SRNEQ) has recently released positive topline results from their pivotal Phase 3 study of Ovydso (Olgotrelvir, STI-1558), an oral Mpro inhibitor, for the treatment of mild or moderate symptomatic adults infected with SARS-CoV-2, or COVID-19. The study, which included 1,212 patients enrolled in China between February 2023 and June 2023, showed significant improvements in recovery time and viral RNA load reduction.\n\nThe primary endpoint of the study was the time to sustained recovery of 11 COVID-19 symptoms, and the key secondary endpoint was the viral RNA copy load reduction at Day 4 (after three-day treatment). Ovydso significantly shortened the clinical recovery time of 11 COVID-19 related symptoms by 2.4 days (8.6 days vs 11.0 days, HR 1.2995%CI, P=0.0001) and reduced the viral RNA load at Day 4 by -0.80 log10 (p1.0% with higher incidence in the Ovydso group than in the placebo group. No metallic taste was reported in the Ovydso group, and very few serious AEs were reported, which were not related to the drug.\n\nThe company has initiated communications with the China Health Authority (National Medical Products Administration, or NMPA) for a submission of a new drug application (NDA) and expedited review of the application based on the Phase 3 trial results. They also plan to open dialogue with other regulatory agencies around the world to discuss potential paths to approval.\n\nIn a Sorrento Therapeutics, incorporated has announced positive topline results from their pivotal Phase 3 study of Ovydso (Olgotrelvir, STI-1558), an oral Mpro inhibitor, in mild or moderate symptomatic adults infected with SARS-CoV-2, or COVID-19.’
‘ Sorrento Therapeutics Announces Positive Results from Phase 3 Study of Ovydso for COVID-19 Treatment\n\nSorrento Therapeutics (OTC: SRNEQ) has recently released positive topline results from their pivotal Phase 3 study of Ovydso (Olgotrelvir, STI-1558), an oral Mpro inhibitor, for the treatment of mild or moderate symptomatic adults infected with SARS-CoV-2, or COVID-19. The study, which included 1,212 patients enrolled in China between February 2023 and June 2023, showed significant improvements in recovery time and viral RNA load reduction.\n\nThe primary endpoint of the study was the time to sustained recovery of 11 COVID-19 symptoms, and the key secondary endpoint was the viral RNA copy load reduction at Day 4 (after three-day treatment). Ovydso significantly shortened the clinical recovery time of 11 COVID-19 related symptoms by 2.4 days (8.6 days vs 11.0 days, HR 1.2995%CI, P=0.0001) and reduced the viral RNA load at Day 4 by -0.80 log10 (p<0.0001) compared with the placebo group.\n\nThe study was conducted in an out-patient setting, with all patients receiving 600 mg BID of Ovydso for 5 days as a standalone treatment or placebo. The results of subgroup analyses were consistent with the overall results, with Ovydso showing improved recovery time and reduced viral RNA load in patients with risk factors for severe COVID-19.\n\nMost adverse events (AEs) reported were mild and balanced between the Ovydso group and the placebo group. Nausea (1.5% vs 0.2%) and skin rash (3.3% vs 0.3%) were the only two AEs that occurred with >1.0% with higher incidence in the Ovydso group than in the placebo group. No metallic taste was reported in the Ovydso group, and very few serious AEs were reported, which were not related to the drug.\n\nThe company has initiated communications with the China Health Authority (National Medical Products Administration, or NMPA) for a submission of a new drug application (NDA) and expedited review of the application based on the Phase 3 trial results. They also plan to open dialogue with other regulatory agencies around the world to discuss potential paths to approval.\n\nIn a Sorrento Therapeutics, incorporated has announced positive topline results from their pivotal Phase 3 study of Ovydso (Olgotrelvir, STI-1558), an oral Mpro inhibitor, in mild or moderate symptomatic adults infected with SARS-CoV-2, or COVID-19.’$SRNEQ2023-12-22T12:33:34.969Z
