TIDMPRTC
PureTech Health PLC
05 October 2020
5 October 2020
PureTech Health plc
PureTech Founded Entity Alivio Therapeutics Awarded $3.3 Million
from US Department of Defense
Award will support advancement of ALV-304 into the clinic for
the potential treatment of inflammatory bowel disease
PureTech Health plc (LSE: PRTC) ("PureTech" or the "Company"), a
clinical-stage biotherapeutics company dedicated to discovering,
developing and commercialising highly differentiated medicines for
devastating diseases, is pleased to note that its Founded Entity,
Alivio Therapeutics, today announced a $3.3 million US Department
of Defense (DoD) Technology/Therapeutic Development Award to
advance its product candidate, ALV-304, for the treatment of
inflammatory bowel disease (IBD).
Alivio's inflammation-targeting, disease immunomodulation
approach involves selectively restoring immune homeostasis at
inflamed sites in the body, while having minimal impact on the rest
of the body's immune system. The DoD funds will support Alivio's
preclinical research and development activities to potentially
enable the filing of an investigational new drug (IND) application
for ALV-304.
The full text of the announcement from Alivio Therapeutics is as
follows:
Alivio Therapeutics Awarded $3.3 Million from US Department of
Defense
Award will support advancement of ALV-304 into the clinic for
the potential treatment of inflammatory bowel disease
BOSTON, October 5, 2020 - Alivio Therapeutics , a biotechnology
company developing an inflammation-targeting disease
immunomodulation platform for the potential treatment of chronic
and acute inflammatory disorders, today announced a $3.3 million US
Department of Defense (DoD) Technology/Therapeutic Development
Award to advance its product candidate, ALV-304, for the treatment
of inflammatory bowel disease (IBD). The funds will support
Alivio's preclinical research and development activities to
potentially enable the filing of an investigational new drug (IND)
application for ALV-304.
Alivio's inflammation-targeting, disease immunomodulation
approach involves selectively restoring immune homeostasis at
inflamed sites in the body, while having minimal impact on the rest
of the body's immune system. Alivio's proprietary platform has
demonstrated proof-of-concept in ten different preclinical models
of inflammation. In multiple preclinical models for the treatment
of IBD, ALV-304 showed significant improvements in several efficacy
endpoints compared to untreated controls. Furthermore, the
inflammation-targeting properties were shown to result in very low
systemic blood levels, which has the potential to limit systemic
side effects.
"Our novel platform technology has the potential to generate
inflammation-targeting therapies for the treatment of many acute
and chronic inflammatory diseases using biologics, small molecules
or drug combinations in an oral formulation. IBD as an indication
is a great pairing of our technology and an important clinical
need," said Brian Leuthner, chief executive officer at Alivio.
"ALV-304 could potentially offer a novel therapeutic option to
improve the health of patients living with moderate to severe forms
of IBD. We are excited by this potential and the DoD award that
will support our efforts to advance ALV-304 into the clinic."
IBD is estimated to affect approximately three million people in
the United States, and other autoimmune diseases affect over 20
million people in the United States. Many of the existing
interventions are limited by toxicities and systemic immune
suppression.
"Although patients with mild forms of inflammatory bowel disease
can be effectively managed, there is a large unmet need for
patients with moderate to severe forms of the disease that are
refractory to current therapies," said Athos Bousvaros, MD, MPH,
professor and associate chief, Division of Gastroenterology,
Hepatology and Nutrition; associate director, Inflammatory Bowel
Disease program at Harvard Medical School. "I am excited by the
potential of ALV-304 to treat these patients and I am hopeful that
this award will accelerate development of this potentially new
therapy for IBD."
Alivio is developing product candidates that are designed to
selectively treat autoimmune disease without having related
systemic toxicities. Alivio's pipeline includes candidates for IBD,
pouchitis, and interstitial cystitis or bladder pain syndrome
(IC/BPS).
About the US Department of Defense Award
The US Army Medical Research Acquisition Activity, 820 Chandler
Street, Fort Detrick MD 21702-5014 is the awarding and
administering acquisition office. This work is supported by the
Office of the Assistant Secretary of Defense through the Peer
Reviewed Medical Research Program under Award No. W81XWH-20-10645.
Opinions, interpretations, conclusions and recommendations are
those of the author and are not necessarily endorsed by the
Department of Defense.
About Alivio Therapeutics
Alivio Therapeutics, Inc. is a biotechnology company pioneering
inflammation-targeting disease immunomodulation as a novel strategy
to treat a range of chronic and acute inflammatory disorders. This
long sought-after approach involves selectively restoring immune
homeostasis at inflamed sites in the body, while having minimal
impact on the rest of the body's immune system. Alivio's approach
has the potential to broadly enable new medicines to treat a range
of chronic and acute inflammatory disorders, including enabling the
use of drugs which were previously limited by issues of systemic
toxicity or pharmacokinetics.
Alivio is developing a proprietary platform centred on a class
of self-assembling therapies that selectively bind to inflamed
tissue. Alivio's platform has been in highlighted in peer-reviewed
journals, including in Science Translational Medicine and Nature
Communications and has been validated in multiple labs using a
range of animal models and indications. The platform can enable a
wide array of active pharmaceutical ingredients (APIs), including
small molecules, biologics and nucleic acids . Alivio's pipeline
includes candidates for IBD, pouchitis, and interstitial cystitis
or bladder pain syndrome, or IC/BPS.
Alivio was founded by PureTech (LSE: PRTC) and leading
immunology experts Jeffrey Karp, PhD , Professor of Medicine at
Brigham and Women's Hospital and Robert Langer, ScD , David H. Koch
Institute Professor at MIT .
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated
to discovering, developing and commercialising highly
differentiated medicines for devastating diseases, including
intractable cancers, lymphatic and gastrointestinal diseases,
central nervous system disorders and inflammatory and immunological
diseases, among others. The Company has created a broad and deep
pipeline through the expertise of its experienced research and
development team and its extensive network of scientists,
clinicians and industry leaders. This pipeline, which is being
advanced both internally and through PureTech's Founded Entities,
is comprised of 24 products and product candidates, including two
that have received US Food and Drug Administration (FDA) clearance
and European marketing authorisation. All of the underlying
programmes and platforms that resulted in this pipeline of product
candidates were initially identified or discovered and then
advanced by the PureTech team through key validation points based
on the Company's unique insights into the biology of the brain,
immune and gut, or BIG, systems and the interface between those
systems, referred to as the BIG Axis.
For more information, visit www.puretechhealth.com or connect
with us on Twitter @puretechh.
Forward Looking Statement
This press release contains statements that are or may be
forward-looking statements, including statements that relate to the
company's future prospects, developments, and strategies. The
forward looking statements are based on current expectations and
are subject to known and unknown risks and uncertainties that could
cause actual results, performance and achievements to differ
materially from current expectations, including, but not limited
to, our expectations regarding the potential clinical development
and therapeutic benefit of ALV-304, the filing of an IND for
ALV-304 and the use of the DoD award to further develop ALV-304 and
those risks and uncertainties described in the risk factors
included in the regulatory filings for PureTech Health plc. These
forward-looking statements are based on assumptions regarding the
present and future business strategies of the company and the
environment in which it will operate in the future. Each
forward-looking statement speaks only as at the date of this press
release. Except as required by law and regulatory requirements,
neither the company nor any other party intends to update or revise
these forward-looking statements, whether as a result of new
information, future events or otherwise.
Contact:
Investors EU media US media
Allison Mead Talbot Ben Atwell, Rob Winder Stephanie Simon
+1 617 651 3156 +44 (0) 20 3727 1000 +1 617 581 9333
amt@puretechhealth.com ben.atwell@FTIconsulting.com stephanie@tenbridgecommunications.com
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END
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