to stop the CCP virus from replicating by interfering with viral RNA polymerase.
The companies are now looking at modifying a phase 3 trial for the pill, including changing its primary endpoint and patient population. As a result, data from that study is not expected until the second half of 2022.
“We remain committed to our goal of developing and delivering AT-527 as an oral antiviral that will address treatment needs as COVID-19 continues to evolve,” Jean-Pierre Sommadossi, CEO and founder of Atea, said in a statement.
The new timeline puts the companies well behind Merck and Pfizer, which have both created pills for use against COVID-19.
Merck announced earlier this month that its pill showed positive results against non-hospitalized patients and on Oct. 11 sought emergency use authorization from the Food and Drug Administration (FDA).
The agency’s drug advisory panel is set to meet to discuss the application on Nov. 30.
“We believe that, in this instance, a public discussion of these data with the agency’s advisory committee will help ensure clear understanding of the scientific data and information that the FDA is evaluating to make a decision about whether to authorize this treatment for emergency use,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
That means authorization will come in December at the earliest for the drug, which some experts say could lead to the development of cancer because the pill works by causing genetic mutations in the virus itself.
Pfizer, meanwhile, earlier this year launched multiple Phase 2/3 trials analyzing the efficacy started of its antiviral on Sept. 1, including one exploring whether it helps in adults who show symptoms from COVID-19 but are not at increased risk of progressing to severe illness.
Pfizer’s pill is a protease inhibitor. It is meant to block the activity of the main protease enzyme that the CCP virus needs to replicate. The pill is being administered along with a low dose of ritonavir, an antiretroviral protease inhibitor.
