SBI-100 is a pro-drug of Tetrahydrocannabinol (THC), which is being evaluated as a topical agent in ophthalmic suspension form.
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The
agent could be useful in the treatment of glaucoma and ocular hypertension.
The
agent has undergone a Phase 1 study with 2 cohorts each of 8 patients.
Skye
Bioscience, Inc., the parent company, has received positive recommendation following a pre-specified
data review by the safety review committee (SRC). The SRC has recommended that
the trial continue without modification. The company shall be recruiting the
third cohort soon.
In
nonclinical studies, Skye’s SBI-100 Ophthalmic Emulsion demonstrated a greater
and longer-lasting reduction of IOP compared to leading commercialized drugs in
the glaucoma market. These studies also demonstrated:
- SBI-100 Ophthalmic
Emulsion is better at penetrating various compartments of the eye than
natural THC
- THC in an ex vivo
model demonstrated a reduction of biomarkers related to fibrosis and
inflammation in conjunction with lowering of IOP, supporting a multimodal
mechanism of action
Previous preclinical
studies have shown the potential for THC to also provide neuroprotective
benefit, which may be especially important to patients with glaucoma who are
experiencing disease progression with normal IOP levels.
One of the major drawbacks of
previous studies concerning the use of THC for glaucoma was that they relied on
inhalation or ingestion of THC. These systemic routes of drug administration
cause negative side effects like psychotropic changes and potentially
decreasing blood pressure, which resulted in the American Academy of Ophthalmology
determining that the adverse effects of systemic cannabis
administration/consumption outweighed its therapeutic benefit.
Skye has chemically modified THC to
create a unique synthetic molecule with the intent to safely realize the known
positive effects of THC. The molecule enables enhanced local delivery in the
eye, reduced systemic side effects, and the potential for neuroprotection for
the treatment of ocular diseases.
HIGHLIGHTS:
SBI-100 OE is a cannabinoid receptor
type 1 (CB1R) agonist delivered topically into the eye. It is a synthetic
cannabinoid derivative to treat glaucoma and ocular hypertension. SBI-100 OE
possesses 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.”
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