TIDMPRTC
PureTech Health PLC
12 September 2018
12 September 2018
PureTech Health plc
PureTech's Alivio Awarded $3.3 Million Grant from the US
Department of Defense to Advance Product Candidate for the
Treatment of Interstitial Cystitis/Bladder Pain Syndrome
Award to advance product candidate towards potential
investigational new drug filing
PureTech Health plc (LSE: PRTC) ("PureTech Health"), an advanced
biopharmaceutical company developing novel medicines for
dysfunctions of the Brain-Immune-Gut (BIG) Axis, is pleased to note
that Alivio Therapeutics, Inc., an affiliate of PureTech Health,
today announced a $3.3 million US Department of Defense (DoD)
Technology/Therapeutic Development Award. The funds will support
Alivio's preclinical research and development activities for
product candidate, ALV-107, which is being advanced for the
treatment of interstitial cystitis/bladder pain syndrome (IC/BPS)
with Hunner's lesions.
Joseph Bolen, PhD, Chief Scientific Officer at PureTech Health,
said: "Existing therapies for inflammatory diseases are often
limited by side effects or a lack of clinically meaningful efficacy
primarily due to a narrow therapeutic window. This grant provides
further validation of the substantial opportunity to advance
Alivio's inflammation-targeting technology as a new approach to
address inflammatory diseases at the sites of inflammation and to
potentially provide a new therapeutic option for diseases, such as
interstitial cystitis, where there is a major unmet need."
The full text announcement from Alivio is as follows:
US Department of Defense Awards $3.3 Million Grant to Alivio
Therapeutics
Research award will support preclinical activities to advance
product candidate for the treatment of interstitial
cystitis/bladder pain syndrome into the clinic
BOSTON, September 12, 2018 - Alivio Therapeutics, an affiliate
of PureTech Health plc (LSE: PRTC) developing therapies to treat
inflammatory disorders through targeted disease immunomodulation,
today announced a $3.3 million US Department of Defense (DoD)
Technology/Therapeutic Development Award to advance Alivio's
product candidate, ALV-107, for the treatment of interstitial
cystitis/bladder pain syndrome (IC/BPS) with Hunner's lesions. The
funds will support Alivio's preclinical research and development
activities, including GMP manufacturing, to enable the filing of an
investigational new drug (IND) application for ALV-107.
Alivio's inflammation-targeting technology is designed to
administer therapeutics to the sites of inflammation, while sparing
healthy tissue. The technology is also engineered to respond
dynamically to inflammation, releasing the entrapped therapeutics
based on the degree of inflammation present. This approach is being
evaluated across a variety of diseases, including IC/BPS,
pouchitis, and inflammatory bowel disease (IBD).
J Curtis Nickel, MD FRCSC, Professor, CIHR Canada Research Chair
in Urologic Pain and Inflammation at Queen's University, said:
"Interstitial cystitis is one of the most important unmet needs in
urology. New therapies that can offer long-lasting relief from the
pain associated with the disease would make a major impact in the
lives of patients. I am hopeful that this award will accelerate
development of this potentially new therapy for interstitial
cystitis/bladder pain syndrome and look forward to seeing ALV-107's
impact in the clinic."
"Our inflammation-targeting technology approach has the
potential to treat a range of chronic and acute inflammatory
disorders, such as interstitial cystitis/bladder pain syndrome with
Hunner's lesions, that would otherwise be difficult to treat," said
Eric Elenko, PhD, PureTech's Chief of Strategy and Research and
Alivio Co-founder. "ALV-107 could potentially offer a novel
therapeutic option to improve the health of patients living with
this devastating disease, and this award will help to support our
effort to advance ALV-107 towards the clinic."
Alivio's platform technology has demonstrated proof-of-concept
in ten different preclinical models of inflammation including a
validated preclinical model for the treatment of IC/BPS. ALV-107
showed durable pain control throughout a 24-hour study period in
this model of IC/BPS, lasting at least 12 times longer than
lidocaine at a comparable dose (ALV-107 16 mg/kg, conventional
lidocaine 16 mg/kg). Beyond ALV-107, Alivio is advancing additional
product candidates to enable new immunomodulatory therapies and
active pharmaceutical ingredients (APIs), including biologics, and
nucleic acids for inflammatory conditions of the GI tract and other
parts of the body.
About Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) and
Hunner's Lesions
Interstitial Cystitis or Bladder Pain Syndrome (IC/BPS) is a
chronic bladder condition that consists of discomfort or pain in
the bladder or surrounding pelvic region and is often associated
with frequent urination. It is estimated to affect up to 12 million
people in the US and is more common in women than men. Current
treatments fail to control pain in many patients, particularly
patients with Hunner's lesions, which are estimated to affect 5-10%
of IC/BPS patients in the US.
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-18-1-0566.
Opinions, interpretations, conclusions and recommendations are
those of the author and are not necessarily endorsed by the
Department of Defense.
About Alivio
Alivio Therapeutics, Inc., an affiliate of PureTech Health
(PRTC.L), is pioneering targeted disease immunomodulation as a
novel strategy to treat a range of chronic and acute inflammatory
disorders. Targeted disease immunomodulation involves tuning the
immune system exclusively at the site of disease in the body, with
minimal impact on the rest of the immune system. This long
sought-after approach has potential to treat a range of chronic and
acute inflammatory disorders including ones that would otherwise be
difficult to treat. Based on the research of Dr Karp and Dr Robert
Langer, David H Koch Institute Professor at MIT, Alivio's
proprietary inflammation-targeting platform is designed to
administer therapeutics to the sites of inflammation, while sparing
healthy tissue. The technology is also engineered to respond
dynamically to inflammation, releasing the entrapped therapeutics
based on the degree of inflammation present. Alivio's pipeline
includes candidates for interstitial cystitis/bladder pain syndrome
(IC/BPS), pouchitis, and inflammatory bowel disease (IBD).
The technology platform has been published in peer-reviewed
journals, including in Science Translational Medicine and Nature
Communications, and the technology is the first of its kind to
demonstrate reproducible targeting of immunomodulatory compounds to
inflamed tissue in preclinical models, having been validated in
multiple labs and in ten different preclinical models of
inflammation where the inflammation occurred in different parts of
the body (e.g., the GI system, the bladder, joints, skin, etc.).
The technology could potentially be used with a variety of
medications (e.g., small molecules, biologics, and nucleic acids)
both independently or in combination and is designed to be
administered orally or via other routes. With this platform, Alivio
aims to address the dozens of conditions where inflammation is a
central part of the underlying disease pathology, but where
targeted and effective treatment options are lacking.
Alivio is developing its therapies in collaboration with several
of the world's leading experts in biomaterials and immunology.
Expert advisors include: Jeffrey Karp, PhD, Professor of Medicine
at Brigham and Women's Hospital and Alivio co-founder; Robert
Langer, ScD, Alivio co-founder and Non-Executive Director at
PureTech Health and David H Koch Institute Professor at MIT;
Michael B Brenner, MD, Chief of the Division of Rheumatology,
Immunology and Allergy at BWH; Ulrich H von Andrian, MD, PhD,
Mallinckrodt Professor of Immunopathology at Harvard Medical
School; and Ralph Weissleder, MD, PhD, Director of the Center for
Systems Biology at Massachusetts General Hospital.
About PureTech Health
PureTech Health (LSE: PRTC) is an advanced biopharmaceutical
company developing novel medicines for dysfunctions of the
Brain-Immune-Gut (BIG) Axis. The Company has developed deep
insights into the connection between the individual components of
these systems and the resulting role in many chronic diseases,
which have proven resistant to established therapeutic approaches.
By harnessing this emerging field of human biology, PureTech Health
is developing new categories of medicines with the potential to
have great impact on people with serious diseases.
PureTech Health is advancing a rich pipeline of innovative
therapies across two divisions: the Affiliates division and the
Internal division. Its Affiliates division includes two product
candidates that have been filed with the US Food and Drug
Administration (FDA) for review and several other novel clinical
and pre-clinical programmes. These affiliates are developing
ground-breaking platforms and therapeutic candidates in
collaboration with some of the world's leading experts.
PureTech's Internal division is advancing a pipeline fuelled by
recent discoveries in lymphatics and immune cell trafficking to
modulate disease in a tissue-specific manner. These programmes
leverage the transport and biodistribution of various immune system
components for the targeted treatment of diseases with major unmet
needs, including cancers, autoimmune diseases, and neuroimmune
disorders.
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, 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 Tom Donovan
+1 617 651 3156 +44 (0) 20 3727 1000 +1 857 559 3397
amt@puretechhealth.com ben.atwell@FTIconsulting.com tom@tenbridgecommunications.com
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END
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