Baudax Bio has reported positive top-line data from a Phase II clinical trial of BX1000 for the treatment of neuromuscular blockade (NMB) in patients undergoing elective surgery.
The active-controlled, double-blind, randomised study enrolled a total of 81 patients who were divided into four treatment groups.
One patient discontinued early and did not receive the study drug. However, the remaining 80 patients underwent treatment.
Three treatment groups of 20 each received three different doses of BX1000 against one group of 19 with a standard dose of 0.6mg/kg rocuronium. One subject in the rocuronium cohort experienced a delay in intubating condition assessment.
Using total intravenous anaesthesia, the elective surgery has been carried out in 80 adult patients with NMB.
The proportion of patients meeting criteria for Good or Excellent intubating conditions using a standardised scale was the primary endpoint of the study.
All patients in three BX1000 treatment group met the primary endpoint of Good or Excellent intubating conditions at 60 seconds.
The study also evaluated for the safety and tolerability of BX1000 and rocuronium in this patient population.
The company will follow up with the treated groups at 28 days after surgery and collect additional analyses of neuromuscular blockade data in the coming weeks.
Baudax Bio president and CEO Gerri Henwood said: “We believe these results demonstrate that BX1000 at the highest dose compares favourably to rocuronium, and when combined with our reversal agent BX3000, may provide improved control of neuromuscular paralysis for surgical patients.
“We look forward to discussing the results in greater detail with our Key Opinion Leaders today, and to advancing BX1000 and our NMB program to the next phase of development.”
The company plans to submit a new drug application near the year end of 2025, as part of continuing the development programme of BX 1000.