Skye Bioscience Reports Positive Results for SBI-100 in GLP Toxicology Study

Skye Bioscience, Inc. recently announced it has completed a good laboratory practice (GLP) nonclinical toxicology study of its SBI-100 ophthalmic nanoemulsion in support of the company’s planned Phase 1 first-in-human clinical trial in Australia.

The purpose of this study was to evaluate the ocular toxicity and toxicokinetics of SBI-100 ophthalmic nanoemulsion when administered to rabbits either two or three times daily at multiple doses by topical ocular administration for fourteen consecutive days. The reversibility of potential test article-related effects was also assessed following a drug-free recovery period. No histological changes were observed in the eye and no adverse findings in remaining organs resulting from SBI-100 administration. Based on these results, a no-observed-adverse-effect level (NOAEL) was observed, allowing for the determination of a starting dose for the upcoming Phase 1 clinical trial.

These data will support Skye’s submission of a clinical trial application to the Human Research Ethics Committee (HREC) in Australia to initiate a Phase 1 first-in-human clinical trial of SBI-100. Subject to approval by the HREC and acceptance of the Clinical Trial Notification (CTN) by Australia’s Therapeutic Goods Administration (TGA), Skye expects to initiate this clinical study in the second quarter of 2022.

“We believe there is potential for SBI-100 to be a disruptive and potentially transformative treatment option for patients suffering from glaucoma. We have worked diligently to complete the preclinical steps required for our submission to the Australian Therapeutic Goods Administration, and these positive GLP toxicology results represent the final nonclinical dataset needed to complete our submission,” said Tu Diep, Chief Development Officer. “Upon receiving the required approvals from the Australian regulatory agencies, we plan to initiate our Phase 1 clinical trial of SBI-100 and dose our first patient in the second quarter of 2022.”

SBI-100, a proprietary prodrug of tetrahydrocannabinol (THC), is a topical ocular formulation under development for the treatment of glaucoma. Developed with rational drug design and biochemical engineering, SBI-100 is a proprietary synthetic molecule that enables local delivery of the drug into the eye and reduces the potential for systemic side effects. In nonclinical studies, SBI-100 demonstrated superior lowering of intraocular pressure, a significant risk factor related to irreversible vision loss, compared to the standard-of-care glaucoma treatment.

Skye Bioscience Inc. is a biopharmaceutical company unlocking the pharmaceutical potential of cannabinoids through the development of its proprietary, cannabinoid-derived molecules to treat diseases with significant unmet needs. 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. For more information, visit www.skyebioscience.com.