TIDMPRTC
RNS Number : 6210T
PureTech Health PLC
15 November 2019
15 November 2019
PureTech Health plc
PureTech's Independent Affiliate resTORbio Announces That the
Phase 3 PROTECTOR 1 Trial of RTB101 in Clinically Symptomatic
Respiratory Illness Did Not Meet the Primary Endpoint
PureTech Health plc (LSE: PRTC) ("PureTech") notes that
resTORbio, Inc., (Nasdaq: TORC), an independent affiliate of
PureTech, today announced that top line data from the PROTECTOR 1
Phase 3 study, evaluating the safety and efficacy of RTB101 in
preventing clinically symptomatic respiratory illness (CSRI) in
adults age 65 and older, did not meet its primary endpoint, and
that it has stopped the development of RTB101 in this indication.
The company will continue development of RTB101 in other
aging-related diseases, including Parkinson's disease, and it
remains well funded with $117.3 million in cash, cash equivalents
and marketable securities as of September 30, 2019. resTORbio
management will host a conference call at 8:00 a.m. EST today.
The full text of the announcement from resTORbio is as
follows:
resTORbio Announces That the Phase 3 PROTECTOR 1 Trial of RTB101
in Clinically Symptomatic Respiratory Illness Did Not Meet the
Primary Endpoint
Company stops further development of clinically symptomatic
respiratory illness indication but continues development of RTB101
in other aging-related diseases, including Parkinson's disease
Company remains well funded with $117.3 million in cash, cash
equivalents and marketable securities as of September 30, 2019
Management to host conference call at 8:00 a.m. EST today
BOSTON, Nov. 15, 2019 -- resTORbio, Inc., (Nasdaq: TORC), a
clinical-stage biopharmaceutical company developing innovative
medicines that target the biology of aging to prevent or treat
aging-related diseases, today announced that top line data from the
PROTECTOR 1 Phase 3 study, evaluating the safety and efficacy of
RTB101 in preventing clinically symptomatic respiratory illness
(CSRI) in adults age 65 and older, did not meet its primary
endpoint, and that it has stopped the development of RTB101 in this
indication. RTB101 is an oral, selective, and potent TORC1
inhibitor.
"While we are disappointed in these results, there are extensive
preclinical data supporting the potential therapeutic benefit of
TORC1 inhibition in multiple aging-related diseases, including
Parkinson's disease, for which we have an active Phase 1b/2a trial
of RTB101 alone or in combination with sirolimus," said Chen Schor,
co-founder, president and CEO of resTORbio. "Multiple pre-clinical
models have demonstrated that inhibition of TORC1 decreases protein
and lipid synthesis, increases lysosomal biogenesis and stimulates
the clearance of misfolded protein aggregates, such as toxic
synucleins, that cause neuronal toxicity in Parkinson's disease. We
remain committed to exploring the potential benefits of TORC1
inhibition in patients, and we look forward to the data from our
Parkinson's disease trial, which we expect in mid-2020."
The PROTECTOR 1 Phase 3 trial was a randomized, double-blind,
placebo-controlled clinical trial that evaluated 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 individuals with chronic obstructive
pulmonary disease. The primary endpoint of the trial was the
reduction in the percentage of subjects with clinically symptomatic
respiratory illness, defined as illness associated with a
respiratory tract infection, or RTI, based on prespecified
diagnostic criteria, with or without laboratory confirmation of a
pathogen. The PROTECTOR 1 trial included 1024 patients who were
randomized 1:1 to receive RTB101 or placebo administered once daily
for 16 weeks. In an analysis of the primary endpoint, the odds of
experiencing a CSRI were 0.44 in the placebo cohort and 0.46 in the
RTB101 cohort (odds ratio 1.07, p=0.65). The Company plans to
conduct detailed analyses of the PROTECTOR 1 study, including
additional data on safety and secondary and exploratory endpoints,
which are not available at this time, with the goal of gaining
insights that may explain the difference in RTB101 activity
observed in PROTECTOR 1 as compared to prior Phase 2 studies.
Conference Call Information
Management will host a conference call at 8:00 a.m. EST today to
review these pivotal results and provide an update on additional
clinical development plans for RTB101. The conference call can be
accessed by dialing (877) 356-9149 or (629)-228-0720
(international) and referencing conference ID 6066628 prior to the
start of the call. The call will also be webcast via the Internet
and will be available under the "Investors & Media" section of
the resTORbio website, www.restorbio.com.
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 preclinical models of aging-related diseases
including Parkinson's disease.
About Parkinson's Disease in Older Adults
Parkinson's disease, or PD, is a progressive neurodegenerative
disease that affects approximately 7.5 million people worldwide.
The incidence of PD increases rapidly in people 60 years of age and
older, with a mean age at diagnosis of 70.5 years.
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
candidate, RTB101, selectively inhibits TORC1, an evolutionarily
conserved pathway that contributes to the decline in function of
multiple organ systems, including neurologic, immune and cardiac
function. 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, our proposed timing and anticipated
results of our Phase 1b/2a clinical trial of RTB101 alone or in
combination with sirolimus in patients with mild to severe
Parkinson's disease; 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;
our expectations on the potential patient populations that may be
addressed by our product candidates; our ability to replicate
results achieved in our clinical trials in any future trials; our
cash position and expected cash runway; our expectations regarding
our uses of capital, constitute forward-looking statements
identified by words such as, but not limited to, "believe,"
"expect," "may," "will," "should," "seek," "anticipate," or "could"
and similar words or expressions.
Any forward-looking statements in this statement are based on
management's current expectations of future events and 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 ongoing Phase 1b/2a clinical trial of RTB101 alone or
in combination with sirolimus in Parkinson's disease; the timing
and anticipated results of our clinical trials; the risk that the
results of our clinical trials will be predictive of future results
in connection with future 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
are neither historical facts nor assurances of future performance.
Instead, they represent our beliefs, expectations, assumptions and
views only as of today and should not be relied upon as
representing our beliefs, expectations, assumptions and views as of
any subsequent date. resTORbio explicitly disclaims any obligation
to update any forward-looking statements. No representations or
warranties (expressed or implied) are made about the accuracy of
any such forward-looking statements.
About PureTech Health
PureTech is a clinical stage biotechnology 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 affiliates, is comprised of 24 product
candidates and one product that has been cleared by the US Food and
Drug Administration (FDA). 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, 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
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
MSCCKPDQBBDDCDD
(END) Dow Jones Newswires
November 15, 2019 07:51 ET (12:51 GMT)
Puretech Health (LSE:PRTC)
Gráfica de Acción Histórica
De Mar 2024 a Abr 2024
Puretech Health (LSE:PRTC)
Gráfica de Acción Histórica
De Abr 2023 a Abr 2024
