TIDMPRTC
RNS Number : 6889V
PureTech Health PLC
25 July 2018
25 July 2018
PureTech Health plc
PureTech Health Affiliate resTORbio Announces Positive Topline
Results in Phase 2b Trial of RTB101
PureTech Health plc (LSE: PRTC) ("PureTech Health"), a
clinical-stage biopharmaceutical company developing novel medicines
for dysfunctions of the Brain-Immune-Gut (BIG), today announced
that its independent affiliate, resTORbio (NASDAQ: TORC), reported
positive topline results from its Phase 2b clinical study. Details
are provided below in the resTORbio press release, and a conference
call to discuss the results will be hosted today at 8.30 EDT /
13.30 BST. To participate in the conference call, please dial (629)
228-0720 and refer to conference ID 3181638. A live webcast of the
call can be accessed in the "Investors" section of the resTORbio
website at www.restorbio.com. An archived webcast recording will be
available on the resTORbio website beginning approximately two
hours after the call.
Joe Bolen, PhD, Chief Scientific Officer of PureTech Health
commented: "resTORbio's proprietary TORC1 inhibitor, RTB101, has
significantly reduced the percentage of elderly individuals with
respiratory tract infections (RTIs) across two Phase 2 clinical
studies at the 10 mg once daily dose. We are very pleased with
these positive results and believe RTB101 may be a promising new
treatment for elderly individuals who are at high risk of
RTI-associated morbidity and mortality."
The full text announcement from resTORbio is as follows:
resTORbio Announces Positive Topline Results in Phase 2b Trial
of RTB101
-- Statistically significant and clinically meaningful 30.6%
reduction in the percentage of patients with one or more
laboratory-confirmed respiratory tract infections (RTIs), the
primary endpoint of the trial, in the RTB101 10 mg once daily
cohort compared to the placebo cohort --
-- Statistically significant 68.4% reduction in the incidence of
laboratory-confirmed RTIs in the pre-specified analysis of asthma
patients 65 years and older treated with RTB101 10 mg once daily
--
-- Statistically significant 66.7% reduction in the incidence of
laboratory-confirmed RTIs in the pre-specified analysis of patients
85 years and older treated with RTB101 10 mg once daily --
--All doses were well-tolerated; RTB101 10 mg once daily had a
comparable safety profile to placebo--
--The Phase 2b trial successfully identified a dose and patient
populations with high unmet need for upcoming pivotal trials --
-- Conference call 8:30 AM Eastern Time today --
BOSTON, July 25, 2018 -- resTORbio, Inc. (Nasdaq: TORC) today
announced positive topline results from its dose-ranging Phase 2b
clinical trial that enrolled 652 elderly patients at increased risk
of morbidity and mortality associated with respiratory tract
infections (RTIs). In this trial, RTB101, an oral, selective, and
potent inhibitor of target of rapamycin complex 1 (TORC1),
demonstrated a statistically significant and clinically meaningful
reduction in the percentage of patients with one or more
laboratory-confirmed RTIs during the 16-week treatment period
compared to placebo, the primary endpoint of the study, with the 10
mg once daily dose. Greater TORC1 inhibition with RTB101 10 mg in
combination with everolimus 0.1 mg did not meet the primary
endpoint, suggesting that that less TORC1 inhibition with RTB101 10
mg once daily may have greater benefit in high-risk elderly
patients.
"This Phase 2b has successfully defined a dose, RTB101 10 mg
once daily, to be evaluated in future pivotal studies. That dose
led to a statistically significant decrease in the incidence of
laboratory-confirmed RTIs and was well-tolerated in the high-risk
elderly patients enrolled in the Phase 2b study. We have also
identified patient populations that were particularly high
responders," said Joan Mannick, M.D., Co-Founder and Chief Medical
Officer of resTORbio. "We believe the findings of this trial
provide us with a clear path forward for pursuing a pivotal program
for RTB101 to reduce the incidence of RTIs in high-risk elderly
patients. We look forward to working closely with the U.S. Food and
Drug Administration (FDA) and other regulatory agencies on this
program."
"The majority of RTIs requiring hospitalizations in the very
elderly and the majority of asthma exacerbations are caused by
viruses for which there are currently no approved therapies," said
Professor Sebastian Johnston, Professor of Respiratory Medicine and
Allergy at the National Heart and Lung Institute, Imperial College
London. "The magnitude of reduction in the incidence of
laboratory-confirmed RTIs observed with RTB101 suggests that, if
successfully developed and approved, RTB101 may be a new promising
treatment for the very elderly and elderly patients with asthma who
are at high risk of morbidity and mortality associated with
RTIs."
"The primary endpoint of this Phase 2b study, the percentage of
patients with laboratory-confirmed RTIs, was chosen based on
feedback from the FDA, and we look forward to discussing these
results at our end of Phase 2 meeting with the agency," said Chen
Schor, Co-Founder, President and CEO of resTORbio. "RTIs are the
fourth leading cause of hospitalization in patients 65 years and
older, and the second leading cause of hospitalization in patients
85 years and older in the U.S. We are committed to helping the
millions of elderly patients at high risk of morbidity and
mortality due to RTIs."
The Phase 2b trial was a two-part, randomized, double-blind,
placebo-controlled clinical trial conducted during the winter cold
and flu season in the southern hemisphere (Part 1) and northern
hemisphere (Part 2). Patients enrolled were those at increased risk
of morbidity and mortality from RTIs including patients who were:
(i) 85 years of age or older, or (ii) 65 years of age or older with
asthma, type 2 diabetes mellitus (T2DM), chronic obstructive
pulmonary disease (COPD), or current smokers. The doses
investigated in Part 1 were RTB101 5 mg and RTB101 10 mg once
daily. The doses investigated in Part 2 were RTB101 10 mg once
daily, RTB101 10 mg twice daily and RTB101 10 mg in combination
with everolimus 0.1 mg once daily.
The following was observed in an analysis of the primary
endpoint:
-- A 30.6% decrease relative to placebo in the percentage of all
patients treated with RTB101 10 mg once daily who developed one or
more laboratory-confirmed RTIs (p=0.026)
-- A 20.6% decrease relative to placebo in the percentage of all
patients treated with RTB101 5 mg once daily who developed one or
more laboratory-confirmed RTIs (p=0.108)
-- No decrease relative to placebo in the percentage of patients
treated with either RTB101 10 mg twice daily or the combination of
RTB101 10 mg + everolimus 0.1 mg once daily who developed one or
more laboratory-confirmed RTIs, suggesting that less TORC1
inhibition with RTB101 10 mg once daily may have greater benefit in
high-risk elderly patients
To better understand the activity observed in the RTB101 10 mg
once daily cohort, a pre-specified analysis of each patient
subgroup enrolled in the study was conducted. The following
decreases in the percentage of patients with laboratory-confirmed
RTIs were observed in the RTB101 10 mg once daily cohort as
compared to the placebo cohort:
-- A 68.4% decrease in all asthma patients (p=0.0002)
-- A 66.7% decrease in all patients 85 years of age and older (p=0.007)
-- A 26.9% decrease in all T2DM patients (p=0.020)
-- No decrease was observed in either COPD patients or current
smokers; a 42.0% decrease in all patients was observed when
excluding patients with COPD (p=0.002) and a 43.9% decrease in all
patients was observed when excluding current smokers (p=0.001)
All doses were observed to be well-tolerated. Data from the
RTB101 10 mg once daily cohort are as follows: Adverse events (AEs)
were balanced between the RTB101 10 mg once daily and placebo
treatment groups. 4.5% of subjects in the RTB101 10 mg once daily
cohort and 7.2% of subjects in the placebo cohort had a serious
adverse event, none of which were considered related to study drug.
4.5% of subjects in the RTB101 10 mg once daily cohort and 6.1% of
subjects in the placebo cohort discontinued study drug due to an
AE. All AEs were mild or moderate except for 11 severe AEs in the
RTB101 10 mg once daily cohort and 22 severe AEs in the placebo
cohort.
This Phase 2b is the second study in which RTB101 10 mg once
daily was observed to be well-tolerated and reduce the incidence of
RTIs in the elderly. Together, these studies enrolled more than 900
elderly people.
Conference Call and Webcast Information
resTORbio management will host a conference call today at 8:30
a.m. ET to discuss the results of the Phase 2b trial. To
participate in the conference call, please dial (877) 356-9149
(domestic) or (629) 228-0720 (international) and refer to
conference ID 3181638. A live webcast of the call can be accessed
in the "Investors" section of the Company's website at
www.restorbio.com. An archived webcast recording will be available
on the resTORbio website beginning approximately two hours after
the call.
Phase 2b Trial Design
The purpose of the exploratory dose-finding, randomized,
double-blind, placebo-controlled, multi-center Phase 2b clinical
trial was to determine if RTB101 alone or in combination with
everolimus decreased the incidence of RTIs in high-risk elderly
patients, as well as to evaluate safety and tolerability alone or
in combination with everolimus, to support dose selection for
pivotal trials.
The study enrolled 652 patients at increased risk of morbidity
and mortality from RTIs including patients who were: (i) 85 years
of age or older, or (ii) 65 years of age or older with asthma,
T2DM, COPD, or current smokers. The study consisted of two parts.
Part 1 was conducted during the winter cold and flu season in the
southern hemisphere and 179 elderly patients were randomized to
receive either placebo, RTB101 5 mg or RTB101 10 mg once daily. At
the end of Part 1, an interim analysis was conducted by an
unblinded data monitoring committee who selected the RTB101 10 mg
dose to move forward into Part 2 of the study. Part 2 was conducted
during the winter cold and flu season in the northern hemisphere
and 473 elderly patients were randomized to receive either placebo,
RTB101 10 mg once daily, RTB101 10 mg twice daily, or RTB101 10 mg
in combination with everolimus 0.1 mg once daily. All patients were
treated with study drug for 16 weeks, and then were followed for an
additional eight weeks off study drug.
The primary endpoint of the trial was a reduction, as compared
to placebo, in the percentage of patients with one or more
laboratory-confirmed RTIs during the 16 weeks of study drug
treatment. A pre-specified exploratory endpoint was a reduction, as
compared to placebo, in the percentage of patients with one or more
laboratory-confirmed RTIs in each of the patient subgroups (>=
85 years of age, >= 65 years of age with asthma, COPD, T2DM, or
current smokers).
Additional information about the study [NCT03373903] can be
obtained at www.ClinicalTrials.gov.
About Respiratory Tract Infections
The reduced ability of the aging immune system to effectively
detect and fight infections results in increased susceptibility of
the elderly to RTIs. In the U.S., RTIs are the fourth leading cause
of hospitalizations and seventh leading cause of death in people
age 65 years and older. Additionally, the majority of asthma
exacerbations are caused by RTIs, and the majority of RTIs are
caused by viruses for which there are no currently approved
therapies.
A survey was conducted by resTORbio of 100 physicians in the
U.S. that treat approximately 25,000 patients aged 65 years or
older monthly. Depending on their specialty, the physcians surveyed
estimated that they would prescribe a therapeutic that reduced the
incidence of laboratory-confirmed RTIs by 25% to approximately
30-50% of their high-risk elderly patients. Data from market
surveys may not predict actual prescribing behavior should RTB101
receive regulatory approval.
About RTB101
RTB101 is an oral, selective, and potent inhibitor of TORC1.
RTB101 inhibits the phosphorylation of multiple targets downstream
of TORC1. Inhibition of TORC1 has been observed to extend lifespan
and healthspan in aging preclinical species and to enhance immune,
cardiac and neurologic functions, suggesting potential benefits in
several aging-related diseases.
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 program is selectively targeting
TORC1, an evolutionarily conserved pathway that contributes to the
decline in function of multiple organ systems, including the
immune, cardiovascular and central nervous systems.
Forward Looking Statements
This press release contains forward-looking statements that are
made pursuant to the safe harbor provisions of the federal
securities laws. Investors are cautioned that statements in this
press release which are not strictly historical statements,
including, without limitation, express or implied statements or
guidance regarding our plans to develop and commercialize RTB101
alone or in combination with everolimus, including the therapeutic
potential and clinical benefits thereof, and the potential patient
populations that may be addressed by our product candidates, our
ongoing and future clinical trials for RTB101 alone or in
combination with everolimus, including the timing of the initiation
and anticipated results of these trials, as well as the intended
regulatory path for our product candidates and interactions with
regulatory authorities, constitute forward-looking statements
identified by words like "believe," "expect," "may," "will,"
"should," "seek," "anticipate," or "could" and similar expressions.
Such forward-looking statements are subject to a number of risks
and uncertainties that could cause actual results to differ
materially from those anticipated, including, without limitation,
risks associated with: the delay of any planned clinical trials
and/or development of RTB101, either alone or in combination with
everolimus; our ability to successfully demonstrate the efficacy
and safety of our lead product candidate; the clinical results for
our lead product candidate which may not support further
development of additional indications; and obtaining, maintaining
and protecting our intellectual property; as well as those risks
more fully discussed in the section entitled "Risk Factors" in the
Annual Report on Form 10-K filed by resTORbio, Inc. with the
Securities and Exchange Commission, as well as discussions of
potential risks, uncertainties, and other important factors in our
subsequent filings with the Securities and Exchange Commission. In
addition, any forward-looking statements represent our views only
as of today and should not be relied upon as representing its views
as of any subsequent date. resTORbio explicitly disclaims any
obligation to update any forward-looking statements.
About PureTech Health
PureTech Health (LSE: PRTC) is an advanced, clinical-stage
biopharmaceutical company developing novel medicines for
dysfunctions of the Brain-Immune-Gut (BIG). The Company has
developed deep insight into the connection between these systems
and the resulting role in many chronic diseases, which represent
the majority of healthcare spend and have proven resistant to
established therapeutic approaches. By harnessing this emerging
field of human biology, PureTech Health has developed 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. Its Affiliates division includes
two product candidates that are preparing for potential regulatory
approval in the United States and Europe and a number of clinical
and pre-clinical programmes. These affiliates have developed
ground-breaking platforms and therapeutic candidates in
collaboration with some of the world's leading scientific
experts.
PureTech's Internal division (Ariya) is advancing a pipeline
fuelled by recent discoveries in lymphatics and immune cell
trafficking to modulate disease in a tissue-specific manner. These
programmes build on a new understanding of the transport and
biodistribution of various immune system components in order to
develop targeted therapies for diseases with major unmet needs
including cancer and autoimmune and neuroimmune disorders. One of
these programs, which is focused on the oral administration of
nucleic acids and other biologics using milk exosomes, is being
advanced in collaboration with Roche for the potential application
across their antisense oligonucleotides platform.
For more information, visit www.puretechhealth.com or connect
with us on Twitter @puretechh.
Ownership Information
PureTech Health owns 9,800,396 shares of resTORbio, which is
equal to approximately 34.9% of the outstanding shares of
resTORbio.
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.
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014.
Contact:
Investors EU media
Allison Mead Talbot Ben Atwell, Rob
+1 617 651 3156 Winder
amt@puretechhealth.com +44 (0) 20 3727
1000
ben.atwell@FTIconsulting.com
This information is provided by RNS, the news service of the
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END
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