- TYME-19 is an oral synthetic bile acid that has demonstrated
broad spectrum antiviral activity as well as efficacy against
COVID-19 in preclinical studies
- Initiating proof-of-concept RESPOnD trial to investigate
TYME-19 for safety and efficacy in recently diagnosed, symptomatic
COVID-19 patients
- RESPOnD trial is being led in collaboration with investigators
from Massachusetts General Hospital and Weill Cornell Medical
Center
- Trial is targeted to begin as soon as customary clinical trial
site approvals are completed
- TYME-19 is intended to be a well-tolerated therapeutic that
could be used at earlier stages of COVID-19 infection and in future
viral outbreaks
Tyme Technologies, Inc. (NASDAQ: TYME), an emerging
biotechnology company developing cancer metabolism-based therapies
(CMBTsTM), announced a potential new approach to treating COVID-19
using a metabolic agent, TYME-19. TYME-19 is a synthetic bile acid,
a family of metabolic agents that the Company also uses in its
anticancer product, TYME-18. Because of its expertise in metabolic
therapies, the Company was able to quickly identify TYME-19 as a
potent, well characterized antiviral bile acid and has performed
preclinical experiments establishing effectiveness against
COVID-19. Bile acids have primarily been used for liver disease;
however, they represent a family of critical cellular regulators
across cardiovascular, neurologic, and metabolic systems, with some
also having antiviral properties.
TYME has partnered with physicians from Massachusetts General
Hospital and the Weill Cornell Medical Center to design a trial for
recently diagnosed, symptomatic patients. The proof-of-concept
trial is expected to start as soon as customary trial site
approvals are completed.
“There is an enormous unmet medical need for patients after
diagnosis for a safe treatment that would alleviate their symptoms
and eliminate the need for them to go to a hospital. Currently,
most of therapeutic drug development is focused on hospitalized
patients,” said Curtis L. Cetrulo, Jr., M.D. of Massachusetts
General Hospital and Harvard Medical School. “We are encouraged
with this new approach to fight COVID-19, especially one in a class
of therapies that has a well understood safety profile and
considerable research behind it. We are also hopeful that TYME-19’s
potential broad antiviral properties could help us prepare for
future outbreaks.”
In preclinical testing, TYME-19 repeatedly prevented COVID-19
viral replication without attributable cytotoxicity to the treated
cells. Previous preclinical research has also shown select bile
acids like TYME-19 have had broad antiviral activity. TYME-19 is
part of a family of metabolic agents called bile acids that have
formerly been associated with liver disease but are becoming
recognized for their potential utility to treat multiple diseases.
Bile acids are important regulators for many cellular functions
throughout the central nervous, cardiovascular and metabolic
systems1,2. TYME is a leader in the development of bile acids as
potential therapies for cancer, COVID-19 and other diseases.
TYME and its collaborating partners at Massachusetts General
Hospital and Weill Cornell Medical Center are initiating a
proof-of-concept study to evaluate TYME-19 versus placebo in newly
diagnosed, symptomatic patients with defined high-risk factors. The
trial will measure specific indicators of safety and efficacy,
including time to resolution of symptoms, changes in viral load,
rate of hospitalization and others. Positive results from the
proof-of-concept study could lead to a development program in which
TYME-19 is studied as a potential new oral treatment for patients
with COVID-19 before they require hospitalization, and/or as
prophylaxis for high-risk individuals and front-line workers.
Viruses hijack a cell’s ability to make proteins and lipids and
divert these processes to make viral proteins and lipids in order
to reproduce. Viruses accomplish this by inducing stress in the
endoplasmic reticulum (ER), where cells process proteins, which
enables the virus to remodel protein and lipid synthesis. In
preclinical testing, TYME-19 has been shown to counteract these
effects, preventing viral replication, by reducing ER stress3,4. In
addition, TYME-19 is believed to physically degrade viruses by
solubilizing the protective lipid layer and other structural
components, which prevent a virus from binding to and infecting a
cell.
“The demonstrated tolerability of this agent, the multiple
antiviral mechanisms of TYME-19, and the recent finding that
certain bile acids occur naturally as part of our response to viral
infection, make it an exceptional potential treatment against a
virus that spreads rapidly, like COVID-19,” said Dr. John Rothman,
Executive Vice President, Product Development at TYME. “Although
bile acids have traditionally been developed for hepatic disease,
they have recently been recognized as steroid hormones with broad
metabolic functions in the body including neuro- and
cardio-protective roles, as well as antiviral properties. TYME-19
is a synthetic bile acid with numerous therapeutic effects,
including broad spectrum antiviral activity that has yet to be
exploited. Its ability to inhibit viral replication leaves open the
question of whether it may not just be a potential therapy for
early stage disease but may also be a prophylactic therapy.”
Beyond TYME-19, TYME is utilizing its experience in cell
metabolism to identify a pipeline of proprietary oral compounds
that are designed to have improved antiviral efficacy for use
against COVID-19 and future viral outbreaks.
“We hope that TYME-19 can soon be an important treatment
alternative for doctors in the fight against COVID-19,” said Steve
Hoffman, TYME’s Chairman and CEO. “We chose TYME-19 because of its
similarity to our metabolic cancer agent TYME-18, the breadth of
research, its ease of manufacturing and oral administrability.
Moreover, we believe metabolic agents have been largely overlooked
for their potential as innovative therapies that could save lives,
change the course of care and ultimately reduce the burden on
healthcare systems. At the same time, we remain committed to our
cancer metabolism-based development programs and we will continue
to follow the science to where we can improve the lives of patients
in need.”
About Tyme Technologies
Tyme Technologies, Inc., is an emerging biotechnology company
developing cancer therapeutics that are intended to be broadly
effective across tumor types and have low toxicity profiles. Unlike
targeted therapies that attempt to regulate specific mutations
within cancer, the Company’s cancer metabolism-based approach is
designed to take advantage of a cancer cell’s innate metabolic
weaknesses to compromise its defenses, leading to cell death
through oxidative stress and exposure to the body’s natural immune
system. For more information, visit www.tymeinc.com. Follow us on
social media: @tyme_Inc, LinkedIn, Instagram, Facebook and
YouTube.
Forward-Looking Statements/Disclosure Notice
In addition to historical information, this press release
contains forward-looking statements under the Private Securities
Litigation Reform Act that involve substantial risks and
uncertainties. Such forward-looking statements within this press
release include, without limitation, statements regarding our drug
candidates, including SM-88 and TYME-18, and their clinical
potential and non-toxic safety profiles, our drug development plans
and strategies, ongoing and planned preclinical and clinical
trials, including the proposed TYME-19 proof-of-concept study,
preliminary data results and the therapeutic design and mechanisms
of our drug candidates; and readers can identify forward-looking
statements by sentences or passages involving the use of terms such
as “believes,” “expects,” “hopes,” “may,” “will,” “plan,”
“intends,” “estimates,” “could,” “should,” “would,” “continue,”
“seeks,” or “anticipates,” and similar words including their use in
the negative or by discussions of future matters such as effect of
the novel coronavirus (COVID-19) pandemic and the associated
economic downturn and impacts on the Company's ongoing clinical
trials and ability to analyze data from those trials, the cost of
development and potential commercialization of our lead drug
candidate and of other new products, expected releases of interim
or final data from our clinical trials, possible collaborations,
the timing, scope and objectives of our ongoing and planned
clinical trials and other statements that are not historical. The
forward-looking statements contained in this press release are
based on management’s current expectations, which are subject to
uncertainty, risks and changes in circumstances that are difficult
to predict and many of which are outside of TYME’s control. These
statements involve known and unknown risks, uncertainties and other
factors which may cause the Company’s actual results, performance
or achievements to be materially different from any historical
results and future results, performances or achievements expressed
or implied by the forward-looking statements. These risks and
uncertainties include, but are not limited to, the severity,
duration, and economic impact of the COVID-19 pandemic; that the
information is of a preliminary nature and may be subject to
change; uncertainties inherent in the cost and outcomes of research
and development, including the cost and availability of
acceptable-quality clinical supply and the ability to achieve
adequate clinical study design and start and completion dates; the
possibility of unfavorable study results, including unfavorable new
clinical data and additional analyses of existing data; risks
associated with early, initial data, including the risk that the
final data from any clinical trial may differ from prior or
preliminary study data; final results of additional clinical trials
that may be different from the preliminary data analysis and may
not support further clinical development; that past reported data
are not necessarily predictive of future patient or clinical data
outcomes; whether and when any applications or other submissions
for SM-88 may be filed with regulatory authorities; whether and
when regulatory authorities may approve any applications or
submissions; decisions by regulatory authorities regarding labeling
and other matters that could affect commercial availability of
SM-88; the ability of TYME and its collaborators to develop and
realize collaborative synergies; competitive developments; and the
factors described in the section captioned “Risk Factors” of TYME’s
Annual Report on Form 10-K filed with the U.S. Securities and
Exchange Commission on May 22, 2020, as well as subsequent reports
we file from time to time with the U.S. Securities and Exchange
Commission available at www.sec.gov.
The information contained in this press release is as of its
release date and TYME assumes no obligation to update
forward-looking statements contained in this release as a result of
future events or developments.
1Marin, J.J., et al., Bile Acids in Physiology, Pathology and
Pharmacology. Curr Drug Metab, 2015.17(1): p. 4-29. 2Claudel, T.,
B. Staels, and F. Kuipers, The Farnesoid X receptor: a molecular
link between bile acid and lipid and glucose metabolism.
Arterioscler Thromb Vasc Biol, 2005. 25(10): p. 2020-30. 3Yang, X,
et al., Activation of autophagy by unfolded proteins during
endoplasmic reticulum stress. The Plant Journal (2016) 85, 83–95
4Umut O¨ zcan, U., et al., Chemical Chaperones Reduce ER Stress and
Restore Glucose Homeostasis in a Mouse Model of Type 2 Diabetes.
Sciencemag.org/cgi/content/full/313/5790/1137/DC1
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