Skye Bioscience (OTCQB: SKYE) Heads Into 2023 As A Clinical-Stage Company After Dosing Its First Human Participants

This year has been quite busy for Skye Bioscience Inc. SKYE. Looking back, as the year draws to a close, the company has chalked up some key successes that could shape its future and perhaps even the biopharma industry as a whole.

Since 2011, the California-based biopharmaceutical company has been focused on developing proprietary, synthetic cannabinoid-derived molecules for treating diseases with significant unmet needs. Its new management team has since 2020 undertaken and completed all the preclinical steps necessary to get into the clinic.

Skye reports that its lead molecule, in preclinical studies, has demonstrated potential as a new class of therapy to lower intraocular pressure in patients with glaucoma or elevated intraocular pressure that is superior to currently available drugs.

Unlike other players in the industry, like Sight Sciences Inc. SGHT and  Glaukos Corp. GKOS, Skye Bioscience’s work is unlocking the potential of cannabinoids through developing its proprietary cannabinoid derivatives to treat diseases with significant unmet needs. 

The company’s lead program, SBI-100 Ophthalmic Emulsion (SBI-100 OE), is focused on developing a treatment for glaucoma, the world’s leading cause of irreversible blindness.

As is widely known, current drugs often have diminishing utility as patients develop tolerance to them. Due to this, the company believes there is a need for a drug that can also lower intraocular pressure but is based on a different mechanism of action, and SBI-100 could be the best alternative.

Compared to products on the market like Rocklatan® and Rhopressa® from Aerie Pharmaceuticals, which was recently acquired by Alcon AG ALC, Skye says its product is the first synthetic cannabinoid eye drop designed to be able to enter the eye.

A Look At Some Of The Key Milestones

Acquisition of Emerald Health Therapeutics

On November 10, the company announced that it had concluded a merger transaction with Emerald Health Therapeutics. Both companies’ shareholders voted in favor of the merger, and the Supreme Court of British Columbia approved the transaction.

Sky says the transaction has brought additional capital and monetizable assets to the company, as well as a research and development (R&D) facility in Greater Vancouver, Canada.

The company believes that having the facility in Canada could provide more flexibility in dealing with controlled substances.

First Cohort Of Participants In Phase 1 Clinical Trial Dosed

On December 16, Skye Bioscience reported that it had completed the dosing of the first cohort of healthy volunteers in the single ascending dose (SAD) part of the Phase 1 study being conducted by CMAX  Clinical Research in Adelaide, Australia.

According to the company, the objective of the 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 (SAD) and three multiple ascending dose (MAD) cohorts. In each cohort of eight participants, six will be administered SBI-100 OE and two placeboes.

The company explained that in 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.

IND Application And The Future

After the first-in-human Phase 1 trial for SBI-100 OE in Australia, the company revealed that it is already working on a  Phase 2 study in patients with primary open-angle glaucoma and ocular hypertension in the U.S. in the first half of 2023.

Skye had already submitted in November an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for SBI-100 OE. On December 20th it announced that it had the okay from the FDA to move forward with its IND and its plans for US clinical studies.

Looking into the future, the company reports that it is aiming for data from the Phase 2 trial in Q1 2024, which could be a rapid timeline for a company that was still preclinical in November 2022.

"The data, if it shows notable lowering of intraocular pressure, could indicate the potential of SBI-100 OE to be an important new class of drug to help patients facing the effects of glaucoma," the company said.

During 2022, the company increased its R&D activities and it recently hired its first Chief Scientific Officer, Chris Twitty, Ph.D., all with the goal of expanding its clinical pipeline of drug candidates.

“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,” said Punit Dhillon, CEO and Chair of Skye. “With the key milestones of recently starting our first-in-human Phase 1 trial and the FDA’s okay to start clinical studies in the United States paving the way for our planned Phase 2, we are glad to be advancing the assessment of SBI-100 OE’s potential to treat glaucoma.”  

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