SRNE - Sorrento wins FDA clearance to start mid-stage trial for RTX in osteoarthritis

yodiyim/iStock via Getty Images The FDA has given the go-ahead to Sorrento Therapeutics ([[SRNE]] -2.0%) to start a Phase 2 clinical study of RTX in the treatment of moderate-to-severe osteoarthritis of the knee pain ((OAK)), the company announced today. The multi-center, double-blind, placebo- and active-controlled study will be designed to evaluate the efficacy and safety of RTX across several dose groups. The company has added an active comparator (injectable corticosteroid) to the trial protocol citing the durability of pain relief shown by RTX so far. “Superiority data potentially generated by RTX against a widely used approved drug could be supportive for accelerated international registrations (Europe) and is required for pricing purposes in Europe,” Sorrento said in the statement.

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Sorrento wins FDA clearance to start mid-stage trial for RTX in osteoarthritis