Skye Bioscience, Inc. has completed enrollment—including dosing and all final study patient visits—for its phase 2a clinical study evaluating SBI-100 ophthalmic emulsion (OE) for the treatment of primary open-angle glaucoma (POAG) and ocular hypertension (OHT).
Refresh me on SBI-100.
SBI-100 OE is a cannabinoid receptor type 1 (CB1) agonist formulated as an eye drop and administered topically into the eye via nanoemulsion.
As a prodrug of tetrahydrocannabinol (THC), the new, synthetically-derived molecule is designed to target the CB1 receptor, which can modulate intraocular pressure (IOP).
Now let’s talk phase trial 2 design.
The double-masked, randomized, placebo-controlled study (NCT06144918) was designed to enroll 54 patients (aged 18+) with POAG or OHT who were also diagnosed with elevated IOP.
Participants were randomly assigned to an interventional treatment of one of the following:
- 0.5% SBI-100 OE (5 mg/mL)
- 1.0% SBI-100 OE (10 mg/mL)
- Placebo
And the dosing schedule?
One drop of one of the three interventions was administered in each eye, twice a day (BID)—morning and evening—for 14 days.
No specifics have been released on the number of participants in each of the three treatment groups.
What’s being measured?
According to Clinical Trials, primary outcome measures include:
- Ocular hypotensive efficacy of two dose levels of SBI-100 OE
- Measured at baseline and day 14
- Ocular and systemic safety
- Measured at baseline up to day 16
Secondary outcomes include:
- Ocular hypotensive efficacy at individual timepoints
- Measured at baseline and day 14
- Application comfort
- Measured at baseline up to day 16
How have patients reacted so far?
Per Skye Bioscience, all 54 participants have completed the study, “with no early discontinuations due to adverse events (AEs).”
So … is positive data expected from this?
Based on the promising results from the company’s phase 1 trial on SBI-100 OE, I’d say so. “We received encouraging results from our phase 1 clinical trial and look forward to the efficacy data from our SBI-100 OE CB1 agonist,” stated Tu Diep, Skye’s chief development officer, “which will be the first-ever data from this therapeutic class in a standardized clinical trial setting."
Tell me about that data.
Back in February 2023, Skye received a positive safety review for the dosing of a second cohort for its phase 1 study on SBI-100 OE.
A safety review committee (SRC) found SB-100 OE to be well-tolerated in the second cohort, with only mild adverse events (AES) reported.
And in October 2023, the company reported that SBI-100 OE was deemed safe, well-tolerated, with no drug-related serious AEs and “treatment-related AEs were consistent with topically-applied eye treatments.”
What about IOP?
Among the 48 participants, SBI-100 OE was found to reduce IOP (with a 23% mean reduction) in healthy volunteers with higher baseline IOP ( >17 mm Hg).
Interesting. Now back to this phase 2 study: When can we expect data?
Clinical Trials reports that the study is slated to conclude by December 2024.
Per Diep, topline data is expected to be released by Q2 2024.