Sorrento Therapeutics (NASDAQ:SRNE) announces that the Phase 1b study has generated positive data and met the day 84 goals set for the resiniferatoxin (RTX) program to advance the investigational drug product into Phase 3 clinical trials.
This study is to assess the safety and preliminary efficacy of intra-articular administration of resiniferatoxin or saline control (as placebo group) for the treatment of moderate to severe pain due to osteoarthritis of the knee.
45 patients were treated in Phase 1b trial to date. 37 patients received RTX and 8 patients received saline (pooled as placebo group).
Most adverse events were expected and included pain, hypertension and tachycardia. These events were moderate and resolved in less than a day.
At the time of update, 30 patients were assessed at day 84.
Further analysis comparing RTX to saline response highlights persistent effect beyond day 84.
Two dose levels will be further expanded to confirm the final dose for upcoming Phase 3 studies.
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