Sorrento Announces Phase 3 Trial Met Primary Endpoint and Key Secondary Endpoint in Mild or Moderate COVID-19 Adult Patients Treated with Ovydso (Olgotrelvir), an Oral Mpro Inhibitor as a Standalone Treatment for COVID-19

• In the phase 3 trial, a randomized double blind and placebo-controlled pivotal study, 1,212 mild or moderate COVID-19 patients were enrolled and treated with OVYDSO (Olgotrelvir) or placebo. The primary endpoint was time to sustained recovery of 11 COVID-19 related symptoms and the key secondary endpoint was the viral RNA copy load reduction.
• Ovydso significantly shortened clinical recovery time of 11 COVID-19 related symptoms by 2.4 days (8.6 days vs 11.0 days, HR 1.29/95%CI, P=0.0001) and reduced the viral RNA load at Day 4 (three days after treatment) by -0.80 log₁₀ (p<0.0001) compared with the placebo group.
• Most adverse events (AEs) were mild and balanced between Ovydso group and placebo group. Among AEs >1%, nausea (1.5% vs 0.2%) and skin rash (3.3% vs 0.3%) were more frequent in the Ovydso group than in the placebo group.
• We have 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.
• We also plan to open dialogue with other regulatory agencies around the world to discuss potential paths to approval.
  

SAN DIEGO, Sept. 12, 2023 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (OTC: SRNEQ, “Sorrento”) announced today positive topline results of a pivotal Phase 3 study of Sorrento’s oral M^pro inhibitor, Ovydso (Olgotrelvir, STI-1558), in mild or moderate symptomatic adults infected with SARS-CoV-2, or COVID-19, irrespective of risk factors for severe complications. Ovydso is an Oral M^pro Inhibitor as a standalone treatment for COVID-19 meaning it does not require co-administration with other agents. The Phase 3 study results met the primary endpoint of time to sustained recovery of 11 COVID-19 symptoms, as well as the key second endpoint of the viral RNA copy load reduction at Day 4 (after three-day treatment).

In this phase 3 trial, 1,212 patients were enrolled in China between February 2023 and June 2023, and 98.7% of the patients were vaccinated or previously infected with SARS-CoV-2. All patients were treated in an out-patient setting and received 600 mg BID of Ovydso for 5 days as a standalone treatment or placebo. The median time to sustained recovery of 11 COVID symptoms was 8.6 days in comparison with 11.0 days in the placebo group (HR 1.29/95% CI, p=0.0001). Ovydso also demonstrated profound antiviral activity in COVID-19 patients at Day 4 (three days after treatment), reducing the viral RNA copy load by -0.8 log₁₀ (p< 0.0001) compared with placebo group. Results of subgroup analyses were largely consistent with these overall results. In patients with risk factors for severe COVID-19, Ovydso improved recovery time by 2.3 days (7.6 days vs 9.9 days, HR 1.36/95% CI, p= 0.026) and reduced viral RNA copy load by -1.10 log₁₀ (p<0.0001) at Day 4, compared with the placebo group.