Skye Bioscience Doses First Cohort
of Participants in Phase 1 Clinical Trial of SBI-100 Ophthalmic
Emulsion
San Diego, California, December 16, 2022 -- InvestorsHub NewsWire
-- Skye Bioscience, Inc. (OTCQB: SKYE) ("Skye" or the "Company"), a
pharmaceutical company developing a proprietary, synthetic
cannabinoid derivative to treat glaucoma and ocular hypertension,
has completed dosing of SBI-100 Ophthalmic Emulsion ("OE") in the
first cohort of healthy participants in the single ascending dose
("SAD") part of its Phase 1 study being conducted by CMAX Clinical
Research in Adelaide, Australia.
The objective for this randomized, double-masked,
placebo-controlled, single and multiple ascending dose study is to
evaluate the safety, tolerability and pharmacokinetics of SBI-100
OE. Changes in intraocular pressure will also be evaluated. In this
two-part study, a total of approximately 48 subjects are divided
into three single ascending dose and three multiple ascending dose
cohorts. In each cohort of eight participants, six will be
administered SBI-100 OE and two placebo.
In the first SAD cohort, participants were administered a single
topical dose of SBI-100 OE at a concentration of 0.5%. Participants
are subsequently monitored for safety and tolerability over three
days following dose administration. In the second and third cohorts
of the SAD arm, participants will receive a single dose of SBI-100
OE at 1.0% and 2.0%, respectively. Recruitment of the second cohort
will begin in January, with dosing planned for February.
"This first-in-human Phase 1 trial is a significant milestone for
Skye and SBI-100 Ophthalmic Emulsion. We are pleased to complete
this step of administering drug in our first study participants,"
said Punit Dhillon, CEO and Chair of Skye. "We believe there is
substantial evidence that targeting the CB1 receptor in the eye can
reduce intraocular pressure and potentially represents a new drug
class to help treat patients with glaucoma. We look forward to
seeing the safety, tolerability and other characteristics of this
molecule in this study."
Skye announced that it had submitted an Investigational New Drug
application for SBI-100 OE to the U.S. Food and Drug Administration
on November 15,
2022. Once opened, the IND will allow the Company to conduct
clinical trials in the United States. The Company intends to
initiate a Phase 2 study in participants with primary open angle
glaucoma and ocular hypertension in the United States in the first
half of 2023.
About Glaucoma and SBI-100
Ophthalmic Emulsion
About 70 million people globally suffer from the debilitating
effects of glaucoma, according to the Glaucoma Research Foundation
and even more suffer from ocular hypertension, as represented by
the 3% of the US population reported by the British Journal of
Ophthalmology. There is a need for a new class of drugs that relies
on different mechanisms to affect disease progression.
Increased intraocular pressure (IOP) is a key risk factor in the
progression of glaucoma. The first observations that consuming
cannabis lowered IOP in humans took place in the early 1970s, which
led to a significant amount of research on the effects of
cannabinoids in the eye. Independent studies demonstrated that
activation of the cannabinoid receptor-type 1 (CB1R) in ocular
tissue mediates IOP-lowering. However, no cannabinoid-related drug
has been approved for clinical use in the eye due primarily to the
shortcomings of current delivery methods of CB1R agonists to the
eye in a therapeutically beneficial dose. When cannabinoids are
administered systemically, they can lower IOP but also result in
undesirable psychotropic effects. In high doses they can also cause
detrimental cardiovascular effects. Alternatively, extracted
natural cannabinoids delivered topically as an eye drop do not
penetrate ocular tissue well enough to effectively lower IOP,
likely due to the lipophilic, or oily, properties of natural
cannabinoids and the aqueous, or watery, surface of the
eye.
To address these challenges, Skye is developing SBI-100 OE, a
proprietary, synthetic cannabinoid derivative possessing a novel
molecular structure and formulation that was rationally designed to
enable better penetration of ocular tissue and effective topical
delivery of a CB1R agonist. In preclinical studies involving three
different species, a nanoemulsion formulation of the drug applied
topically to the eye resulted in enhanced therapeutic efficacy and
duration of response in lowering IOP. Importantly, these studies
demonstrated advantages compared to today's standard of care that,
if clinically validated in subsequent efficacy studies, may offer a
suitable therapeutic window to be a new class of medicine for
glaucoma.
About Skye Bioscience
Skye Bioscience is a pharmaceutical company unlocking the potential
of cannabinoids through the development of its proprietary
cannabinoid derivatives to treat diseases with significant unmet
needs. The Company's lead program, SBI-100 OE, is focused on
developing a treatment for glaucoma, the world's leading cause of
irreversible blindness. For more information, please visit:
www.skyebioscience.com.
CONTACT
Investor Relations
Email: ir@skyebioscience.com
Phone: (858) 410-0266
FORWARD LOOKING
STATEMENTS
This letter contains forward-looking statements, including
statements regarding our product development, business strategy,
the 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, financial condition, and stock price could be
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"anticipated," "plans," "goal," "focus," "aims," "intends,"
"believes," "can," "could," "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.