TIDMPRTC
PureTech Health PLC
12 July 2018
12 July 2018
PureTech Health plc
PureTech's resTORbio Publishes Results from Phase 2a Study in
Journal Science Translational Medicine
Newly published data demonstrated significant reduction in
incidence of all infections, including respiratory tract
infections, in people aged 65 and older and improvement in immune
function
PureTech Health plc (LSE: PRTC) ("PureTech Health"), a
clinical-stage biopharmaceutical company developing novel medicines
focused on the Brain-Immune-Gut (BIG) Axis, today notes that
resTORbio, Inc. (NASDAQ: TORC), an affiliate of PureTech Health,
has published the results from a Phase 2a study of its target of
rapamycin complex 1 (TORC1) programme in a leading scientific
journal, Science Translational Medicine. The newly published
results from the Phase 2a study, which was completed prior to
PureTech's founding of resTORbio, showed that inhibition of TORC1
with RTB101 alone or in combination with everolimus improved immune
function and reduced the incidence of all infections, including
respiratory tract infections (RTIs), in people aged 65 and older.
Respiratory tract infections are the 4(th) leading cause of
hospitalisation and the 7(th) leading cause of death in people 65
years of age and over.
Topline results from resTORbio's Phase 2b study are expected in
the third quarter of 2018 and will evaluate the effectiveness of
RTB101 alone or in combination with everolimus in reducing the
incidence of RTIs in elderly patients at increased risk of
morbidity and mortality related to RTIs.
Joe Bolen, PhD, Chief Scientific Officer of PureTech Health,
said: "These newly published results demonstrate the therapeutic
potential and favourable safety profile of resTORbio's TORC1
programme as a potential new class of immunotherapy. When we
co-founded resTORbio, these results, as well as data from other
studies, were instrumental in our decision to advance RTB101 alone
or in combination with everolimus into a Phase 2b clinical trial in
respiratory tract infections, and we look forward to the results of
that study."
The full text of the announcement from resTORbio is as
follows:
resTORbio Announces Science Translational Medicine Publication
of Phase 2a Data Showing Improvement in Immune Function and
Decreased Infection Rates in People Aged 65 Years and Older
- resTORbio's TORC1 inhibitors enhanced the function of the
aging immune system and were associated with a statistically
significant decrease in the incidence of all infections, including
respiratory tract infections, in older people
- Respiratory tract infections are the 4(th) leading cause of
hospitalisation and the 7(th) leading cause of death in people 65
years of age and older
BOSTON, July 11, 2018 -- resTORbio (Nasdaq: TORC) today
announced newly published data from a Phase 2a clinical trial
demonstrating that target of rapamycin complex 1 (TORC1) inhibitor
treatment improved immune function and decreased incidence of all
infections, including respiratory tract infections (RTIs), in
people aged 65 years and older. RTIs in particular are a
significant health risk for the elderly with life-threatening
consequences and few treatment options. Data were published in the
July 11, 2018 online edition of the journal Science Translational
Medicine.
"Inhibition of TORC1 has extended both lifespan and healthspan
in multiple pre-clinical species," said Joan Mannick, MD,
Co-Founder and Chief Medical Officer of resTORbio. "The results of
this Phase 2a trial raise the possibility that TORC1 inhibition
also has health benefits in older humans. In the Phase 2a trial,
TORC1 inhibitor treatment was associated with a clinically
meaningful reduction in the incidence of infections in people aged
65 years and older and an enhancement in the function of the aging
immune system as assessed by influenza vaccination response and
antiviral gene expression. The results need to be validated in
additional clinical trials, but may have broad implications for the
treatment of diseases of aging that we are actively investigating
with our TORC1 inhibitor programme."
The data for this publication were gathered in a randomised,
double-blinded, placebo-controlled Phase 2a study of 264 elderly
volunteers at least 65 years of age without unstable medical
conditions. Subjects were treated for 6 weeks with study drug and
after a 2-week drug-free interval, were given a seasonal influenza
vaccine. The incidence of infections was assessed for one year
after initiation of study drug treatment. In the RTB101 monotherapy
and RTB101+everolimus combination treatment arms, statistically
significant and clinically meaningful reductions in the annual rate
of infections of 33% (p=0.008) and 38% (p=0.001), respectively,
compared to placebo, were observed. In addition, both RTB101
monotherapy and the RTB101+everolimus combination therapy were
observed to reduce the incidence of RTIs at one year by 42%
(p=0.006) and 36% (p=0.01), respectively. The combination of
RTB101+everolimus was also observed to significantly enhance the
response to influenza vaccination and upregulated the expression of
critical antiviral genes that play a key role in enabling the
immune system to protect the elderly from respiratory tract
infections.
RTIs are the fourth leading cause of hospitalisations and the
seventh leading cause of death in people aged 65 years and older in
the United States. Moreover, the majority of RTIs in the elderly
are caused by viruses for which there are currently no approved
therapies. resTORbio's TORC1 inhibitor programme has the potential,
if successfully developed and approved, to be a new class of
immunotherapy that enhances the function of the aging immune system
to fight infectious pathogens including viruses, and thereby reduce
the incidence of respiratory tract infections.
Based on the results of the Phase 2a study, resTORbio is
conducting a Phase 2b clinical trial to further investigate the
potential benefits of RTB101 alone and in combination with
everolimus in aging-related diseases. In the ongoing Phase 2b
study, doses of RTB101 alone and in combination with everolimus are
being evaluated as an immunotherapy to decrease the incidence of
RTIs in older people at increased risk of morbidity and mortality
from RTIs (defined as age 85 and older and age 65 and older with
comorbidities). Dosing has been completed in the Phase 2b study and
16-week topline data is expected to be reported in the third
quarter of 2018.
About RTB101
RTB101 is an oral, selective and potent inhibitor of target of
rapamycin complex 1 (TORC1). RTB101 inhibits the phosphorylation of
multiple targets downstream of TORC1. The combination of RTB101
with everolimus is synergistic and results in broader TORC1
inhibition. Inhibition of TORC1 has been observed to extend
lifespan and healthspan in aging pre-clinical species and enhances
immune, cardiac and neurologic function, suggesting potential
benefits in several diseases of age.
About resTORbio
resTORbio, Inc. is a clinical-stage biopharmaceutical company
targeting TORC1 and other biological pathways that regulate aging
to develop innovative medicines with the potential to extend
healthy lifespan. resTORbio's lead programme is targeting the
selective inhibition of TORC1, an evolutionarily conserved pathway
that contributes to the decline in function of multiple organ
systems, including the immune, cardiovascular and central nervous
systems.
About PureTech Health
PureTech Health (PRTC.L) is an advanced, clinical-stage
biopharmaceutical company developing novel medicines targeting
serious diseases that result from dysfunctions in the nervous,
immune, and gastrointestinal systems (brain-immune-gut or the "BIG"
axis), which together represent the adaptive human systems.
PureTech Health is at the forefront of understanding and addressing
the biological processes and crosstalk associated with the BIG
axis. By harnessing this emerging field of human biology, PureTech
Health is pioneering new categories of medicine with the potential
to have great impact on people with serious diseases. PureTech
Health is advancing a rich pipeline of innovative therapies that
includes two pivotal stage programmes, multiple human
proof-of-concept studies and a number of early clinical and
pre-clinical programmes. PureTech's research and development
pipeline has been advanced in collaboration with some of the
world's leading scientific experts, who along with PureTech's team
of biopharma pioneers, entrepreneurs and seasoned Board, identify,
invent, and clinically de-risk new medicines. With this experienced
team pursuing cutting edge science, PureTech Health is building the
biopharma company of the future focused on improving and extending
the lives of people with serious disease. 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
Allison Mead Talbot Ben Atwell, Rob Winder
+1 617 651 3156 +44 (0) 20 3727 1000
amt@puretechhealth.com ben.atwell@FTIconsulting.com
This information is provided by RNS, the news service of the
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END
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