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Baudax Bio Announces Dosing of First Cohort in First-in-Man, Phase I Clinical Study Evaluating BX2000

2022-06-01 08:00 ET - News Release

MALVERN, Pa., June 01, 2022 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX) a pharmaceutical company focused on innovative products for acute care settings, today announced that the first cohort has been dosed in a First-in-Man, Phase 1 clinical study evaluating the safety, tolerability and pharmacokinetics of BX2000, a rapid onset, ultra-short acting neuromuscular blocking (NMB) agent, in healthy volunteers.

This double-blind, placebo-controlled study will investigate single ascending doses of BX2000 administered as an intravenous bolus injection compared to placebo. The study is comprised of up to 10 dosing cohorts and each cohort will enroll 8 patients. The study will evaluate the effect of BX2000 on safety, including heart rate, blood pressure, corrected QT interval, pharmacokinetics, and the time course of the neuromuscular blocking profile. Subjects will be monitored at an inpatient facility for 24 hours following administration of BX2000. There will also be follow-up visits conducted on Day 8 and follow-up will take place approximately 2 and 4 weeks after dosing to determine the continued safety of study participants.

"The commencement of this first-in-humans clinical study for BX2000, our ultra-short acting NMB, is an important step in this clinical development program and we look forward to assessing the safety, PK and profile as the study completes enrollment in late 2022 or early 2023," said Gerri Henwood, Baudax Bio's President and Chief Executive Officer. "We believe our NMBs, including BX1000 and BX2000, have the potential to reduce the time required for intubation and the onset of anesthesia and the time needed to recover from dosing post-procedure, all while enhancing patient safety and providing significant cost savings for providers. We believe this could answer clinician described needs in the anesthesia space and give physicians new alternatives in a wide array of procedures and surgical settings."

About Baudax Bio's Neuromuscular Blocking Agents (NMBs)

Baudax Bio holds exclusive global rights to two novel NMBs, BX1000, an intermediate duration, clinical stage agent, and BX2000, an ultra-short duration, clinical stage agent, and a proprietary chemical reversal agent, BX3000, that is specific to, and rapidly reverses, BX1000 and BX2000. All three agents were licensed from Cornell University in 2017. Used together, these agents allow for a very rapid induction of neuromuscular blockade for surgical settings, followed by a rapid reversal of the neuromuscular blockade. These novel agents have the potential to meaningfully reduce procedure recovery time in operating room or post-acute care settings, resulting in valuable cost savings to hospitals and ambulatory surgical centers.

About Baudax Bio

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.

Forward-Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements 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 on this internet site, including statements relating to the development of each of BX1000 and BX2000, 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, 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; 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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