Baudax Bio Announces Clinical Program Update for Neuromuscular Blocking Agents BX-1000, BX-2000 … | Your money
BX-1000 Completes Dose Escalation Study; Was generally well tolerated and rapidly achieved muscle paralysis, as well as complete spontaneous recovery
BX-2000 and BX-3000 to enter clinical studies in 2022
MALVERN, Pa., Nov. 11, 2021 (GLOBE NEWSWIRE) – Baudax Bio, Inc. (NASDAQ: BXRX), a pharmaceutical company focused on the commercialization and development of innovative acute care products, today announced a update of its clinical program for its blocking agents (NMB), including the completion of a dose escalation study evaluating BX-1000 in healthy volunteers.
Baudax’s proprietary NMBs are BX-1000, an intermediate duration NMB, BX-2000, an ultra-short duration NMB, and BX-3000, a reversal agent that quickly reverses the effects of BX-1000. and the BX-2000. Used together, these agents allow very rapid induction of neuromuscular block in a surgical setting, followed by rapid reversal of neuromuscular block. We believe these new agents have the potential to significantly reduce recovery time from the procedure in operating rooms or post-acute care, resulting in valuable cost savings for hospitals and outpatient surgical centers.
âThe completion of this dose escalation study is an important milestone for the entire NMB program, and we look forward to finalizing the clinical study report and sharing the data with the Food and Drug Administration (FDA). from the United States, âsaid Stewart McCallum, Chief Medical Officer of Baudax Bio. âWe believe that the combination of BX-1000 or BX-2000 with the dedicated reversal agent, BX-3000, can allow precise control of the length of time patients are under neuromuscular palsy. This could have a significant impact for patients, surgeons and anesthesiologists by improving safety and controlling costs associated with delayed recovery from neuromuscular palsy following surgical procedures. We look forward to advancing our NMB and associate candidates in 2022. â
A total of 58 subjects participated in a dose escalation study evaluating BX-1000. Based on FDA guidelines and comments, the evaluation of BX-1000 was conducted in healthy volunteers who had previously undergone endotracheal intubation under general anesthesia. Following intubation, subjects received a single IV bolus dose of BX-1000 and were closely monitored for neuromuscular blockade and any changes in vital signs or the presence of adverse events.
BX-1000 dose escalations were continued until predefined effects were seen. Overall, BX-1000 was generally well tolerated over the dosage range tested. Muscle paralysis was quickly achieved with complete spontaneous recovery. Baudax is preparing the clinical study report for this dose escalation study and plans to submit it to the FDA early in the new year. Meanwhile, Baudax is finalizing its plans to move on to the next study in surgical patients which is expected to begin around mid-2022.
BX-2000, a single ultra-short-acting NMB, which has previously been studied in non-human primates and Baudax is currently conducting an additional toxicology study requested by the FDA, which began dosing this month. Baudax plans to submit the report of this toxicology study on BX-2000 to the FDA in the first quarter of 2022. Once the data has been evaluated by the FDA, the Company plans to initiate a dose escalation study in a timely manner in healthy volunteers. .
The BX-3000 was designed to induce the chemical cleavage of BX-1000 and BX-2000, resulting in the rapid inactivation of these molecules and thus rapidly reversing neuromuscular blockade. Baudax plans to launch the BX-3000 clinical program at the end of 2022.
About Baudax Bio Neuromuscular Blocking Agents (NMBAs)
Baudax owns the exclusive worldwide rights to two new NMBAs, BX-1000, an intermediate-acting clinical stage agent, and BX-2000, an ultra-short-lived preclinical stage agent, and a proprietary chemical reversal agent , the BX-3000, that is to say specific to, and quickly reverses, BX-1000 and BX-2000. All three agents were licensed by Cornell University in 2017. Used together, these agents allow very rapid induction of neuromuscular block for surgical settings, followed by rapid reversal of neuromuscular block. These new agents have the potential to significantly reduce recovery time from the procedure in operating rooms or post-acute care settings, resulting in valuable cost savings for hospitals and outpatient surgical centers.
About Baudax Bio
Baudax Bio is a pharmaceutical company focused on the commercialization and development of innovative products for acute care settings. ANJESO is the first and only COX-2 preferred nonsteroidal anti-inflammatory drug (NSAID) administered intravenously (IV) over 24 hours for the management of moderate to severe pain. In addition to ANJESO, as described in this press release, Baudax Bio has a pipeline of other innovative pharmaceutical active ingredients, in particular two new neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs. For more information, please visit www.baudaxbio.com.
This press release contains forward-looking statements that involve risks and uncertainties. These forward-looking statements reflect Baudax Bio’s expectations regarding its future performance and the opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate”, “believe”, “estimate”, “power”, “to come”, “plan”, “target”, “objective”, “intend” and ” expect âand similar expressions, with respect 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 at the date of publication on this website, including statements relating to the development of each of the BX-1000, BX-2000 and BX-3000, 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 or implied by these forward-looking statements. These risks and uncertainties include, among others, risks related to the ongoing economic and social consequences of the COVID-19 pandemic, the ability of Baudax Bio to advance its current product candidate portfolio through preclinical studies and ” clinical trials, the ability of Baudax Bio to increase future funding for the further development of its product candidates such as BX-1000, BX-2000 and BX-3000, the ability of Baudax Bio to pay its debt and meet the conditions necessary to access future debt tranches, Baudax Bio’s ability to comply with other commitments under its credit facility, Baudax Bio’s ability to manage costs and execute its operational and budgetary plans, Baudax Bio to achieve its financial objectives; and Baudax Bio’s ability to successfully obtain, maintain and enforce patents and other intellectual property protections. These forward-looking statements should be viewed with the risks and uncertainties that may affect Baudax Bio’s business and future results included in the documents filed by Baudax Bio 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.
Investor Relations Contact:
Argot Partners Sam Martin / Claudia Styslinger (212) 600-1902 [email protected]
Argot Partners David Rosen (212) 600-1902 [email protected]