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Skye Bioscience (OTCMKTS: SKYE) to Initiate Phase 1 Clinical Trial of SBI-100 in the Second Quarter of 2022 after Positive Results from It’s In GLP Toxicology Study



There is a rising need to develop proprietary, cannabinoid-derived molecules to treat diseases with significant unmet needs. This is why Skye Bioscience (OTCMKTS: SKYE) has stepped out of its comfort to support this cause. The pharmaceutical company has released a nonclinical toxicology study of its SBI-100. The study evaluated the ocular toxicity and toxicokinetics of the proprietary prodrug of tetrahydrocannabinol (THC) on rabbits.

The drug was administered by topical ocular administration for fourteen consecutive days, either two or three times daily at multiple doses. And from the results, there were no histological changes observed in the eye, and neither were their adverse findings in other organs.

A Disruptive and Potentially Transformative Treatment Option for Glaucoma

According to Tu Diep, Chief Development Officer, the results will determine a dose for the upcoming Phase 1 clinical trial. They worked so hard to complete the preclinical steps required and are optimistic about approvals by the relevant authorities. The anticipation is that SBI-100 will support patients suffering from glaucoma, a rare eye disease with no cure and probably the world’s leading cause of irreversible blindness.

The drug demonstrated superior intraocular pressure lowering, and further steps into its development include interrogating its neuroprotective benefits.

Diep confirmed, “Upon receiving the required approvals from the Australian regulatory agencies, we plan to initiate our Phase 1 clinical trial of SBI-100 and dose our first patient in the second quarter of 2022.”

The Journey to Prepare SBI-100 Did not Happen Without Challenges

SBI-100 is Skye’s lead product, and as promising as it may sound, its preparation for its next stage of development had an array of challenges. Its setting was against the backdrop of a global pandemic. Applauding the shareholders, colleagues and collaborators, the CEO and Chair, Punit Dhillon, indicated that everyone had put their best foot forward to bring the novel cannabinoid-based compounds to life.

While all is said and done, the potential imdrug’s potential impactor that Skye is operating in a global pharmaceutical market. It is also an inspiration that it is one step ahead of innovation, and the urgency now is in focusing on executing meaningful goals until progress is achieved.

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