Baudax Bio Announces Additional, Positive Top-Line Results From Phase 2 Randomized Clinical Trial of BX1000
Secondary Efficacy Analyses, Including of Neuromuscular Blockade and Spontaneous Reversal, Support Earlier Reported Clinical Results with BX1000
Excerpt from the Press Release:
MALVERN, Pa., June 07, 2023 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (Nasdaq:BXRX) (the “Company”), a pharmaceutical company focused on innovative products for acute care and related settings, today 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).
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