Baudax Bio revealed has additional results from a Phase II trial investigating its neuromuscular blockade (NMD) agent BX1000 in patients undergoing elective surgery demonstrating favourability to rocuronium. The company now plans to combine it with its pipeline reversal blocking agent.
Shares in the US-based company previously surged after the topline data reveal in April. After the additional data reveal today, shares opened at 7% higher than the previous day’s (June 6) close.
In the randomised, double-blind, active-controlled clinical trial (NCT05687253), 80 patients were divided into three BX1000 dose groups and one rocuronium group of standard dose 0.6 mg/kg. According to the entry on ClinicalTrials.gov, BX1000 doses were 0.15, 0.25, and 0.35 mg/kg administered intravenously. Rocuronium is a widely used intermediate-acting neuromuscular blocker.
All treated patients met the primary efficacy endpoint of the study – assessment of incubation conditions meeting Good or Excellent criteria according to a standardised scale. Baudax Bio also reported that additional data measured by electromyography (EMG) showed BX1000’s comparableness to rocuronium. The highest dose level of BX1000 had an equivalent time to 80% NMB and time for ‘full recovery’ to that of rocuronium. The results add to previous topline data released by the company in April showing evidence of dose-response across the three groups and positive primary endpoint meeting.
BX1000 is an intermediate duration, clinical-stage blocking agent. Its sister agent, BX2000, is an ultra-short duration, clinical-stage blocking agent. Baudax Bio holds exclusive global rights to both assets and is planning an investigational new drug (IND) application in 2023 for BX3000 – a reversal agent that may rapidly reverse BX1000 and BX2000. All three agents are licensed from Cornell University, New York.
The news comes after new guidelines published in January 2023 by the American Society of Anaesthesiologists (ASA) called for more careful and quantitative monitoring of neuromuscular blocking during general anaesthesia.
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“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,” said Dr Stewart McCallum, Chief Medical Officer of Baudax Bio.
“When combined with our reversal agent BX3000, we believe the regimen may provide improved control of neuromuscular paralysis for surgical patient.”