Skye Bioscience inc (OTCQB:SKYE) said completion of the production of its Phase 1 drug has been delayed to the beginning of September 2022 due to a now resolved cyber-attack and planned maintenance shutdown at its contract manufacturer (CMO).
Skye said it now expects to initiate enrollment of its Phase 1 clinical study in Q4 2022, report preliminary topline data in early Q1 2023, and report final data in Q2 2023. Skye's SBI-100 Ophthalmic Emulsion (SBI-100 OE) had most recently been scheduled for production and fill in the first week of July 2022.
"The unpredictable events that have detrimentally affected our production schedule have been frustrating, but we are confident in the renewed commitment of our contract manufacturer to produce our clinical trial material and the schedule to start our planned study," Punit Dhillon, CEO and Chair of Skye said in a statement.
"Securing approval for the Australian Human Research Ethics Committee at the end of June was a vital factor to move our Phase 1 forward. While the delay in the Phase 1 is not a welcomed outcome, we are pleased that we continue to progress on the logistics that move us toward enrollment and dosing of the first cohort of patients," he added.
While the contract manufacturer has sufficiently recovered from the recent cyber-attack, planned annual facility maintenance could not be rescheduled, Skye said, adding that the maintenance schedule has been accelerated and will be conducted through to August 30.
Skye's SBI-100 product is now planned to be produced and filled in the first week of September, with required drug quality testing completed by the first half of October.
"As we previously noted, we are in parallel progressing our Phase 2 clinical development plan. In our preliminary meeting last winter with the FDA to discuss our planned Investigational New Drug (IND) application, the FDA confirmed that, as is standard practice with all ophthalmology clinical studies, it would accept from Skye nonclinical toxicology data for review and approval of its IND and Phase 2 protocol rather than requiring Phase 1 safety data,” Dhillon said.
“The Phase 1 study outcome will provide us the benefit of safety and tolerability data of SBI-100 OE but is not a gating factor to initiate Phase 2. We continue to look forward to obtaining Phase 1 data but concurrently developing our clinical plans with the expectation that we can report Phase 2 by year-end 2023," he concluded.
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 OE, is focused on developing a treatment for glaucoma, the world's leading cause of irreversible blindness.
Contact the author at jon.hopkins@proactiveinvestors.com