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Skye Bioscience Receives FDA Authorization of
Investigational New Drug Application for SBI-100 OE
Phase 2 clinical trial planned to start in H1
2023
San
Diego, California, December 20, 2022 -- InvestorsHub NewsWire --
Skye Bioscience, Inc. (OTCQB:
SKYE) ("Skye" or the "Company"), a pharmaceutical company
developing a proprietary, synthetic cannabinoid derivative to treat
glaucoma, today announced that the U.S. Food and Drug
Administration ("FDA") has given the okay to proceed for the
Investigational New Drug ("IND") application for SBI-100 Ophthalmic
Emulsion ("OE"). This enables the Company to initiate clinical
trials in the United States, including its planned Phase 2 study
for primary open angle glaucoma or ocular hypertension in the first
half of 2023.
SBI-100
OE is a synthetic cannabinoid derivative that targets the CB1
receptor, which plays a key role in managing IOP. It is a novel
synthetically-derived molecule formulated as an eye-drop using a
propriety nanoemulsion to improve delivery into the eye. SBI-100 OE
displayed favorable results in animal studies as a monotherapy and
in combination with standard of care ("SOC") glaucoma drugs
compared to SOC alone and other combinations. A first-in-human
Phase 1 clinical trial in healthy participants recently started in
Australia.
"We are
pleased to receive the okay from the FDA on our IND submission,
which we accomplished by year end, as planned," said Tu Diep, Chief
Development Officer of Skye. "We have dosed the first cohort of
participants in our Phase 1 trial in Australia. With our IND
active, our team is advancing the manufacturing and clinical
planning steps to begin our planned Phase 2 in the US. We expect to
initiate Phase 2 in the first half of 2023 and report data in Q1
2024."
Punit
Dhillon, CEO and Chair of Skye, said, "Multiple scientific studies
have shown that cannabinoids can reduce intraocular pressure. What
was missing to create an effective medicine was a method to safely
and effectively deliver a therapeutic dose into the eye. Based on
the design of this first-ever new drug class and the nonclinical
data we have achieved, we believe we have overcome the challenge of
the delivery method. We look forward to a productive 2023."
About SBI-100 Ophthalmic Emulsion
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
materially negatively affected. In some cases, forward-looking
statements can be identified by terminology including
"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.