Skye Bioscience inc (OTCQB:SKYE) announced that 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 San Diego-based company said that 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.
Skye said that no histological changes were observed in the eye and no adverse findings in the remaining organs resulting from SBI-100 administration. Based on these results, a no-observed-adverse-effect level (NOAEL) was observed, furthering the starting dose for the upcoming Phase 1 clinical trial.
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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, the company said.
Skye expects to initiate this clinical study in the second quarter of 2022 after receiving approval from the HREC and acceptance of the Clinical Trial Notification (CTN) by Australia’s Therapeutic Goods Administration (TGA).
“We believe there is potential for SBI-100 to be a disruptive and potentially transformative treatment option for patients suffering from glaucoma,” said Tu Diep, chief development officer of Skye Bioscience. “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.”
He added: “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.”
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