Sorrento Therapeutics Inc (SRNE)

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Sorrento Therapeutics, Inc.
Mon, June 26, 2023 [img][/img]
(Maybe there still is a demand for Covi-19 treatment in other countries.)

"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.

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.