Baudax Bio initiates Phase II trial evaluating BX1000

Baudax Bio announced the initiation of a clinical study evaluating the safety, tolerability profile, and intubation conditions of BX1000 for neuromuscular blockade in patients undergoing elective surgery. This randomized, double-blind clinical trial will study BX1000 in approximately 80 adult patients who undergo elective surgery utilizing total intravenous anesthesia in an outpatient setting. Patients will undergo elective surgery with an intravenous line for anesthesia and study drug administration. Once anesthetized, neuromuscular monitoring will be initiated via electromyography, and approximately 3-5 minutes after induction of anesthesia, the randomized NMB treatment will be administered as an IV bolus. Following successful tracheal intubation, patients will proceed to undergo their elective surgical procedures according to the standard practice of the investigator or surgical unit. "The initiation of this Phase II clinical study in patients undergoing elective surgery is an important step for the overall NMB program, and we look forward to data on BX1000’s safety, tolerability, and neuromuscular blocking profile," said Gerri Henwood, Baudax Bio’s President and Chief Executive Officer. "We believe that BX1000, in combination with BX3000, may permit precise control of the time patients are under neuromuscular paralysis. This could be significantly impactful for patients, surgeons, and anesthesiologists by enhancing safety, and possibly saving time and reducing costs related to delayed recovery from neuromuscular paralysis following surgical procedures. To date, no serious adverse events have been reported in the first group of patients enrolled and efficacy parameters have been recorded. We look forward to announcing the completion of the pre-planned first interim analysis of the BX1000 Phase 2 surgery trial early in 2023, with a target of completing full study enrollment by the end of March, 2023."