Amazing Results: Baudax Bio Reveals Positive Outcomes of Clinical Trial for BX1000

Baudax Bio, Inc. (Nasdaq:BXRX), a pioneering pharma company dedicated to creating innovative medications for acute care, just revealed promising new outcomes from a Phase 2 clinical trial involving their lead product: BX1000. By measuring NMB response using electromyography, this drug candidate proved to be a powerful alternative to rocuronium in elective surgical procedures. This is a groundbreaking development in the field of acute care!

The BX1000 Phase 2 Surgery Trial was an exciting double-blind, active-controlled clinical trial comparing three different doses of BX1000 against a standard dose of rocuronium in 80 adult patients undergoing elective surgery with total intravenous anesthesia.

A total of 81 people were randomized into the four treatment groups, with the primary efficacy endpoint of the study being whether the patients met criteria for good or excellent intubating conditions within a standardized scale.

Excitingly, all patients, no matter which regimen they were in, met the primary efficacy criteria with flying colours! Moreover, the clinical trial also showed an excellent safety and tolerability profile of both BX1000 and rocuronium in this patient population.

The EMG data provided a clear indication of the effectiveness of BX1000 for maximum T1 suppression, with 1.5x ED95 dose of BX1000 resulting in equivalent results to the 2X ED95 dose of rocuronium. Moreover, the “time to 80% NMB” between BX1000’s highest dose of 0.35 mg/kg and rocuronium’s 0.66 mg/kg was approximately the same. In terms of recovery measures, the “full recovery” for BX1000 at its highest dose of 0.35 mg/kg and rocuronium at 0.60 mg/kg was identical, but the margins for BX1000 were much tighter and more predictable.

Baudax Bio’s Chief Medical Officer Stewart Mc Callum, MD, is thrilled with the latest clinical results that further support the conclusions drawn from the original outcome data announced in April. The data demonstrates that BX1000 at the highest dose compares favorably to rocuronium, and when combined with BX3000 as a reversal agent, the regimen may provide improved control of neuromuscular paralysis for surgical patients. This could be the first major innovation in NMB in decades, and Baudax Bio is eager to discuss the results with investigators and advisors in order to advance BX1000 forward.

Dr. Todd M. Bertoch, Chief Executive Officer of JBR Clinical Research and Investigator for the trial of the game-changing neuromuscular blocking agent BX1000, is excited for the possibility of having one reversal agent (BX3000) that could act on both the short and long acting drugs (BX2000 and BX1000). This cost-competitive family of agents could provide ideal control of neuromuscular paralysis in certain anesthetic situations and make tailored anesthetic treatments accessible. This would be a major breakthrough in the world of anesthesiology.

About Baudax Bio’s Neuromuscular Blocking and Reversal Agents (NMB)

Baudax Bio holds exclusive rights to three powerful and innovative NMB agents developed by Cornell University: BX1000, a clinical-stage blocking agent with intermediate duration; BX2000, an ultra-short duration clinical-stage blocking agent; and BX3000, a proprietary chemical reversal agent currently undergoing nonclinical studies.

These agents have the potential to revolutionize the way surgery is performed, drastically reducing operating room time and post-acute care costs. The remarkable speed and absolute control of the neuromuscular blockade provided by these agents makes them a desirable alternative for both healthcare providers and patients. Thanks to these novel agents, medical care may never be the same again.

About Baudax Bio

At Baudax Bio, we strive to revolutionize the acute care space with our innovative product pipeline. Our clinical-stage novel neuromuscular blocking (NMB) agents, currently undergoing Phase I and II trials, are pushing the boundaries of modern healthcare. Alongside these medicines, we are also developing a proprietary chemical reversal agent specific to these NMBs. We expect to file an IND in the summer of 2023 after nonclinical and manufacturing studies are completed, allowing us to bring our products to market.

Forward Looking Statements

The future of Baudax Bio’s product candidates is full of promise and potential, but it also carries substantial risks and uncertainties. With the ongoing economic and social consequences of the COVID-19 pandemic, a number of risks may prevent Baudax Bio from realizing its vision, including the ability to advance its product candidates through pre-clinical and clinical trials, the potential for interim results to differ from final results, the possibility of regulatory disapproval, and the need to secure financing for continued development.

Along with these risks, Baudax Bio must also manage its costs, meet the financial and other covenants of its credit facility, maintain Nasdaq listing, and preserve its intellectual property. All of these are necessary steps for Baudax Bio to achieve its goals. But for now, Baudax Bio is optimistic about the future of its product candidates, such as BX1000, BX2000, and BX3000, and remains focused on the potential gains ahead.

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