Skye Bioscience inc (OTCQB:SKYE) issued a letter to its shareholders written by CEO Punit Dhillon, highlighting the achievements of 2021 and providing the business outlook for 2022.
“2021 represented an important year of fundamental progress for Skye,” Dhillon said. “We further strengthened our team and work towards completing the preclinical development necessary to advance SBI-100 into the clinic. Our preclinical research to date gives us confidence that SBI-100 can be a promising drug candidate to treat glaucoma, the world’s leading cause of irreversible blindness.”
For 2022, Dhillon told investors that the company is preparing to make significant headway with the clinical development of SBI-100, the expansion of its R&D program, and the placement of resources and capabilities to support the escalating contributions toward disruptive innovation in the development of pharmaceutical cannabinoids.
READ: Skye Bioscience has a pipeline of synthetic cannabinoid drugs that can disrupt the way we treat diseases
The CEO said that in 2022, the company is looking to complete a Phase I study to establish the safety and tolerability of SBI-100 in humans. It will also initiate a robust placebo and active-controlled Phase II study for SBI-100 in glaucoma.
“We are fast approaching the initiation of our first-in-human Phase I study in the first half of 2022, with topline data expected in the third quarter of 2022 and the full data readout in the fourth quarter,” Dhillon said. “The objective is to check an important box for regulatory authorities by demonstrating that our drug has minimal to no side effects in the eye and no unwanted systemic side effects from THC.”
The San Diego, California-based company is also going to establish a drug development platform to uncover novel molecules and mechanisms of action capable of modulating the endocannabinoid system to improve outcomes for a broad set of ophthalmic diseases, Dhillion shared.
Skye Bioscience’s achievements of 2021 included the completion of several important preclinical studies to demonstrate the safety and efficacy of SBI-100. “In vitro safety studies included an epi-ocular irritation study that demonstrated little to no irritation induced by its eye drop formulation, plus genotoxicity studies that demonstrated SBI-100 caused no chromosomal damage or genetic mutations,” Dhillon wrote.
The company also welcomed six new members to its team in 2021, adding vital roles and pertinent pharmaceutical development experience, Dhillon said.
Skye Bioscience is a biopharmaceutical company unlocking the pharmaceutical potential of cannabinoids through the development of its proprietary, cannabinoid-derived molecules to treat diseases with significant unmet needs.
Contact Ritika at ritika@proactiveinvestors.com