Baudax Bio Announces Positive Outcome of Interim Analysis of Phase II Randomized Trial for BX1000
25 January 2023 - 12:00AM
Baudax Bio, Inc. (NASDAQ:BXRX) a pharmaceutical company focused on
innovative products for hospital and related settings, today
announced the successful outcome of its first interim analysis in a
Phase II trial of BX1000 for neuromuscular blockade (NMB) in
patients undergoing elective surgery.
“We are encouraged by the results of the first
interim analysis of the BX1000 Phase II surgery trial,” said Gerri
Henwood, Baudax Bio’s President and Chief Executive Officer. “We
believe the use of BX1000, combined with our reversal agent,
BX3000, could make for precise control of timing under
neuromuscular paralysis for surgical patients, which could result
in time and cost savings for patients and hospitals alike. We look
forward to completing enrollment in the study in Q1 and sharing
topline results for the study in April 2023.”
This randomized, double-blind, active-controlled
clinical trial comparing three different doses of BX1000 to a
standard dose of rocuronium is planned to enroll a total of 80
adult patients undergoing elective surgery utilizing total
intravenous anesthesia. The primary efficacy endpoint is the
proportion of patients meeting criteria for Good or Excellent
intubating conditions using a standardized scale. Additionally, the
trial is evaluating the safety and tolerability profile of BX1000
and rocuronium in this patient population.
This pre-planned interim analysis evaluated the
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
subjects were successfully intubated following the assessment at 60
seconds, and the one remaining subject following the assessment at
90 seconds. Study treatments were generally well tolerated with no
occurrence of severe or serious adverse events.
This 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.
About Baudax Bio’s Neuromuscular
Blocking Agents (NMBs)
Baudax Bio holds exclusive global rights to two
novel NMBs, BX1000, an intermediate duration, clinical stage
blocking agent, and BX2000, an ultra-short duration, clinical stage
blocking 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. 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 time to onset of
blocking and of reversal of blockade, reducing time in operating
rooms or post-acute care settings, resulting in potential clinical
and cost advantages, as well as time-related valuable cost savings
for 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. These forward-looking statements, which include
statements relating to the development of each of BX1000 and
BX3000, are based on information available to Baudax Bio as of the
date of this press release and are subject to a number of risks,
uncertainties, and other factors that could cause actual results 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; 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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