Tuesday, March 28, 2023
Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.
Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.
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All patients met Good or Excellent intubating conditions. In the 2nd interim pre-planned analyis released Monday, March 27th, 41 patients from 4 cohorts (at least 10 from each) met Good or Excellent intubating conditions, with 40 patients intubated at 60 seconds and 1 patient at 90 seconds. Treatments were generally well tolerated, and while there were no serious events, one patient experienced a treatment-emergent adverse event that could possibly be related to treatment. Based on the analysis, none of the four cohorts (3 different dose groups of BX1000, and a standard dose group of rocuronium) are expected to be dropped nor is the full 80-patient trial enrollment number expected to be adjusted.
Results similar to the 1st interim analysis. In late January, Baudax Bio released the 1st interim analysis that showed the 20 patients (5 patients from each of the four cohorts) met the criteria for Good or Excellent intubating conditions with no adverse events. As a reminder, the primary endpoints assess the time frame needed to reach intubation conditions (time frame is within 2 minutes of administration) and also assess, using a standardized scale (Poor, Good, Excellent), the proportion of patients meeting Good or Excellent conditions. Secondary endpoints assess the safety and tolerability profile of BX1000.
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