Modern cannabis research reportedly began with Israeli scientists Raphael Mechoulam and Yechiel Gaoni who, in 1964, isolated and identified tetrahydrocannabinol (THC).
Mechoulam later also elucidated the chemical structure of several other cannabis components including cannabidiol (CBD), which the scientists found to be an intriguing, non-intoxicating molecule.
They called these unique botanical compounds “cannabinoids,” likening the plant to “a pharmacological treasure trove.”
In the 1970s, Robert Hepler, MD, and Ira Frank, MD, explored the effects of cannabis on visual acuity in humans and discovered that cannabis had an unexpected effect of lowering intraocular pressure, a key risk factor in glaucoma. This led to a significant amount of research on the role of cannabinoids in the eye, which outside of the brain are the organs that contain the greatest number of cannabinoid receptors. However, at that time researchers were unable to find a way to effectively deliver a therapeutic dose of cannabis without avoiding its intoxicating effects.
Jump ahead to 2022, and you’ll find unique and advanced studies conducted around the world, and by companies like San Diego’s Skye Bioscience Inc. SKYE. The pharmaceutical company reports improving the effects of cannabinoid molecules by making molecular changes to the structure of a naturally occurring molecule to enhance its therapeutic benefit, through the endocannabinoid system, which is increasingly being shown to play a vital role in critical systems and functions in the body.
Skye Heads Down Under For Phase 1 Trials
Skye’s lead program is focused on developing a proprietary and synthetic cannabinoid derivative to treat glaucoma. The company 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 new class of therapeutics to potentially treat glaucoma and is a novel drug protected by composition of matter patents.
“After submitting our clinical trial protocol to HREC in March, we were pleased to receive their approval in June and look forward to assessing SBI-100 Ophthalmic Emulsion drug for the first time in humans,” Skye Chief Development Officer Tu Diep said. “Independent research has shown the utility of introducing a cannabinoid receptor type 1 agonist into the eye to reduce intraocular pressure (“IOP”) related to glaucoma. Yet few companies have methodically created a protected molecule and formulation — and a whole new class of therapeutic drug — that substantially improves the inherent attributes of a natural cannabinoid.”
Early Study Results Positive?
In preclinical studies, Skye’s lead drug candidate showed superior and longer-lasting lowering of intraocular pressure, a risk factor associated with glaucoma. The company is also looking for results in its randomized, double-masked, placebo-controlled Phase 1 study of SBI-100 OE, which will assess the drug's safety and tolerability in healthy volunteers. The secondary endpoint is to evaluate the pharmacokinetics, which is the activity of drugs in the body over time, including absorption, distribution, tissue localization and excretion.
In addition, the Skye study is set to measure changes in intraocular pressure using 48 healthy subjects who will be administered SBI-100 OE or a placebo in single ascending dose and multiple ascending dose arms, which is a clinical trial design used to characterize its safety and tolerability. Changes to IOP will also be assessed and potentially give early insights to the efficacy of SBI-100 OE. The company aims to report preliminary topline data by the first quarter of 2023, with final data becoming available in the second quarter of 2023.
“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,” Skye CEO Punit Dhillon said. “We are also preparing to submit an investigational new drug application with the U.S. Food and Drug Association (FDA) that will allow for a U.S.-based Phase 2 study designed to assess efficacy and safety in patients with glaucoma, with data expected in 2023.”
“No company has sorted out the complexities of synthetic manufacturing, conducted extensive preclinical assessments and entered into the scrutiny of the clinical and regulatory process to validate such a drug like we have,” Diep added. “We have embraced all these steps and will make our best effort to overcome the limitations of today’s glaucoma treatments.”
For more information on Skye Bioscience, visit www.skyebioscience.com.
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