- The FDA has signed off Sorrento Therapeutics Inc's SRNE Phase 2 study of Resiniferatoxin (RTX) for moderate-to-severe osteoarthritis of the knee pain (OAK).
- The Phase 2 trial, a multi-center, double-blind, placebo- and active-controlled study, will assess the efficacy and safety of several dose groups of RTX to manage pain in patients.
- Sorrento has decided to include an active comparator (injectable corticosteroid) in the current trial protocol.
- This Phase 2 study follows the analysis of the significant observations from the Phase 1b trial results.
- Phase 1b data demonstrated RTX safety for a single intra-articular administration without dose-limiting toxicity at any doses tested up to 30 ug.
- Phase 1b data demonstrated significant efficacy supporting RTX as an ideal candidate for long-term control of refractory OA pain: effective pain relief observed in patients with advanced OA disease and sustained pain relief last beyond six months.
- Price Action: SRNE shares are down 0.11% at $9.51 during the premarket session on the last check Wednesday.
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