Baudax Bio Initiates Phase II Clinical Trial Evaluating BX1000 in Patients Undergoing Surgery
09 December 2022 - 12:00AM
Baudax Bio, Inc. (NASDAQ:BXRX) a pharmaceutical company focused on
innovative products for hospital and related settings, today
announced the initiation of a clinical study evaluating the safety,
tolerability profile, and intubation conditions of BX1000 for
neuromuscular blockade (NMB) in patients undergoing elective
surgery.
This randomized, double-blind clinical trial
will study BX1000 in approximately 80 adult patients, 18-65 years
of age, who undergo elective surgery utilizing total intravenous
anesthesia (TIVA) in an outpatient setting. Patients will undergo
elective surgery with an intravenous (IV) line for anesthesia and
study drug administration. Once anesthetized, neuromuscular
monitoring will be initiated via electromyography (EMG), and
approximately 3-5 minutes after induction of anesthesia, the
randomized NMB treatment will be administered as an IV bolus.
Intubation conditions will be assessed at 60 seconds after
administration of the NMB dose and will be reassessed at 90 and 120
seconds if needed, with tracheal intubation performed when
clinically acceptable conditions are identified. These “intubating
conditions” represent the endpoint for NDA approval for NMB agents.
Following successful tracheal intubation, patients will proceed to
undergo their elective surgical procedures according to the
standard practice of the investigator or surgical unit. Patients
will be monitored post-surgery in the anesthesia recovery area and
will be transferred to the inpatient facility where they will
remain for at least 8 hours following NMB administration, to be
discharged at the discretion of the investigator. There will be an
in-person follow-up visit and several telephonic safety follow ups
as well.
“The initiation of this Phase II clinical study
in patients undergoing elective surgery is an important step for
the overall NMB program, and we look forward to data on BX1000’s
safety, tolerability, and neuromuscular blocking profile,” said
Gerri Henwood, Baudax Bio’s President and Chief Executive Officer.
“We believe that BX1000, in combination with BX3000 (reversal
agent), may permit precise control of the time patients are under
neuromuscular paralysis. This could be significantly impactful for
patients, surgeons, and anesthesiologists by enhancing safety, and
possibly saving time and reducing costs related to delayed recovery
from neuromuscular paralysis following surgical procedures. To
date, no serious adverse events have been reported in the first
group of patients enrolled and efficacy parameters have been
recorded. We look forward to announcing the completion of the
pre-planned first interim analysis of the BX1000 Phase 2 surgery
trial early in 2023, with a target of completing full study
enrollment by the end of March, 2023.”
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, as well
as a proprietary chemical reversal agent, BX3000, undergoing
nonclinical studies intended to support an IND filing in 2023.
BX3000 is a specific reversal agent that rapidly reverses BX1000
and BX2000. All three agents are licensed from Cornell University.
Used together, we believe 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 rooms 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 hospital and related settings. The
Company has a pipeline of innovative pharmaceutical assets
including two clinical-stage, novel neuromuscular blocking (NMBs)
agents, one in a Phase II study and an additional unique NMB in a
dose escalation Phase I study, as well as a proprietary chemical
reversal agent specific to these NMBs. Baudax Bio has received
approval for and marketed ANJESO®, the first and only 24-hour,
intravenous (IV) COX-2 preferential non-opioid, non-steroidal
anti-inflammatory (NSAID) for the management of moderate to severe
pain. 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. Forward-looking statements may include, without
limitation, statements regarding the use of net proceeds from the
offering. These forward-looking statements are based on information
available to Baudax Bio as of the date of publication on this
internet site, including Baudax Bio’s ability to realize any
anticipated benefits from the reverse stock split, including
maintaining its listing on the Nasdaq Capital Market and attracting
new investors. 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;
Baudax Bio’s ability to comply with all listing requirements of 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.
CONTACT:
Investor Relations Contact:
Argot PartnersSam Martin / Kaela Ilami(212)
600-1902baudaxbio@argotpartners.com
Media Contact:
Argot PartnersDavid Rosen(212)
600-1902david.rosen@argotpartners.com
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