The second preplanned interim analysis of Baudax Bio, Inc.’s phase 2 trial of BX1000 for neuromuscular blockade (NMB) in patients undergoing elective surgery showed promising results. Baudax Bio, Inc. is a pharmaceutical company that specialises in developing novel products for hospitals and related settings. In a planned trial including 80 adult patients undergoing elective surgery under complete intravenous anaesthesia, the BX1000 phase 2 surgical trial will compare three different doses of BX1000 to a standard dose of 0.6 mg/kg rocuronium. It is a randomised, double-blind, active-controlled clinical trial. The percentage of patients who, according to a defined scale, satisfy the requirements for Good or Excellent intubating conditions is the primary efficacy outcome. Also, in this patient population, the clinical research is assessing the safety and tolerability profile of BX1000 and rocuronium.
In four cohorts with a minimum of 10 evaluable patients each, the second preplanned interim analysis assessed the intubating conditions in 41 patients. Findings revealed that at 60 seconds, all 41 participants had been observed to have met the requirements for Good or Excellent intubating conditions. 40 of the participants were actually intubated at 60 seconds, and one subject at 90 seconds. One patient reported a treatment-emergent adverse event that was determined to be probably related to research treatment, and study treatments were generally well tolerated with no occurrence of severe or serious adverse events. The decision to discontinue any of the four trial groups or to change the anticipated study enrollment number was not made as a result of this blinded interim analysis.
“With data from 50% of the total planned enrollment for this trial, these results give us confidence that BX1000, in combination 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. This data set is significant since it contains participants from a recently activated second study site and offers a preliminary indication that the findings can be repeated in a more extensive clinical setting. We anticipate wrapping up the trial’s enrollment soon and releasing the top-line findings in late April or early May.
Two novel NMBs, BX1000, an intermediate duration, clinical stage blocking agent, and BX2000, an ultra-short duration, clinical stage blocking agent, both of which are held exclusively by Baudax Bio, as well as a proprietary chemical reversal agent, BX3000, which is currently undergoing nonclinical studies in preparation for an IND filing in 2023. A special reversal agent called BX3000 quickly reverses BX1000 and BX2000. The three agents are all Cornell University licenced. We anticipate that when combined with BX 3000, these medicines will enable very quick induction of neuromuscular blockade for surgical contexts, predicted offset of blockade following administration, and accelerated reversal of the neuromuscular blockade. With less time spent in operating rooms or post-acute care settings, these novel agents have the potential to significantly shorten the time it takes for blocking to begin and for blockade to be reversed. This could have positive clinical and financial implications for hospitals and ambulatory surgical centres as well as significant time-related cost savings.
A pharmaceutical company called Baudax Bio specialises on cutting-edge products for healthcare facilities and similar settings. The company has a pipeline of cutting-edge pharmaceutical assets, including two novel neuromuscular blocking (NMBs) agents that are in the clinical stage, one of which is undergoing a phase II clinical trial and another is undergoing a dose escalation phase I clinical trial, as well as a proprietary chemical reversal agent that is exclusive to these NMBs and is presently undergoing nonclinical and manufacturing studies in preparation for an anticipated IND filing in the summer of 2023.
