Pii Congratulates Skye Bioscience for First-in-Human Phase 1 Trial to Potentially Treat Glaucoma

Pii Congratulates Skye Bioscience for First-in-Human Phase 1 Trial of Proprietary Cannabinoid Derivative and Nanoemulsion Formulation Designed to Potentially Treat Glaucoma.

PRESS RELEASE Hunt Valley, MD (January 24, 2023)

Pharmaceutics International, Inc. (Pii), a contract development and manufacturing organization (CDMO), proudly celebrates a first-in-human Phase I clinical study for Skye Bioscience, Inc.’s (SKYE: OTCQB) proprietary, synthetic cannabinoid derivative, SBI-100 Ophthalmic Emulsion (OE), which has been designed to advance a new mechanism of action with potential as a treatment for glaucoma.

Increased intraocular pressure (IOP) is a key risk factor in the progression of glaucoma, an eye disease that leads to blindness. Independent studies have demonstrated that activating the cannabinoid receptor-type 1 (CB1R) in ocular tissue mediates IOP-lowering. Skye’s synthetic cannabinoid derivative, a molecule licensed from the University of Mississippi, possesses a novel molecular structure and formulation that was rationally designed to enable effective topical delivery and better penetration of ocular tissue of a CB1R agonist. In preclinical studies involving three different species, a nanoemulsion formulation of Skye’s drug applied topically to the eye was effective in lowering IOP and compared favorably to today’s standard of care for lowering IOP.

Skye initiated its first-in-human Phase 1 clinical study of SBI-100 OE in Australia in November and dosed the first cohort of healthy participants in December. The 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. The study will enroll approximately 48 participants. Skye expects to complete enrollment of the study and report data in 2023. Skye is also working to initiate a U.S.-based Phase 2 study in participants with primary open-angle glaucoma and ocular hypertension in the first half of 2023.

“We are pleased to have reached an important milestone of study participants being dosed with our drug candidate,” said Punit Dhillon, CEO, and Chair of Skye Bioscience. “This wouldn’t have been possible without the joint effort of the Skye and Pii teams working diligently to get the drug manufactured and released. Not only is this a developmental and operational achievement, but it is also an important step for this new class of molecule. It should be underscored that we built a proprietary process together, along with the help of Delphi Scientific, LLC and the team at Dyhydromatics. As they say, ‘it takes a village.’”

Pii manufactured both placebo and active batches of SBI-100 OE for clinical trial materials (CTMs) in the Phase 1 study. Devan Patel, Pii’s Vice President of Client Services said: “A holistic approach to process development, integration, and scale-up with the Skye team supported successful, scalable production of nanoemulsion formulations from lab techniques to production techniques, including the establishment of a proprietary manufacturing process.”

“Developing a scalable nanotechnology-based drug with Skye Bioscience was a unique first-of-its-kind undertaking for Pii, said John Fowler, President and CEO of Pii. “We learned a lot from the expertise that Skye brought in to supplement the production and manufacturing team at Pii. Creating this proprietary formulation of its synthetic product in the form of an eye drop gives Skye’s SBI-100 Ophthalmic Emulsion an exciting opportunity as a potential new class of treatment for glaucoma. We look forward to working with Skye on additional projects in their drug development pipeline.”

About Skye Bioscience
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. The Company's lead program, SBI-100 Ophthalmic Emulsion, is focused on developing a treatment for glaucoma, the world's leading cause of irreversible blindness. For more information, visit: www.skyebioscience.com.

About Pii
Pharmaceutics International, Inc. (Pii) is a US-based contract development and manufacturing organization (CDMO) with a passion for solving problems. Pii’s Hunt Valley, Maryland, campus includes 70 manufacturing suites with four integrated aseptic filling lines. We offer contract analytical development and support formulation and manufacturing of oral solid dosage forms. Our professionals have extensive experience with small and large molecule compounds, developing and manufacturing complex parenteral drugs, extended-release formulations, non-aqueous injectable drug products, and lyophilization. Pii is proudly the first to market with THC soft gels, highlighting our experience with FDA-approved cannabis products.
Learn more at www.pharm-int.com.

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