- The stock price of Atea Pharmaceuticals Inc (NASDAQ: AVIR) fell by over 65% today. This is why it happened.
The stock price of Atea Pharmaceuticals Inc (NASDAQ: AVIR) – a clinical-stage biopharmaceutical company – fell by over 65% today. Investors responded negatively to Atea Pharmaceuticals reporting that the global Phase 2 MOONSONG trial evaluating AT-527 in the outpatient setting did not meet the primary endpoint of reduction from baseline in the amount of SARS-CoV-2 virus in patients with mild or moderate COVID-19 compared to placebo in the overall study population, of which approximately two-thirds of patients were low-risk with mild symptoms.
But in high-risk patients with underlying health conditions, a reduction of viral load of approximately 0.5 log10 at Day 7 was observed at 550 mg (prespecified subgroup analysis) and 1,100 mg BID (exploratory subgroup analysis) compared with placebo.
Based on the MOONSONG topline and additional recent results for AT-527 as well as the evolving COVID-19 environment, Atea (together with Roche) are assessing potential modifications to the global Phase 3 MORNINGSKY trial including the trial’s primary endpoint and patient population. And as a result, they now anticipate Phase 3 MORNINGSKY data in the second half of 2022.
Atea and Roche are jointly developing AT-527 as an oral direct-acting antiviral (DAA) for the treatment of COVID-19. And its unique mechanism of action – with dual targets including chain termination (RdRp) and NiRAN inhibition – has the potential for creating a high barrier to resistance with broad antiviral coverage to different variants of SARS-CoV-2. Atea has completed a comprehensive nonclinical program to characterize the safety profile of AT-527. The results from these nonclinical studies demonstrate that AT-527 is non-mutagenic and has no effects on fertility and reproduction.
“The primary endpoint was not achieved in the overall study population in patients with mild or moderate COVID-19, however, MOONSONG topline data suggest that AT-527 has antiviral activity in high-risk patients with underlying health conditions as we previously reported in the Phase 2 hospitalized study. Based on these and other AT-527 data, we with our partner Roche, are assessing potential modifications to the Phase 3 MORNINGSKY protocol that may likely lead to improved clinical outcomes. 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, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals
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