Skye Focuses on Nimacimab Metabolic Program Strategy and Clinical Development

Skye Bioscience(Nasdaq: SKYE), a company focused on the discovery, development, and commercialization of drugs that modulate the endocannabinoid system, has announced the discontinuation of its SBI-100 Ophthalmic Emulsion (OE) program. The decision follows the Phase 2a clinical trial results, which failed to meet the primary endpoint of lowering intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT).

Phase 2a Trial Findings

The Phase 2a study of SBI-100 OE involved 56 patients diagnosed with either POAG or OHT. Participants received one drop of 1.0% or 0.5% concentrations of SBI-100 OE or a placebo in each eye twice daily for 14 days. The trial's primary goal was to assess changes in diurnal IOP in the treated groups compared to the placebo group. Unfortunately, the study did not show a statistically significant improvement in IOP over the placebo. Despite the disappointing efficacy results, the drug was found to be safe, with no early discontinuations due to adverse events.

Strategic Shift to Metabolic Program

Following the unsatisfactory trial results, Skye Bioscience has decided to cease all development and spending related to SBI-100 OE and its associated ophthalmology pipeline. The company will now redirect its focus and resources towards its metabolic program, which has been designed to diversify its product portfolio and expand clinical and business opportunities.

Nimacimab: The New Focus

Skye’s attention will now be concentrated on Nimacimab, a unique CB1 inhibitor designed to address metabolic conditions. Nimacimab is a first-in-class humanized monoclonal antibody that negatively modulates CB1 signaling in the periphery. This inhibition has shown potential to address various diseases with significant unmet medical needs, such as obesity, chronic kidney disease, and metabolic dysfunction-associated steatohepatitis (MASH).

The Phase 2 obesity clinical trial for Nimacimab is scheduled to begin in the third quarter of 2024. Skye plans to evaluate both monotherapy and combination therapy using Nimacimab alongside a GLP-1R agonist, aiming to achieve sustainable weight loss and improved treatments for co-morbid conditions.

Future Prospects

With this strategic pivot, Skye Bioscience aims to leverage its expertise in the endocannabinoid system to develop first-in-class therapeutics that address significant clinical and commercial needs. The company's focus on metabolic, inflammatory, and fibrotic diseases positions it to make substantial contributions to these areas of unmet medical need.

The discontinuation of the SBI-100 OE program allows Skye to extend its cash runway into 2027, providing the financial stability needed to advance Nimacimab and other potential therapies in its pipeline. As Skye moves forward, it remains committed to unlocking the pharmaceutical potential of the endocannabinoid system to improve patient outcomes across various therapeutic areas.

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