A new agreement between Emerald Health Therapeutics and Skye Bioscience will enable Phase II studies exploring the use of Skye’s proprietary synthetic cannabinoid-derivative therapeutic initially targeting glaucoma.
Glaucoma is the globe’s leading cause of irreversible blindness – affecting nearly 80 million people across the globe – and has no cure.
Skye Bioscience‘s lead programme, SBI-100 Ophthalmic Emulsion, is focused on treating glaucoma. SBI-100 OE is designed to improve the ocular solubility and permeability of a cannabinoid receptor-type 1 agonist.Â
So far, preclinical studies have demonstrated that topical application of the nanoemulsion results in enhanced therapeutic efficacy and duration of response, allowing for a potentially once-a-day application to the eye. The results showed superior lowering of intraocular pressure, a key risk factor in disease progression.
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Under the new agreement, which would see Skye acquire all of the issued and outstanding shares of Emerald in a share-for-share-transaction, Skye expects to have funding for a Phase II study which is expected to begin in the fourth quarter of 2022, following a Phase I study beginning in the second quarter of 2022.
Chair of the Skye’s special committee and president, CEO and board member of Invectys, Inc., Praveen Tyle, Ph.D., commented: “Skye’s proposed acquisition of Emerald stands to strengthen its balance sheet and ability to advance its well-positioned technology and development platform that has generated promising preclinical data in the past year and a half.Â
“Despite the constraints of Covid on all facets of the life science industry, Skye has completed the preclinical preparation necessary to launch its first-in-human study of its lead drug, SBI-100 OE, in the second quarter of 2022.Â
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“We expect regulatory approval to start our Phase I study and begin enrolling patients shortly. The transaction with Emerald is expected to provide funding into 2023 and, importantly, for our planned Phase II study starting in the fourth quarter of 2022.
“The shortcomings of today’s glaucoma drugs are significant for patients. Today we are focused on clinically validating what could potentially be an advantageous new class of therapeutic drug for glaucoma.Â
“With this in mind, we are actively designing a Phase II efficacy study to deliver potentially meaningful data, yet optimised to minimise time and cost. We believe we can see preliminary data from this study in 2023, and the nature of this data could be transformational from a validation and value creation perspective.Â
“Securing the capital to achieve these goals is vital. We believe that acquiring Emerald and its cash and non-cash assets would provide a more favourable capital cost for our shareholders compared to other alternatives in light of current investment market conditions.Â
“In addition, Emerald possesses a research and development facility in the greater Vancouver area licensed to undertake cannabinoid-related research under applicable Canadian law, which could be beneficial to Skye as we continue to progress our R&D efforts.”
Chair of the board’s Special Committee of Emerald Health Therapeutics, Bobby Rai, commented: “We are excited to present this opportunity with Skye to our shareholders. Since announcing the strategic pivot of Emerald last November, we have been working to wind down our past operations, monetise our non-cash assets, and apply our capital to a new investment opportunity. We have searched for a company with differentiated positioning and a pedigree of expertise and experience. We believe we have found it in Skye Bioscience.
“Emerald has always recognised the therapeutic potential of cannabinoids based on our experience with the body’s endocannabinoid system and its modulating and balancing activities in the body. We also recognise that the goal to clinically and commercially capitalise on the potential therapeutic benefits of cannabinoid-derived drugs may benefit from advanced technology and drug products with mechanisms of action or formulations enhanced to realise effects superior to not only natural cannabinoids but to existing approved classes of drugs and those under development.Â
“The beauty of this situation is that the underlying cannabinoid that Skye is working with has previously been shown through prior third-party research to have promising potential. And Skye’s recent preclinical work has shown improved delivery of the underlying cannabinoid to the back of the eye and notable effects in reducing intraocular pressure, which is a key risk factor of glaucoma.
“Skye Bioscience has proprietary technology, R&D initiatives to expand its therapeutic capabilities, a strong focus on IP, along with a management team, board, and advisory board with many decades of experience in pharmaceutical drug development and clinical practice, notably in ophthalmology and in fundamental cannabinoid research. This company is uniquely positioned to capitalise on the substantially untapped opportunities represented by the intersection of cannabinoids with modern science and traditional drug development.
“We believe this is an excellent opportunity for Emerald shareholders to potentially benefit from a new class of cannabinoid-derivative drug candidates.”
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