Skye Bioscience Inc (OTCQB:SKYE) has announced that the shareholders of Emerald Health Therapeutics Inc (CSE:EMH, OTCQX:EMHTF) have approved the proposed plan of arrangement which will result in the integration of the two companies, and also revealed regulatory approval to begin its first-in-human Phase 1 clinical study.
The pharma company said Emerald will now seek a final order from the Supreme Court of British Columbia to approve the arrangement.
"We are very pleased to see strong voting participation by Emerald Health Therapeutics shareholders at this meeting and their clear support of the proposal to merge with Skye Bioscience," Skye CEO and chair Punit Dhillon said in a statement.
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"We are preparing for Skye's shareholder meeting to vote on the plan of arrangement, and we continue to take the required steps to start our planned Phase 1 study in the fourth quarter," Dhillon added.
The Skye shareholders’ meeting is planned for October or November 2022, the company said, noting that the transaction is expected to close shortly thereafter, subject to Skye obtaining listing approval from the Canadian Securities Exchange and satisfaction of other customary conditions.
Phase 1 clinical study update
Skye also revealed that it has received regulatory approval to begin its first-in-human Phase 1 clinical study of SBI-100 Ophthalmic Emulsion, a patented drug representing a new class of therapeutics to potentially treat glaucoma, from the Australian Human Research Ethics Committee (HREC).
It said the contract manufacturer selected to manufacture Skye's placebo and SBI-100 drug products for the clinical study will begin production in early September 2022.
The company expects to complete enrollment for the study in early 2023 and to release interim data from that study in Q2 2023.
Skye said it expects to submit an Investigational New Drug application with the US FDA before the end of 2022 to obtain clearance to initiate a United States Phase II study in the first half of 2023. The study will assess the efficacy of SBI-100 in treating patients with primary open-angle glaucoma and ocular hypertension. The company expects to report data from this study by year-end 2023.
Glaucoma affects over 70 million people in the world and its prevalence is increasing, Skye added, noting that treatment for the disease is not fulfilled by current drugs and a novel class of drug such as SBI-100 could potentially benefit patients inflicted with the disease.
Skye also noted that Emerald has substantially completed the wind-down of its cannabis operations and is working to exit its remaining leases while searching for a purchaser for its Quebec production facility.
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 needs.
Contact the author at jon.hopkins@proactiveinvestors.com