resTORbio Announces Delay of its Ongoing Phase 1b/2a trial of RTB101 in Patients with Parkinson’s Disease Due to COVID-19 L...
April 03 2020 - 8:00AM
resTORbio (Nasdaq: TORC) today announced that it will postpone
enrollment in the fifth cohort of its ongoing Phase 1b/2a trial of
RTB101, an orally administered, small molecule product candidate
that is a potent inhibitor of target of rapamycin complex 1
(TORC1), alone or in combination with sirolimus, in Parkinson’s
disease (PD). The trial is being conducted at clinical sites in New
Zealand and the enrollment delay is a consequence of the COVID-19
level 4 alert in New Zealand, where all non-essential services have
been closed and people have been instructed to stay home.
“We want to ensure the safety of our clinical trial
participants, many of whom are older adults at high risk of
COVID-19 morbidity and mortality. Therefore, we have postponed
enrollment in the fifth cohort of our ongoing Phase 1b/2a clinical
trial of RTB101 in patients with PD. Enrollment in the first four
cohorts has been completed, and we are actively monitoring the
situation in New Zealand so that we may resume our clinical
activity when the time is appropriate,” said Dr. Joan Mannick,
Co-Founder and Chief Medical Officer of resTORbio. “We remain
committed to exploring the potential benefits of TORC1 inhibition
in PD patients, and we look forward to the data from the four
completed cohorts.”
Phase 1b/2a Trial of RTB101 alone and In combination
with sirolimus in Parkinson’s disease study resultsThe
multicenter, 2:1 randomized, double-blind, placebo-controlled Phase
1b/2a trial is evaluating the safety and tolerability of RTB101
alone or in combination with escalating doses of sirolimus (2 mg, 4
mg and 6 mg) once weekly for 4 weeks in patients with Parkinson’s
disease. To date, patients have been enrolled in four cohorts and
dosed once weekly with 300 mg of RTB101 alone, 2 mg of sirolimus
alone, a combination of 300 mg RTB101 and 2 mg of sirolimus, or a
combination of 300 mg RTB101 and 4 mg of sirolimus. Results of the
interim study analysis after the first 3 cohorts indicated that all
3 dosing regimens were well tolerated and RTB101 300 mg once weekly
was observed to cross the blood brain barrier. The concentrations
of RTB101 in cerebrospinal fluid (CSF) in subjects dosed with
RTB101 300 mg once weekly monotherapy were higher than expected and
based on preclinical models, have the potential to induce autophagy
in the brain. Sirolimus at the dose of 2 mg, alone or in
combination with RTB101, was not detected in the CSF. Data from the
first three cohorts in the study suggest that the concentrations of
RTB101 observed in the CSF four hours after dosing were highest
when RTB101 was given as a monotherapy. Enrollment and dosing of
the RTB101 300 mg in combination with sirolimus 4 mg once weekly
cohort has been completed.
About Parkinson’s DiseaseParkinson’s disease
(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. Inhibition of TORC1 has been
shown in multiple preclinical models to ameliorate
neurodegenerative diseases including Parkinson’s disease. TORC1
inhibition with RTB101 alone or in combination with sirolimus, may
provide a therapeutic benefit to PD patients by ameliorating
levodopa-induced dyskinesia and/or by inducing autophagy which
leads to the breakdown of protein aggregates and improved neuronal
survival.
About RTB101RTB101 is an oral, selective, and
potent TORC1 inhibitor product candidate that 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 improve the function of aging
organ systems, including neurologic function, suggesting potential
benefits in several aging-related diseases.
About resTORbioresTORbio, Inc. is a
clinical-stage biopharmaceutical company developing innovative
medicines that target the biology of aging to treat aging-related
diseases. resTORbio’s lead program selectively inhibits TORC1, an
evolutionarily conserved pathway that contributes to the decline in
function of aging organ systems, including neurologic function.
Learn more about resTORbio, Inc. at www.resTORbio.com.
Forward Looking StatementsThis
press release contains “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995,
including, but not limited to, statements regarding: our
expectations of the potential impact of COVID-19 on strategy,
future operations, and the timing of its clinical trials and
specifically the enrollment of the fifth cohort in our ongoing
Phase 1b/2a trial; the safety, efficacy and regulatory and
clinical progress of our product candidates, including RTB101 alone
or in combination with sirolimus. 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 Phase 1b/2a clinical
trial of RTB101 in combination with sirolimus in Parkinson’s
disease, our plans to develop RTB101 alone or in combination with
rapalogs, 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 our ability to replicate results
achieved in our clinical trials in any future trials, constitute
forward-looking statements. The use of words such as, but not
limited to, “believe,” “expect,” “estimate,” “project,” “intend,”
“future,” “potential,” “continue,” “may,” “might,” “plan,” “will,”
“should,” “seek,” “anticipate,” or “could” and other similar words
or expressions are intended to identify forward-looking
statements. Forward-looking statements are neither historical
facts nor assurances of future performance. Instead, they are based
on our current beliefs, expectations and assumptions regarding the
future of our business, future plans and strategies, our clinical
results and other future conditions. New risks and uncertainties
may emerge from time to time, and it is not possible to predict all
risks and uncertainties. No representations or warranties
(expressed or implied) are made about the accuracy of any such
forward-looking statements.
Such forward-looking statements are subject to a number of
material risks and uncertainties that are 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. Any
forward-looking statement speaks only as of the date on which it
was made. Neither we, nor our affiliates, advisors or
representatives, undertake any obligation to publicly update or
revise any forward-looking statement, whether as result of new
information, future events or otherwise, except as required by
law.
Investor ContactLauren StivalStern Investor
Relations, Inc.212-362-1200lauren.stival@sternir.com
Media ContactLauren Arnold MacDougall
781-235-3060 larnold@macbiocom.com
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