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
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). Recovery measures showed equivalent time for “full recovery” *for the highest dose of BX1000 (0.35 mg/kg) and rocuronium (0.60 mg/kg), but with tighter, thus more predictable, margins for BX1000.
“We believe 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, and when combined with our reversal agent BX3000, we believe the regimen may provide improved control of neuromuscular paralysis for surgical patients,” said Stewart Mc Callum, MD, Chief Medical Officer of Baudax Bio. “We intend to discuss these results with our investigators and advisors, and to advance BX1000, which may represent the first innovation in NMB in decades.”
“The options currently available to anesthesiologists do not provide for ideal control of neuromuscular paralysis in certain situations, and the availability of effective short and long acting NMB agents together with a fast-acting reversal agent would be a game changer,” said Dr. Todd M. Bertoch, Chief Executive Officer of JBR Clinical Research, who was an Investigator for this trial. Dr. Bertoch also said, “I believe that if BX1000 is at least as effective as rocuronium, and you can reverse this drug successfully, you have a winner. In addition, I am most excited for the possibility of having a single reversal agent (BX3000) that could act on both the short acting drug (BX2000) and the longer acting drug (BX1000) because that cost-competitive family of agents would let you tailor to almost every anesthetic situation and I believe you wouldn’t need anything else at that point.”
A replay of the virtual key opinion leader event Innovation in Anesthesia: BX1000 for Neuromuscular Blockade (NMB) is available here.
*(Full recovery =TOF recovery to 0.9)
About Baudax Bio’s Neuromuscular Blocking and Reversal Agents (NMB)
Baudax Bio holds exclusive global rights to two novel NMB, BX1000, an intermediate duration, clinical stage blocking agent, and BX2000, an ultra-short duration, clinical stage blocking agent, as well as a proprietary chemical reversal agent, BX3000, undergoing nonclinical studies intended to support an investigational new drug (IND) submission in 2023. BX3000 is a specific reversal agent that may rapidly reverse BX1000 and BX2000. All three agents are licensed from Cornell University. We believe these agents will allow for a rapid induction of neuromuscular blockade for surgical settings, a predictable offset of blockade after administration, enhanced by rapid reversal of the neuromuscular blockade when BX3000 is used with the NMB agent. These novel agents have the potential to meaningfully reduce the time to onset of blocking and of reversal of blockade, reducing overall time in operating rooms or post-acute care settings, resulting in potential clinical and cost advantages, as well as time-related valuable cost savings for hospitals and ambulatory surgical centers.
About Baudax Bio
Baudax Bio is a pharmaceutical company focused on innovative products for acute care and related settings. The Company has a pipeline of innovative pharmaceutical assets including two clinical-stage, novel neuromuscular blocking (NMBs) agents, one undergoing a Phase II clinical trial and an additional unique NMB undergoing a dose escalation Phase I clinical trial, as well as a proprietary chemical reversal agent specific to these NMBs, which is currently undergoing nonclinical and manufacturing studies to prepare for an expected IND filing in the summer of 2023. For more information, please visit www.baudaxbio.com.
Forward Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements, including statements relating to the clinical development of Baudax Bio’s product candidates, reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend” and “expect” and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication of this press release and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio’s performance to differ materially from those expressed in, or implied by, these forward-looking statements. These risks and uncertainties include, among other things, risks related to market, economic and other conditions, the ongoing economic and social consequences of the COVID-19 pandemic, Baudax Bio’s ability to advance its current product candidate pipeline through pre-clinical studies and clinical trials, that interim results may not be indicative of final results in clinical trials, that earlier-stage trials may not be indicative of later-stage trials, the approvability of product candidates, Baudax Bio’s ability to raise future financing for continued development of its product candidates such as BX1000, BX2000 and BX3000, Baudax Bio’s ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio’s ability to comply with the financial and other covenants under its credit facility, Baudax Bio’s ability to manage costs and execute on its operational and budget plans, Baudax Bio’s ability to achieve its financial goals; Baudax Bio’s ability to maintain listing on the Nasdaq Capital Market; and Baudax Bio’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio’s business and future results included in Baudax Bio’s filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.
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Investor Relations Contact:
Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com
