Baudax Bio Stock

Baudax Bio, Inc. operates as a pharmaceutical company primarily focused on products for hospital and related settings.

The company can bring valuable therapeutic options for patients, prescribers and payers to the hospital and related markets.

The company holds exclusive global rights to two new molecular entities, which are centrally acting Neuromuscular Blocking Agents (NMBs), BX1000, an intermediate duration of action NMB undergoing a Phase II clinical trial, and BX2000, an ultra-short acting NMB undergoing a Phase I clinical trial, as well as a proprietary blockade reversal agent, BX3000, being evaluated in preclinical studies intended to support an IND filing in 2023. BX3000 is an agent that is expected to rapidly reverse BX1000 and BX2000 blockade. All three agents are licensed from Cornell University. These agents, when administered in succession, will allow for a rapid onset of centrally acting neuromuscular blockade, followed by a rapid reversal of the neuromuscular blockade with BX3000. These novel agents have the potential to meaningfully reduce time to onset of blocking and of reversal of blockade, reducing time in operating rooms or post operative suites (PACU), resulting in potential clinical and cost advantages, as well as valuable cost savings for hospitals and ambulatory surgical centers.

In mid-2020, the company launched its first commercial product, ANJESO, in the United States. ANJESO is the first and only 24-hour, intravenous, or IV, analgesia agent. ANJESO is a cyclooxygenase-2, or COX-2, preferential, non-steroidal anti-inflammatory, or NSAID, for the management of moderate to severe pain, which could be administered alone or in combination with other non-NSAID analgesics. The company successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and two Phase IIIb programs evaluating ANJESO's clinical safety and efficacy along with its positive health economic impacts in specific surgical settings. As many sources have documented, many hospitals have suffered great economic impacts associated with the Covid-19 pandemic and with its continuing impact on surgery rates, as well as the impacts of the 'Great Resignation' of 2021 and beyond, impacting nursing and other professional staff available to support surgery and post operative care.

Strategy

In addition to the company's pipeline, the company continues to evaluate acquisition and in-licensing opportunities.

Pipeline Candidates

The company's pipeline includes clinical and early-stage product candidates, including the NMB and Reversal agents that the company is developing for use in hospital and related settings.

NMBs

The company is developing an intermediate-acting NMB, BX1000, an ultra- short acting NMB, BX2000, and a reversal agent specific to the company's NMBs, BX3000.

The company has a worldwide, exclusive license to the NMBs and the related reversal agent from Cornell University.

BX1000

The company completed a Phase I study in 2021 for BX1000 which evaluated its safety profile when administered with Total Intravenous Anesthesia, as well as the dose response of neuromuscular blockade. The company completed a dose-escalation study evaluating BX1000 in a total of 58 healthy volunteers who had already undergone endotracheal intubation while under general anesthesia. After intubation, subjects received a single IV bolus dose of BX1000 and were monitored for neuromuscular blockade and for any changes in vital signs or the presence of adverse events. BX1000 dose-escalations were continued until prespecified effects were observed. Doses of BX1000, up to 0.4 mg/kg, were well tolerated in this study of healthy volunteer subjects. Muscle paralysis was rapidly achieved along with complete spontaneous recovery. Neuromuscular blocking parameters were observed to increase in depth and duration of blockade while the time to onset of blockade was reduced with increasing doses of BX1000. Pharmacokinetic exposures increased with increasing study doses while elimination of the study compound remained rapid. Evaluation of electrocardiogram data using concentration-QTc modeling did not identify a risk of QTc prolongation within the studied dosing range. The company engaged with the FDA regarding the design for the Phase II study in patients undergoing elective hernia and similar abdominal surgical procedures utilizing total intravenous anesthesia, in the fall of 2022, and initiated enrollment in the study in the fourth quarter of 2022. In January 2023, the company announced the positive outcome of the interim analysis of the randomized, double blind, active controlled clinical Phase II trial, which compared three doses of BX1000 to a standard dose of rocuronium. The interim analysis was performed without breaking the study blind and was based on the first 20 of the 80 total patients being enrolled to the 4 study arms. The primary efficacy endpoint was the proportion of patients meeting criteria for Good or Excellent intubating conditions using a standardized scale. Additionally, the study is evaluating the safety and tolerability of BX1000 as compared to rocuronium in this patient population. The company expects the Phase II study to be complete by the first half of 2023.

The pre-planned interim analysis evaluated intubating conditions for each patient after administration of study drug in a blinded fashion. In the 20 patient cohort, 5 patients per group received one of the study medications. All 20 patients were observed to have met the criteria for Good or Excellent intubating conditions at 60 seconds. Nineteen of the patients were successfully intubated at 60 seconds, with one remaining patient successfully intubated following the assessment at 90 seconds. Study treatments were generally well tolerated with no occurrence of severe or serious adverse events. The blinded interim analysis did not result in the decision to drop any of the four study groups nor any decision to adjust planned study enrollment numbers.

BX2000

The company filed an IND for BX2000 in 2020 in order to conduct a first-in-human clinical trial. The company conducted an additional toxicology study requested by the FDA in 2021 and in March 2022, FDA notified the company that it could proceed with initiation of a first in human, Phase I dose-escalation study in healthy volunteers.

In June of 2022, the company announced the completion of dosing of the first cohort of the Phase I dose escalation study for BX2000, which to be a rapid onset, ultra-short acting NMB agent, in healthy volunteers. The study is investigating single, ascending doses of BX2000 administered in a single, intravenous bolus injection compared to placebo. The study is consisted 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 are also follow up visits on Day 8 and additional follow ups will take place approximately 2 and 4 weeks after dosing to evaluate the continued safety of study participants.

Enrollment began in the second quarter of 2022 and cohort 2 completed, as planned, in the fourth quarter of 2022. Enrollment in cohort 3 was underway in January 2023 and despite the challenges of enrollment to this type of protocol, the company remains optimistic that the company will be close to reaching maximum dosage by late 2023 to mid-2024.

BX3000

BX3000 is a small molecule that was designed to induce chemical cleaving of BX1000 and BX2000, resulting in the rapid inactivation of those molecules and thus quickly reversing neuromuscular blockade. The company is engaged with the pre-clinical toxicity studies needed to support an IND for BX3000 in the summer of 2023. The company expects to begin the clinical program for BX3000 in 2023.

Intellectual Property

The company licenses the patents and other intellectual property covering the NMBs and the related reversal agent and related methods of use under a worldwide, exclusive, sublicensable, royalty-bearing license from Cornell. The company exclusively licenses issued patents in the U.S. and other major foreign markets directed to BX1000 that expire in 2027, subject to any applicable extension, along with a pending PCT application directed to certain methods of using BX1000 that, if issued, would expire in 2041, subject to any applicable disclaimer or extension. The company exclusively licenses issued patents in the U.S. and other major foreign markets directed to BX2000 that expire in 2033, subject to any applicable extension, along with a pending PCT application directed to certain methods of using BX-2000 that, if issued, would expire in 2041, subject to any applicable disclaimer or extension.

The company owns patents and patent applications directed to the analgesia indication, formulations and intranasal methods of use of dexmedetomidine, or Dex, in the United States and certain major foreign markets. Several patents have issued outside the United States for transmucosal methods, and the resulting patent protection will last into 2030, subject to any disclaimers or extensions. In addition, patents related to intranasal methods has issued in the United States and certain major foreign markets, and the resulting patent protection will last into 2032, subject to any disclaimers or extensions.

The company owns patents and patent applications for injectable meloxicam, that cover pharmaceutical compositions, including compositions produced using NanoCrystal technology, method of making injectable meloxicam and method of treating pain with injectable meloxicam. These issued patents expire between 2024 and 2039 in the United States, and the pending applications, if issued, would expire between 2030 and 2039. The company also exclusively licenses from Alkermes, on a perpetual, royalty-free basis, composition and methods of making patents, and patent applications directed to the prevention of flake like aggregates to manufacture and commercialize IV, intramuscular or parenteral meloxicam, which begin to expire in 2030.

Government Regulation

The company's product candidates must be approved by the FDA before they may legally be marketed in the United States.

The company is also subject to the U.K. Bribery Act, and other third country anti-corruption laws and regulations pertaining to the company's financial relationships with foreign government officials.

The company's dealings with these prescribers and purchasers are subject to regulation under the Foreign Corrupt Practices Act.

Research and Development

The company's research and development expenses were $3.9 million for the year ended December 31, 2022.

History

Baudax Bio, Inc. was founded in 2019. The company was incorporated under the laws of the Commonwealth of Pennsylvania in 2019.