Skye Bioscience ends clinical development of SBI-100 Ophthalmic Emulsion

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All R&D for the drug will stop after the Phase 2a clinical trial failed to meet its primary endpoint of lowering IOP in patients with primary open-angle glaucoma.

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Skye Bioscience announced it intends to discontinue clinical development and spending related to SBI-100 Ophthalmic Emulsion.

This decision follows the announcement that SBI-100 OE failed to meet its primary endpoint of lowering intraocular pressure in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT) in a Phase 2a clinical trial.¹

The company also stated in a press release that any R&D associated with SBI-100 OE will be discontinued, including its ophthalmology pipeline. All clinical development resources will be shifted to the company’s metabolic program.¹

In the Phase 2a clinical trial of SBI-100 OE, 56 patients with elevated IOP diagnosed with POAG or OHT received dosing of 1.0% or 0.5% concentrations of SBI-100 OE or placebo. According to the company, “the study did not achieve a statistically significant improvement in IOP over placebo, [however], the drug was safe and all treated patients completed the study with no early discontinuations due to adverse events.”

Tu Diep, Skye’s Chief Development Officer talked about the results in a release from the company stating, “The results of this Phase 2a clinical trial of SBI-100 OE unfortunately did not meet our pre-set criteria for continuation and further development of this molecule as an alternative treatment for glaucoma and ocular hypertension. We will continue to evaluate the full data set and intend to publish findings. We thank the patients and investigators who supported our clinical investigation of SBI-100 OE in this study.”

Skye’s Phase 2 obesity clinical trial for its differentiated CB1 inhibitor, Nimacimab, is expected to begin dosing in Q3 2024.¹