MALVERN, PA — Baudax Bio, Inc. (Nasdaq: BXRX) this week announced positive top-line results from its Phase 2 clinical trial of BX1000 for neuromuscular blockade (NMB) in patients undergoing elective surgery. Results of the study showed that BX1000 met the primary endpoint of readiness for intubation (evaluated as “Good” or “Excellent”) at all dose levels assessed. No severe adverse events were observed in any dose regimen.
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 clinical trial of 80 adult patients undergoing elective surgery utilizing total intravenous anesthesia. A total of 81 patients were randomized to the four treatment groups. One patient discontinued early and did not receive a study drug. A total of 80 patients were treated. Each BX1000 dose cohort had 20 evaluable patients and the rocuronium cohort had 19 evaluable patients (one subject in this arm experienced a delay in intubating condition assessment.) The primary efficacy endpoint of the study was the proportion of patients that met criteria for Good or Excellent intubating conditions using a standardized scale. Additionally, the clinical trial evaluated the safety and tolerability profile of BX1000 and rocuronium in this patient population.
Results showed that all patients in three BX1000 study cohorts were observed to have met the criteria for Good or Excellent intubating conditions at 60 seconds. There was evidence of a dose-response across the three doses of BX1000, and the degree of blockade for the highest dose group appears comparable to that of the “standard” dose of rocuronium (0.6 mg/kg) employed in the study. Study treatments were generally well tolerated, with no occurrence of severe or serious adverse events. The frequency and severity of adverse events was similar across all four dose groups, and no notable events were aggregated in any one dose group.
There will be further patient safety follow up at 28 days after surgery as well as additional analyses of neuromuscular blockade data in the coming weeks. The Company will be continuing the development program for BX 1000 with a target of submitting a New Drug Application (“NDA”) by approximately year-end 2025. The Company also remains committed to working and collaborating with regulators to advance development of its NMB product candidates, including BX1000, and its reversal agent product candidate.
“We believe these results demonstrate that BX1000 at the highest dose compares favorably to rocuronium, and when combined with our reversal agent BX3000, may provide improved control of neuromuscular paralysis for surgical patients,” said Gerri Henwood, President and Chief Executive Officer of Baudax Bio. “These very encouraging data indicate that BX1000 may represent the first innovation in NMBs in decades. 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.”
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