Sorrento Announces the Full Enrollment of the Pivotal Phase 3 Trial with Olgotrelvir (OVYDSOTM) (STI-1558), a Second Generation Oral Mpro Inhibitor, as a Standalone Treatment for COVID-19

• The Phase 3 study of Ovydso was initiated in China in February 2023 and enrolled and dosed 1,200 COVID-19 patients (1:1, active:placebo) at 25 sites in China.
• During the trial, Ovydso has maintained an excellent safety profile with no Grade 3 toxicities reported.
• We anticipate top line data in the third quarter of this year.
• If the trial meets its endpoints, we have agreements with the China Health Authority (National Medical Products Administration, or NMPA) for a fast review of the application based on this Phase 3 trial.
• Should the Phase 3 trial be successful, we plan to open dialogue with regulatory agencies around the world to discuss paths to approval.
  

SAN DIEGO, June 26, 2023 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (OTC: SRNEQ) announced today the full enrollment in a pivotal Phase 3 study of Sorrento’s oral M^pro inhibitor, Ovydso (STI-1558), in mild or moderate symptomatic adults infected with SARS-CoV-2, or COVID-19.

The Phase 3 study (MPR-COV-301CN) is entitled: “A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study Evaluating the Efficacy and Safety of STI-1558 in Adult Subjects With Mild or Moderate (COVID-19)”. The Phase 3 study has enrolled 1,200 patients with COVID-19. After communications with the NMPA, a consensus was reached on the primary endpoint and the key secondary endpoint, which are the time to recovery for 11 key COVID-19 symptoms and the viral RNA copy load reduction in comparison with the baseline, respectively. The study was conducted at 25 sites in China, led by Dr. Hongzhou Lu, Fellow of the American Society for Microbiology, Professor and Dean of Shenzhen Third Hospital and co-led by Dr. Ronmeng Jiang, Professor and Deputy Dean of Beijing DiTan Hospital.

As the dosing of the last patient is complete and due to the nature of the trial (5 days of treatment), Sorrento has been cleaning the database throughout the duration of the trial and expects to have the database fully cleaned and locked in August 2023. Sorrento anticipates top line data from the study in the third quarter of this year.

With the completion of enrollment for this trial, Sorrento has treated almost 1,450 volunteers and patients. Once the data is finalized, Sorrento plans to open discussions with regulatory authorities worldwide to discuss the path required for each particular authority for a full approval of Ovydso.

“We are pleased to see that Ovydso has enrolled quickly for a successful completion of enrollment for the phase 3 pivotal trial in China. We look forward to seeing the final data and to working closely with the NMPA during the review to evaluate this as a potential stand-alone treatment for COVID-19 patients as rapidly as possible,” stated Henry Ji, Ph.D., Chairman and CEO of Sorrento.