Leading BioSciences Teams with Donnelley Financial Solutions to Create Innovative Study Tool for Clinical Trial Monitoring Du...
June 09 2020 - 08:00AM
Business Wire
Novel application will enable Leading
BioSciences to remotely monitor phase 2 study data in patients with
COVID-19 pneumonia
Donnelley Financial Solutions (NYSE: DFIN), a
leading risk and compliance company, today announced that Leading
BioSciences, Inc. (LBS), a drug development company focused on
improving human health through therapeutic protection of the
intestinal mucosal barrier, is working with DFIN to manage remote
monitoring of their COVID-19 study.
LBS is taking a unique approach to investigating treatments for
COVID-19 by targeting gut integrity as a potential method of
disrupting viral infection and potentially reducing
life-threatening complications. The U.S. Food and Drug
Administration (FDA) recently cleared LBS to conduct a phase 2
study of its lead investigational drug, LB1148, for the “treatment
of pulmonary dysfunction associated with COVID-19 pneumonia.”
To carry out this study, LBS faces the challenge of collecting
and monitoring patient data during a global pandemic with
widespread implementation of shelter-in-place orders and hospital
policy revisions prohibiting non-essential visitors.
Just as COVID-19 began to impact onsite clinical study
monitoring operations across the globe, LBS began working with DFIN
to utilize Venue® virtual data rooms as an innovative solution to
virtually monitor patient data. Use of virtual data rooms allows
LBS to continue trial operations and oversight in the absence of
in-person visits to hospitals and clinical sites. LBS’s use of
Venue® has proven to be a fast-track solution that reduces costs
and has changed the way the company manages clinical trial
execution. By allowing remote monitoring and source document
verification of clinical study data, LBS has been able to continue
its development activities without compromising the safety of
patient volunteers, or that of company and CRO team members.
“DFIN has revolutionized our management of the clinical trial
monitoring process with their Venue data rooms,” said Inge K. Bear,
Chief Development Officer at Leading BioSciences. “We have been
able to reduce study costs, increase efficiency, maintain a safe
work environment, and abide by all local, state and federal
guidelines in the process. We will be incorporating Venue as part
of our ‘new normal’ for managing clinical trial monitoring. Despite
the operational disruptions of COVID-19, LBS will emerge as a more
efficient organization because of our work with DFIN.”
“We are honored to be working with a company like Leading
BioSciences who is on the forefront of combating the
life-threatening complications related to COVID-19,” said Craig
Clay, president of Global Capital Markets at DFIN. “While using our
Venue solution, LBS has been able to securely and efficiently
manage their investigational drug studies, while also reducing
costs.”
About Donnelley Financial Solutions (DFIN) DFIN is a
leading global risk and compliance solutions company. We provide
domain expertise, enterprise software and data analytics for every
stage of our clients’ business and investment lifecycles. Markets
fluctuate, regulations evolve, technology advances, and through it
all, DFIN delivers confidence with the right solutions in moments
that matter. Learn about DFIN’s end-to-end risk and compliance
solutions online at DFINsolutions.com or you can also follow us on
Twitter @DFINSolutions or on LinkedIn.
Forward-Looking Statements This news release may contain
"forward-looking statements" within the meaning of Section 21E of
the Securities Exchange Act of 1934, as amended, and the U.S.
Private Securities Litigation Reform Act of 1995. Readers are
cautioned not to place undue reliance on these forward-looking
statements and any such forward-looking statements are qualified in
their entirety by reference to the following cautionary statements.
All forward-looking statements speak only as of the date of this
news release and are based on current expectations and involve a
number of assumptions, risks and uncertainties that could cause the
actual results to differ materially from such forward-looking
statements. Readers are strongly encouraged to read the full
cautionary statements contained in Donnelley Financial Solutions’
(DFIN) filings with the SEC. Donnelley Financial Solutions (DFIN)
disclaims any obligation to update or revise any forward-looking
statements.
About Leading BioSciences Leading BioSciences is
developing novel therapeutics designed to improve human health
through therapeutic protection of the Gastrobiome™. The Company’s
initial focus is combatting the interruption of GI function (ileus)
following major surgery to reduce recovery times and shorten
patients’ length of stay in the hospital. Additionally, the company
believes that its investigational therapies have the potential to
prevent the formation of post-operative adhesions (reducing
hospital re-admissions and additional surgeries), as well as to
address the myriad health conditions and complications associated
with chronic disruption of the intestinal mucosal barrier. Learn
more at: www.leadingbiosciences.com.
About LB1148 LB1148 is a patent-protected formulation of
a broad-spectrum serine protease inhibitor designed to neutralize
the activity of potent digestive proteases that can cause a range
of serious complications and organ dysfunction if they escape the
GI tract through a compromised mucosal barrier. By inhibiting the
activity of digestive proteases, LB1148 has the potential to
prevent damage to GI tissues, speed the return of GI function and
shorten patients’ post-surgery stay in the ICU and hospital. This
could substantially reduce the burden on the healthcare system
based on the average cost of both ICU and hospital stays following
cardiovascular surgery. LB1148 has not been approved for use in any
indication, nor has it been deemed by FDA as “safe” for use in any
patient population.
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version on businesswire.com: https://www.businesswire.com/news/home/20200609005023/en/
DFIN Media Contact: Michelle Therrien
media@dfinsolutions.com
Leading BioSciences Media Contact: Jules Abraham
jabraham@jqapartners.com
DFIN Investor Contact: Justin Ritchie
investors@dfinsolutions.com
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