Tuesday, March 28, 2023
Baudax Bio, Inc., a pharmaceutical company focused on innovative products for hospital and related settings, today announced positive results from the second preplanned interim analysis of its Phase 2 trial of BX1000 for neuromuscular blockade (NMB) in patients undergoing elective surgery.
The BX1000 Phase 2 surgery trial is a randomized, double-blind, active-controlled clinical trial comparing three different 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 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, with each cohort having a minimum of 10 evaluable patients. 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 1 subject at 90 seconds. Study treatments were generally well tolerated, with no occurrence of severe or serious adverse events, and one patient experienced a treatment-emergent adverse event that was determined to be possibly related to study treatment. This blinded interim analysis did not result in the decision to drop any of the four study groups nor any decision to adjust planned study enrollment number.
“With data from 50% of the planned total enrollment for this trial, these results provide us with confidence that BX1000, combined with our reversal agent BX3000, may provide more precise control of neuromuscular paralysis for surgical patients and have the potential to improve on total time of blockade and reversal compared to available agents,” said Gerri Henwood, President and Chief Executive Officer of Baudax Bio. “Importantly, this data set includes subjects from a recently activated second clinical site, and provides an early indication that these results can be replicated in broader clinical use. We anticipate completing enrollment in this trial soon, and announcing top line results in late April or early May.”