Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced that the company has completed enrollment of its latest Phase 2 clinical study of RTX for treating moderate-to-severe osteoarthritis of the knee pain (OAK). This Phase 2 study follows the analysis of the positive observations from the Phase 1b/2 trial results (NCT03542838) of RTX Day 84 patient data, for which Sorrento completed the one year following up of last patient visit in February 2021.
The phase 2 trial, a multi-center, double blind, placebo- and active-controlled study, assesses the efficacy and safety of several dose groups of RTX to manage pain in patients with moderate-to-severe osteoarthritis of the knee pain (OAK) (clinicaltrials.gov: NCT04885972). Given the durability of OAK pain relief response to RTX demonstrated in earlier phase 1/2 trials, Sorrento has decided to include an active comparator (injectable corticosteroid) in the current trial protocol. If superiority is demonstrated by RTX against this widely used approved drug, this could be supportive data for accelerated international registrations and would enable pricing discussions with regulatory authorities in Europe.
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