Skye
Bioscience's THCVHS Demonstrates
Superior
Therapeutic
Benefit
Compared
to Glaucoma
Standard
of Care,
both as Combination
and
Single
Agent,
in
Preclinical
Study
-
THCVHS
combined with netarsudil
(Rhopressa®)
achieves
an
average
maximum
intraocular
pressure (IOP)
reduction
of
32.4%
and
maintains
an
average
IOP
reduction of 26.5%
at
9
hours,
significantly
better
than
any
single
drug
or combination
tested
-
THCVHS
demonstrates
superior
IOP-lowering and duration relative
to
glaucoma
standard of care, latanoprost
San Diego, Calif, May 17, 2021 -- InvestorsHub NewsWire
-- Skye
Bioscience, Inc. (OTCQB: SKYE) ("SKYE" or the "Company"), a
biopharmaceutical company developing proprietary, synthetic
cannabinoid-derived molecules to treat glaucoma and other diseases
with significant unmet need, announced that in a preclinical
study
assessing intraocular
pressure
(IOP)-lowering effects of its novel prodrug, THCVHS
combined
with netarsudil
demonstrated the
most significant IOP-lowering effects and duration of activity
compared to all other tested single and combined treatments. Data
from this study also highlighted THCVHS' superior IOP-lowering
capability and duration of
activity as a single agent
compared to the
current standard of care for the treatment of
glaucoma, latanoprost.
Elevated IOP is a key risk
factor in the progression of glaucoma and the result of fluid
build-up in the anterior compartment of the eye. Although
current therapies attempt to lower IOP by decreasing fluid
production or increasing fluid drainage, many patients respond
poorly to specific drugs, build tolerance, or do not experience
sufficient lowering of IOP to slow disease progression. More than
half of patients eventually require two or more drugs to
adequately
control their
IOP. This leaves a significant need and opportunity for
new
drugs
and
classes of
therapies, especially
ones that
increase
the
magnitude and duration of therapeutic
effects.
Previous studies
conducted
with
the
University of
Mississippi (UM) established that THCVHS
decreased IOP significantly and over a longer duration than the top
two commercially available treatments, latanoprost and
timolol. Clinical evidence suggests that combining different
classes of IOP-lowering drugs can provide additional benefit
for
some patients.
This new study was
designed,
in collaboration with UM, to determine the benefit of combining THCVHS with other
classes of IOP-lowering drugs, specifically
a
prostaglandin
analogue (latanoprost) and a rho kinase inhibitor
(netarsudil).
This study
demonstrated that THCVHS
combined
with netarsudil
achieved
superior
IOP-lowering and durability compared to
latanoprost.
Latanoprost's
average
maximum IOP-lowering effect was 21.3% and it returned to baseline after 9
hours; THCVHS combined with
netarsudil
achieved
an
average maximum IOP-lowering effect
of 32.4% and retained an average reduction in IPO
of 26.5% at 9 hours. The data also showed
superior
IOP-lowering compared to
netarsudil
combined
with
latanoprost.
This study also reaffirmed
THCVHS' superior ability to significantly
lower IOP over a longer duration compared to
latanoprost:
THCVHS achieved an average maximum reduction in IOP
of 27.5% and maintained
an
average reduction in IOP of 21.1% after 9
hours, at which point
latanoprost had returned to
baseline.
"Our
group has had significant experience formulating THCVHS for a
variety of therapeutic
indications and continues
to
discover new therapeutic applications
for
this
promising
molecule,"
said
Soumyajit
Majumdar, PhD, Professor, Department of Pharmaceutics and Drug
Delivery at
University of
Mississippi.
"This study again highlights THCVHS'
superiority as a single agent over latanoprost to lower intraocular
pressure, including its ability to maintain a significant
therapeutic
effect beyond nine hours.
Importantly, the data
also
suggests
the
potential to
further enhance the intraocular-pressure-lowering
capabilities of THCVHS by
combining it with specific
alternative
classes of
IOP-lowering drugs.
We
anticipate sharing
the complete
set of data as part of a manuscript to be submitted to a
peer-reviewed academic journal."
"This new study provides
positive new observations regarding THCVHS' potential to
provide
advantageous
therapeutic benefits for patients, both as a single agent
and combined with other
drugs, and we plan to
fully
investigate
these possibilities,"
said Punit Dhillon, Skye Bioscience, CEO. "These data
suggest
there is
strong potential for THCVHS to be a once-a-day treatment,
a desirable outcome for glaucoma treatments. With our recently announced
progression on manufacturing and
imminent
toxicology
studies,
we
continue
our
progress toward our first-in-human trial for
THCVHS that is intended to
start later this
year."
Study
design
This study was conducted in collaboration
with the University of Mississippi using three in vivo groups. Each group received a
single 50
µL dose of
THCVHS, latanoprost or netarsudil
once daily for
the first five days and then a combination of two different drugs
once daily for the next five days. In the combined drug
study, the second
drug was administered 15 minutes after administering the first
drug. IOP was measured over the course of 24
hours
on days 1, 3 and
5 using single drug treatment and
days 6, 8 and 10 using combination drug treatment.
The study was performed with the following treatment
regimens:
Single
Drug
Regimens
-
Group 1: THCVHS
1.0%
-
Group 2:
latanoprost 0.005%
-
Group 3:
netarsudil 0.02%
Combined Drug Regimens
-
Group 1: THCVHS
1.0% followed by
netarsudil
0.02%
-
Group 2:
latanoprost 0.005% followed by THCVHS
1.0%
-
Group 3:
netarsudil
0.02%
followed by
latanoprost 0.005%
About
THCVHS
THCVHS, a proprietary prodrug of
tetrahydrocannabinol (THC), is a topical ocular formulation under development
to treat glaucoma. Developed with rational drug design
and
biochemical
engineering, THCVHS is a proprietary
synthetic
molecule that enables local delivery of the drug
into the eye and reduces the potential for
systemic side
effects. In preclinical studies,
THCVHS demonstrated superior lowering of intraocular pressure,
a major risk factor related to
irreversible
vision
loss, compared to
the
standard-of-care glaucoma
treatment.
About the
University of Mississippi
The University of
Mississippi, the state's flagship institution, is among the elite
group of R-1: Doctoral Universities - Highest Research Activity in
the Carnegie Classification. The university has a long history of
producing leaders in public service, academics, research, and business. Its 15 academic
divisions include a major medical school, nationally recognized
schools of accountancy, law and pharmacy, and an Honors
College acclaimed for a blend of
academic rigor, experiential learning, and opportunities for
community action.
UM's research
interests include studies of the botanical, pharmacological and
chemical properties of the cannabis plant. Since 1968, the marijuana research lab at
University of Mississippi's School of Pharmacy has been the only
facility in the United States permitted by the federal government's National
Institute on Drug Abuse to cultivate cannabis for research
purposes.
About Skye
Bioscience
Skye Bioscience
Inc. is a biopharmaceutical company unlocking the pharmaceutical
potential of cannabinoids through the development of its
proprietary, cannabinoid-derived molecules to treat diseases with
significant unmet needs. The company's lead program, THCVHS, is
focused on treating glaucoma, a disease with no cure and the
world's leading cause of irreversible blindness.
For more
information, please visit:
www.skyebioscience.com.
CONTACT
Karam
Takhar
VP, Corporate
Development & Investor Relations
Email:
ir@skyebioscience.com
Phone: (858)
410-0266
FORWARD
LOOKING STATEMENTS
This press
release contains forward-looking statements, including statements
regarding our product development, business strategy, timing of
clinical trials and commercialization of cannabinoid-derived
therapeutics. Such statements and other statements in this press
release that are not descriptions of historical facts are
forward-looking statements that are based on management's current
expectations and assumptions and are subject to risks and
uncertainties. If such risks or uncertainties materialize or such
assumptions prove incorrect, our business, operating results,
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affected. In some cases, forward-looking statements can be
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"challenge," "predictable," "will," "would," "may" or the negative
of these terms or other comparable terminology. We operate in a
rapidly changing environment and new risks emerge from time to
time. As a result, it is not possible for our management to predict
all risks, nor can we assess the impact of all factors on our
business or the extent to which any factor, or combination of
factors, may cause actual results to
differ materially from those contained in any forward-looking
statements the Company may make. Risks and uncertainties that may
cause actual results to differ materially include, among others,
our capital resources, uncertainty regarding the results of future
testing and development efforts and other risks that are described
in the Risk Factors section of Skye's most recent annual or
quarterly report filed with the Securities and Exchange Commission.
Except as expressly required by law, Skye disclaims any intent or
obligation to update these forward-looking statements.
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