Pardes Biosciences’ pomotrelvir does not meet primary endpoint

Pardes Biosciences reported topline results from its Phase 2 clinical trial evaluating pomotrelvir for the treatment of mild-to-moderate COVID-19 in test-positive, symptomatic, otherwise healthy, vaccinated adults without risk factors for developing severe disease. Pomotrelvir did not meet the primary endpoint measured by the proportion of participants below the limit of detection for infectious SARS-CoV-2 on day 3 of treatment with pomotrelvir versus placebo. Otherwise healthy, vaccinated adults without risk factors for progression to severe disease experienced rapid clearance of SARS-CoV-2 virus and evidence of rapid alleviation of targeted and key COVID-19 symptoms independent of treatment arm. As a result of these data, the Company has decided to suspend further development of pomotrelvir and explore a range of strategic alternatives."We continue to believe in the need for new oral antivirals for COVID-19, and the importance of continued investment in next generation therapeutics that will be needed to help prevent the next pandemic. However, these unexpected results have forced us to make the difficult decision to suspend further development of pomotrelvir and pursue alternative strategic opportunities for the company," said Thomas Wiggans, Chief Executive Officer and Chair of Pardes Biosciences.Topline Phase 2 Results: Pomotrelvir did not achieve the primary endpoint as measured by proportion of participants below the limit of detection for infectious SARS-CoV-2 on day 3 by infectious virus assay with 70% reaching undetectable levels in the pomotrelvir treated group versus 63% in the placebo group. Pomotrelvir did not demonstrate meaningful improvement over placebo in reduction from baseline of SARS-CoV-2 infectious virus titer by IVA or in the reduction from baseline or proportion achieving undetectable viral load by quantitative reverse transcriptase polymerase chain reaction measured from mid-turbinate swabs. There were no deaths and no participants experienced progression to severe COVID-19. Overall, baseline levels of SARS-CoV-2 infectious virus and viral load were lower, clearance of infectious virus was more rapid, and the speed of COVID-19 symptom improvement was faster than anticipated when the study was designed.