MALVERN, PA — Baudax Bio, Inc. (Nasdaq: BXRX), a pharmaceutical company, announced additional results from its Phase 2 clinical trial of BX1000 for neuromuscular blockade (NMB) in patients undergoing elective surgery. Additional analyses of electromyography (EMG) of neuromuscular blockade confirmed earlier conclusions that BX1000 at the highest dose compares favorably to rocuronium.
The BX1000 Phase 2 surgery trial was 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 completed clinical trial of 80 adult patients who had 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. All patients, across regimens, met the primary efficacy criteria. Additionally, the clinical trial evaluated the safety and tolerability profile of BX1000 and rocuronium in this patient population.
The additional EMG data showed a clear dose response for BX1000 on maximum T1 suppression, with comparable results for the 1.5x ED95 dose of BX1000 and the 2X ED95 dose of rocuronium. An equivalent “time to 80% NMB” was also observed between the highest dose level for BX1000 (0.35 mg/kg) and rocuronium (0.66 mg/kg). Recovery measures showed equivalent time for “full recovery” *for the highest dose of BX1000 (0.35 mg/kg) and rocuronium (0.60 mg/kg), but with tighter, thus more predictable, margins for BX1000.
“We believe these results further support the conclusions drawn from the clinical outcome data we announced in April, which demonstrated that BX1000 at the highest dose, compares favorably to rocuronium, and when combined with our reversal agent BX3000, we believe the regimen may provide improved control of neuromuscular paralysis for surgical patients,” said Stewart Mc Callum, MD, Chief Medical Officer of Baudax Bio. “We intend to discuss these results with our investigators and advisors, and to advance BX1000, which may represent the first innovation in NMB in decades.”
“The options currently available to anesthesiologists do not provide for ideal control of neuromuscular paralysis in certain situations, and the availability of effective short and long acting NMB agents together with a fast-acting reversal agent would be a game changer,” said Dr. Todd M. Bertoch, Chief Executive Officer of JBR Clinical Research, who was an Investigator for this trial. Dr. Bertoch also said, “I believe that if BX1000 is at least as effective as rocuronium, and you can reverse this drug successfully, you have a winner. In addition, I am most excited for the possibility of having a single reversal agent (BX3000) that could act on both the short acting drug (BX2000) and the longer acting drug (BX1000) because that cost-competitive family of agents would let you tailor to almost every anesthetic situation and I believe you wouldn’t need anything else at that point.”
A replay of the virtual key opinion leader event Innovation in Anesthesia: BX1000 for Neuromuscular Blockade (NMB) is available here.
*(Full recovery =TOF recovery to 0.9)
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