resTORbio Announces Initiation of Phase 3 Clinical Program of RTB101 in Clinically Symptomatic Respiratory Illness
09 Maio 2019 - 9:00AM
resTORbio, Inc. (Nasdaq: TORC), today announced the initiation of
PROTECTOR 1, the first Phase 3 trial of RTB101, an orally
administered, small molecule, potent inhibitor of target of
rapamycin complex 1 (TORC1). The two PROTECTOR Phase 3 trials are
designed to evaluate the safety and efficacy of RTB101 for
decreasing the percent of elderly subjects with clinically
symptomatic respiratory illness, defined as illness associated with
a respiratory tract infection (RTI) based on prespecified
diagnostic criteria, with or without laboratory-confirmation of a
pathogen.
“The launch of our PROTECTOR Phase 3 program is an important
milestone for resTORbio and for the elderly population, as RTB101
has the potential to be the first immunotherapy for reducing the
incidence of illness associated with RTIs, regardless of the
causative pathogen,” said Chen Schor, Co-Founder, President and CEO
of resTORbio. “The majority of RTIs are caused by viruses, and the
results of our Phase 2 trials suggest that upregulation of innate
antiviral gene expression is a mechanism underlying the reduced
incidence of RTIs observed in elderly subjects treated with RTB101
compared to placebo. We plan to enroll approximately 2,600 subjects
in our Phase 3 trials, and believe this program will provide us
with sufficient clinical data to support the submission of a New
Drug Application (NDA) with the U.S. Food and Drug Administration
(FDA) for RTB101.”
The PROTECTOR Phase 3 program includes two randomized,
double-blinded, placebo-controlled clinical trials that will
evaluate the safety and efficacy of RTB101 10mg given once daily
for 16 weeks during winter cold and flu season to subjects 65 years
of age and older, excluding current smokers and chronic obstructive
pulmonary disease patients. The primary endpoint is the reduction
in the percentage of subjects with clinically symptomatic
respiratory illness with or without laboratory-confirmation of a
pathogen.
The PROTECTOR program incorporates feedback from both the FDA
and the European Medicines Agency on key elements of the Phase 3
trial design. PROTECTOR 1, initiated in the southern hemisphere, is
expected to enroll approximately 1,000 subjects. PROTECTOR 2, the
second Phase 3 clinical trial, is expected to begin in the northern
hemisphere in the fourth quarter of 2019 and to enroll
approximately 1,600 subjects. Based on current enrollment
expectations for the Phase 3 program, resTORbio expects top-line
data in mid-2020.
About Respiratory Tract Infections in the
Elderly
As part of the aging process, the immune system weakens and
becomes less effective at detecting and fighting infections such as
RTIs. As a result, RTIs are more likely to be of greater severity,
prolonged duration, and are more likely to be associated with
medical complications in people age 65 years and older as compared
to younger adults. In the U.S., RTIs are the fourth leading cause
of hospitalization and seventh leading cause of death in people
aged 65 and older. Given that RTIs are caused by many different
types of viruses, most of which lack effective therapies, there
remains a significant unmet medical need for an immunotherapy that
enhances the ability of the immune system to fight multiple viruses
to reduce illness associated with RTIs in the elderly.
About RTB101
RTB101 is an oral, selective, and potent TORC1 inhibitor product
candidate. TORC1 inhibition has been shown to be of
therapeutic benefit in multiple aging-related conditions in
preclinical species including immunosenescence (aging-related
decline in immune function). In two Phase 2 clinical trials
enrolling over 900 elderly people, RTB101 was observed to improve
immune function by upregulation of antiviral gene expression and to
reduce the incidence of RTIs.
About resTORbio
resTORbio, Inc. is a clinical-stage biopharmaceutical company
developing innovative medicines that target the biology of aging to
prevent or treat aging-related diseases. resTORbio’s lead program
selectively inhibits TORC1, an evolutionarily conserved pathway
that contributes to the decline in function of multiple organ
systems, including the immune, cardiovascular and central nervous
systems. Learn more about resTORbio, Inc. at www.resTORbio.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended. 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 proposed timing and trial design for
our PROTECTOR Phase 3 clinical program of RTB101, including timing
and anticipated results of this clinical trial, our future plans to
develop RTB101 alone or in combination with rapalogs, such as
everolimus or sirolimus, 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, including the timing of the
initiation and anticipated results of these trials, the continued
expansion of our pipeline into Parkinson’s disease and UTIs, the
intended regulatory path for our product candidates and
interactions with regulatory authorities, our ability to replicate
results achieved in our clinical trials in any future trials, our
cash position and expected cash runway, and our ability to fund
operations through 2020 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: our PROTECTOR Phase 3 program; our planned
Phase 3 clinical trials in RTIs and/or development of RTB101,
either alone or in combination with a rapalog, such as everolimus
or sirolimus; 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; uncertainties related to the
results of our clinical trials predictive of future results in
connection with future trials, including our Phase 3 clinical
trials; the timing and outcome of our planned interactions with
regulatory authorities; 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.
Investor ContactMichael SchaffzinStern Investor
Relations, Inc.212-362-1200michael.schaffzin@sternir.com
Media ContactEllen MurphyBiosector
2212-849-9496Ellen.Murphy@Syneoshealth.com
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