Skye Bioscience inc (OTCQB:SKYE) announced that the peer-reviewed journal International Journal of Pharmaceutics has published preclinical data demonstrating stronger and longer-lasting reduction of intraocular pressure (IOP) when Skye's proprietary molecule, SBI-100, is formulated as a nanoemulsion containing the mucoadhesive agent Carbopol 940.
The pharmaceutical company, which is developing proprietary, synthetic cannabinoid derivatives to treat glaucoma and other diseases, said a first in-human study of the formulation is planned to start this quarter.
The results of the research were published in March this year in a paper titled ‘Impact of mucoadhesive agent inclusion on the intraocular pressure lowering profile of Delta9-tetrahydrocannabinol-valine-hemisuccinate loaded nanoemulsions in New Zealand white rabbits’, authored by C Sweeney et al. from the University of Mississippi (UM).
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Skye, in collaboration with UM, has previously published preclinical data demonstrating that SBI-100 formulated as a nanoemulsion (THC-VHS-NE) achieved greater reduction of IOP in non-pigmented rabbits than both latanoprost and timilol1, the current first and second line treatments for glaucoma.
The company said the current study was undertaken to determine if the inclusion of a mucoadhesive agent could prolong the intensity and duration of action of the THC-VHS-NE formulation through increased residence time or penetration, or both, to potentially achieve once- or twice- a day dosing.
In this study, sponsored by Skye, researchers at UM compared the reduction of IOP in normotensive (normal blood pressure) rabbits with a single treatment of THC-VHS-NEC (SBI-100 formulated as a nanoemulsion with Carbopol 940) compared to latanoprost, which is the commercial standard of care; compared to THC-NEC (native THC formulated as a nanoemulsion with Carbopol 940); and also compared to THC-VHS-NE (SBI-100 formulated as just a nanoemulsion).
When comparing each treatment group, THC-VHS-NEC, Skye's SBI-100 Opthalmic Emulsion, demonstrated the greatest intensity and duration of IOP-lowering, the company noted.
"Skye has been working aggressively to optimize a formulation of SBI-100 to advance toward a first in-human study, which is planned to start this quarter,” Punit Dhillon, CEO and chair of Skye said in a statement.
“We previously reported strong preclinical results that highlighted the superior IOP-lowering of our unique molecule formulated as just a nanoemulsion compared to other established commercial glaucoma drugs.
“This further evolution of our formulation, generating even more robust results, gives us strong conviction as we step into the clinic with SBI-100 Ophthalmic Emulsion," Dhillon added.
"Our aim with this program is to advance a new class of glaucoma treatment with a once or twice a day dosing regimen. Positive, prior third-party research relevant to our molecule and this preclinical work informed our selection of the best formulation of SBI-100 for this application.
“We appreciate that these results are peer-reviewed by a recognized scientific journal."
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 need.
The company's lead program, SBI-100, is focused on treating glaucoma, a disease with no cure and the world's leading cause of irreversible blindness.
Contact the author at jon.hopkins@proactiveinvestors.com