US-based biopharma Silver Creek Pharmaceuticals’ late intervention acute ischemic stroke candidate, SCP-776, has demonstrated varied results in a mid-stage trial.
During the Phase II ARPEGGIO (NCT05585606) study, Silver Creek’s targeted insulin-like growth factor 1 (IGF-1) fusion protein offered a 2.26-point boost to NIH Stroke Scale (NIHSS) scores by discharge or seven days after onset.
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Though the drug did impact NIHSS rankings, this effect was not statistically significant, achieving a p value of 0.066, which narrowly misses the 0.05 significance threshold.
Meanwhile, 15% more patients in the SCP-776 group achieved functional independence compared with the placebo cohort. Silver Creek determined if a patient was functionally independent by their modified Rankin Scale (mRS) score, which had to be between 0 and 2 after 90 days to qualify.
mRS is a six-point scale that is commonly used in stroke clinical studies to measure a patient’s degree of disability and subsequent dependence on care. Scores of 2 or less indicate mild-to-no disability, with symptoms improving as values lower.
The drug was proven safe and tolerable, with treatment-emergent adverse events (TEAEs) occurring at similar rates across the SCP-776 and placebo groups. The drug’s most common side effect was hypoglycaemia, which Silver Creek noted was “well managed” in patients.
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By GlobalDataThese results were presented at the 2025 World Stroke Congress in Barcelona, Spain, between 22 and 24 October.
In a 23 October statement, Silver Creek stated that the ARPEGGIO trial’s outcome could mark “a potential breakthrough” in stroke care, as there are no pharmacological interventions approved for the late intervention patient subset.
Serving unmet needs in stroke recovery
While stroke outcomes are on the up due to advancements in reperfusion therapies, there is still a distinct lack of therapeutic options for late intervention window patients outside of thrombolysis and mechanical thrombectomy.
These procedures can also be associated with poor outcomes, as they can trigger haemorrhages or even the worsening of stroke symptoms in certain patients.
As there are a distinct lack of approved drugs available in this indication, certain companies such as Silver Creek have started developing drugs that can help improve outcomes post-stroke.
This significant unmet need led the US Food and Drug Administration (FDA) to grant Silver Creek fast track designation for SCP-776 in October 2025.
However, the company is not alone in its mission to get a drug to market in the late-window population. Revalesio is looking to take its oxygen-enriched saline product, RNS-60, to Phase III in both early and late-window patients. This follows positive Phase II data, which shows that the drug can reduce brain tissue loss and improve functional outcomes.
Outside of the late-window setting, Roche-owned Genentech’s tissue plasminogen activator, TNKase (tenecteplase) recently became the first drug to get the FDA green light in ischemic stroke in nearly three decades. This medication is suitable for use up to three hours after onset, though some physicians prescribe it off-label after longer periods.
This approval extended Genentech’s legacy in ischemic stroke, as it became the first company to market a drug in the indication in Activase (alteplase) back in 1996.
According to GlobalData’s Intelligence Center, there are currently 19 drugs in Phase III trials for acute ischemic stroke across Europe and North America.
GlobalData is the parent company of Clinical Trials Arena.
