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Skye Bioscience Doses First Cohort of Participants in Phase 1 Clinical Trial of SBI-100 Ophthalmic Emulsion
San Diego, California--(Newsfile Corp. - December 16, 2022) - Skye Bioscience, Inc. (OTCQB: SKYE) ("Skye" or the "Company"), a pharmaceutical company
About this update from Skye Bioscience, Inc.
[{"type":"text","content":"San Diego, California--(Newsfile Corp. - December 16, 2022) - Skye Bioscience, Inc. (OTCQB: SKYE) (\"Skye\" or the \"Company\"), a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma and ocular hypertension, has completed dosing of SBI-100 Ophthalmic Emulsion (\"OE\") in the first cohort of healthy participants in the single ascending dose (\"SAD\") part of its Phase 1 study being conducted by CMAX Clinical Research in Adelaide, Australia.\nThe objective for this randomized, double-masked, placebo-controlled, single and multiple ascending dose study is to evaluate the safety, tolerability and pharmacokinetics of SBI-100 OE. Changes in intraocular pressure will also be evaluated. In this two-part study, a total of approximately 48 subjects are divided into three single ascending dose and three multiple ascending dose cohorts. In each cohort of eight participants, six will be administered SBI-100 OE and two placebo.\nIn the first SAD cohort, participants were administered a single topical dose of SBI-100 OE at a concentration of 0.5%. Participants are subsequently monitored for safety and tolerability over three days following dose administration. In the second and third cohorts of the SAD arm, participants will receive a single dose of SBI-100 OE at 1.0% and 2.0%, respectively. Recruitment of the second cohort will begin in January, with dosing planned for February.\n\"This first-in-human Phase 1 trial is a significant milestone for Skye and SBI-100 Ophthalmic Emulsion. We are pleased to complete this step of administering drug in our first study participants,\" said Punit Dhillon, CEO and Chair of Skye. \"We believe there is substantial evidence that targeting the CB1 receptor in the eye can reduce intraocular pressure and potentially represents a new drug class to help treat patients with glaucoma. We look forward to seeing the safety, tolerability and other characteristics of this molecule in this study.\"\nSkye announced that it had submitted an Investigational New Drug application for SBI-100 OE to the U.S. Food and Drug Administration on November 15, 2022. Once opened, the IND will allow the Company to conduct clinical trials in the United States. The Company intends to initiate a Phase 2 study in participants with primary open angle glaucoma and ocular hypertension in the Uni...