Skye banks on anti-obesity antibody after glaucoma drug setback
10 Jun 2024
Phase 2Clinical Result
Skye Bioscience is discontinuing its SBI-100 ophthalmology programme after the treatment came up short in a Phase IIa study of patients with primary open-angle glaucoma or ocular hypertension.
The company, whose shares were down 25% in premarket trade on Monday, will now focus efforts on trying to make headway in the ultra-competitive anti-obesity market by advancing its sole remaining pipeline candidate nimacimab, a move expected to stretch its cash runway into 2027. The pivot follows Skye's recent uplisting to the Nasdaq exchange.
"In the last year, we laid the groundwork for our metabolic programme with the goals of diversifying our product portfolio's disease targets and therapeutic mechanisms, while significantly expanding our clinical and business opportunities," remarked CEO Punit Dhillon. "With this data outcome from our glaucoma programme, we will now focus 100% of our efforts on broadening our metabolic clinical pipeline."
The randomised Phase IIa study evaluated SBI-100 ophthalmic emulsion at two concentrations in 56 patients over 14 days of twice-daily dosing. Skye said the study did not achieve statistically significant reductions in diurnal intraocular pressure compared to placebo. The treatment was considered safe with no treatment discontinuations due to adverse events.
Nimacimab data in 2025
Nimacimab is designed as a negative allosteric modulator to inhibit cannabinoid 1 receptor (CB1) signalling in the periphery. Dhillon said the drug's "unique mechanism of peripheral CB1 inhibition positions it to potentially contribute to the need for higher-quality, sustainable weight loss and better treatments for co-morbid conditions amidst an incretin-biased anti-obesity therapeutic landscape."
A Phase II trial evaluating nimacimab in obesity, including monotherapy and combination arms with a GLP-1 agonistGLP-1 agonist, is expected to begin dosing in the third quarter. The biotech previously said it planned to begin a mid-stage study of the drug in obesity and chronic kidney disease in the first half. "We will look forward to sharing updates on this clinical programme and advancing nimacimab through to data in 2025," the CEO added.
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