Skye Bioscience gets Australian HREC nod to begin first-in-human phase 1 study of SBI-100 ophthalmic emulsion
Skye Bioscience, Inc., a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma, has received regulatory approval to begin its first-in-human phase 1 clinical study of SBI-100 ophthalmic emulsion (SBI-100 OE) from the Australian Human Research Ethics Committee (HREC). SBI-100 OE is a patented drug representing a new class of therapeutics to potentially treat glaucoma.
The primary endpoints for this randomized, double-masked, placebo-controlled phase 1 study of SBI-100 OE are an assessment of safety and tolerability of the drug in healthy volunteers. The secondary endpoint is an assessment of pharmacokinetics. The study will also measure changes to intraocular pressure. A total of 48 subjects will be administered SBI-100 OE or placebo in single ascending dose (SAD) and multiple ascending dose (MAD) arms. Preliminary top-line data is expected in Q4 and final data in Q1 of 2023.
In the study, each arm will consist of three cohorts of eight subjects, six receiving SBI-100 OE and two receiving placebo. In the SAD arm, each subject will be administered a single 35uL drop to one study eye of placebo or SBI-100 OE at concentrations of 0.5%, 1.0% and 2.0% of active drug in cohorts one, two, and three, respectively. In the MAD arm, each subject will receive two drops per day over five days using the respective dose levels of the SAD arm. A Safety Review Committee will monitor the study and review safety data before approving escalation to the next cohort.
“After submitting our clinical trial protocol to HREC in March, we are pleased to receive their approval and look forward to assessing SBI-100 Ophthalmic Emulsion for the first time in humans,” said Tu Diep, Chief Development Officer of Skye. “Decades of research have established the role of cannabinoid receptor type 1 (CB1R) in lowering IOP, however, there has been no CB1R agonist therapeutic agent approved by a regulatory agency to treat glaucoma. No other company has methodically created a patented molecule and proprietary formulation – representing a new class of therapeutic drug – to improve the inherent positive attributes of natural cannabinoids while limiting potentially negative systemic effects, and with the goal of enhancing the treatment of glaucoma beyond today’s approved drugs.
“Achieving these goals is Skye’s focus. We have not only created a drug with this ambition but we have also navigated the complexities of synthetic manufacturing and conducted extensive preclinical assessments, and now we are embracing the rigors of the clinical and regulatory processes to validate our drug.”
The phase 1 study will be conducted in the clinical trial facility of CMAX Clinical Research in Adelaide, Australia (CMAX). Conducting the phase 1 clinical study in Australia qualifies Skye to receive a tax credit of up to 43.5%.
“Glaucoma is still an inadequately treated disease that has lacked pharmacological innovation for decades. There is a need for new classes of therapeutics with differentiated mechanisms of action and we have strong conviction in the potential of our novel drug based on relevant independent research and our preclinical data,” said Punit Dhillon, CEO and Chair of Skye. “This study will be the first time a novel cannabinoid prodrug will be topically delivered into human’s eyes using a nanoemulsion formulation, and marks an important step in the development of SBI-100 Ophthalmic Emulsion to demonstrate the safety of this approach. Importantly, this study may also provide initial insights into this drug’s effect on IOP.
“In parallel, we aim to submit an investigational new drug (IND) application, which is not dependent upon Phase 1 data, with the FDA by year-end for our planned US-based phase 2 in 2023 to assess efficacy and safety in patients with glaucoma.”
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. Alternatively, extracted natural cannabinoids delivered topically as an eye drop do not penetrate ocular tissue well enough to effectively lower IOP due to the lipophilic, or oily, properties of natural cannabinoids and the aqueous, or watery, surface of the eye.
To address these challenges, Skye developed 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 also demonstrated advantages compared to today’s standard of care and, if clinically validated in subsequent efficacy studies, may provide a suitable therapeutic window to be a new class of medicine for glaucoma.
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.
