- Baudax Bio Inc BXRX announced results from the second preplanned interim analysis of its Phase 2 trial of BX1000 for neuromuscular blockade (NMB) in patients undergoing elective surgery.
- The company announced the outcome of its first interim analysis in a Phase 2 trial of BX1000 in patients undergoing elective surgery in January.
- All 20 patients were observed to have met the criteria for Good or Excellent intubating conditions at 60 seconds.
- The BX1000 Phase 2 surgery trial is a randomized, double-blind, active-controlled clinical trial comparing three doses of BX1000 to a standard dose of 0.6mg/kg rocuronium in a planned trial of 80 adult patients undergoing elective surgery utilizing total intravenous anesthesia.
- The primary efficacy endpoint is the proportion of patients meeting the criteria for Good or Excellent intubating conditions using a standardized scale.
- Additionally, the clinical trial is evaluating the safety and tolerability profile of BX1000 and rocuronium in this patient population.
- The second preplanned interim analysis evaluated the intubating conditions in 41 patients in four cohorts.
- Results showed that all 41 subjects were observed to have met the criteria for Good or Excellent intubating conditions at 60 seconds. Actual intubation of 40 of the subjects occurred at 60 seconds, and one subject at 90 seconds.
- Study treatments were generally well tolerated, with no severe or serious adverse events.
- Topline data is expected in late April/early May.
- Price Action: BXRX shares are up 6.92% at $1.66 on the last check Monday.
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