Skye Bioscience ends eye disease R&D efforts after glaucoma drug's phase 2 fail

10 Jun 2024
www.fiercebiotech.com
Phase 2
Skye Bioscience ends eye disease R&D efforts after glaucoma drug's phase 2 fail
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Source: FierceBiotech
Skye will not only halt all work on SBI-100 but end its ophthalmology R&D ambitions entirely.
Skye Bioscience’s share price tumbled in pre-market trading Monday, as the biotech announced a strategic refocus in the wake of a phase 2 trial failure.
The company’s stock dropped by 28% to $7.90 as of 8:15 a.m. ET on Monday, compared to a Friday closing price of $10.94 after the biotech disclosed that its lead asset, a cannabinoid receptor-1 (CB1) agonist called SBI-100, failed to demonstrate a statistically significant lowering of intraocular pressure in a mid-stage trial across 56 patients with primary open-angle glaucoma or ocular hypertension.
As recently as April, Skye had been attributing its work getting SBI-100 into the phase 2 trial—which completed dosing in February—as one of the reasons for being able to bounce its shares from the over-the-counter securities market to the Nasdaq Global Market.
But in response to today’s clinical fail, Skye will not only halt all work on SBI-100 but end its ophthalmology R&D ambitions entirely. From now on, all resources are being funneled into the company’s metabolic program, which is headed up by CB1 inhibitor nimacimab.
A phase 2 trial of nimacimab in obesity is due to begin dosing in the third quarter and Skye said the strategic pivot would extend its operating runway into 2027.
The company had already “laid the groundwork for our metabolic program” over the last year, according to CEO Punit Dhillon, with the aim of “diversifying our product portfolio’s disease targets and therapeutic mechanisms.”
“With this data outcome from our glaucoma program, we will now focus 100% of our efforts on broadening our metabolic clinical pipeline,” Dhillon added in the June 10 release. “We believe that nimacimab’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.”
“We will look forward to sharing updates on this clinical program and advancing nimacimab through to data in 2025,” the CEO added.
Inhibiting CB1 has shown potential to address a “broad range of diseases with notable unmet medical needs” including obesity, chronic kidney disease and metabolic dysfunction-associated steatohepatitis (MASH), the biotech noted in the release.
However, the modality doesn’t have a great track record. In fact, CB1 agonists have been tied to one of the biggest pharma flops of recent decades, when Sanofi and Aventis’ obesity drug Acomplia was pulled from European markets in 2008 over risks of depression and suicidal thoughts.
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