Skye Bio to refocus as SBI-100 misses primary goal
Shares of Skye Bioscience (Nasdaq: SKYE) fell as much as 25% in pre-market activity on Monday, after it revealed that its Phase IIa clinical trial of SBI-100 ophthalmic emulsion (OE) in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT) did not meet its primary endpoint for lowering intraocular pressure (IOP).
As a result, Skye said it intends to discontinue clinical development and spending related to SBI-100 OE and any R&D associated with SBI-100, including its ophthalmology pipeline, and direct all clinical development resources to its metabolic program, extending its operating runway into 2027. Skye’s Phase II obesity clinical trial for its differentiated CB1 inhibitor, nimacimab, is expected to begin dosing in third quarter 2024.
Study findings
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