• Nine patients with mild, moderate and moderate-to-severe stroke treated with PRENUMBRA® Instant
• Treatment well tolerated with mild and transient adverse events
• Functional improvement in 88.9% of patients at day 42
• Radiological improvement or stability in 66.7% of patients

Clinuvel Pharmaceuticals Ltd has released positive preliminary results from its CUV803 study investigating the use of its drug afamelanotide (PRENUMBRA® Instant) in the treatment of arterial ischaemic stroke (AIS) patients ineligible for standard of care intravenous thrombolysis (IVT) or endovascular thrombectomy (EVT). The study enrolled nine adult patients with mild (n=3), moderate (n=3) and moderate-to-severe (n=3) AIS, who were administered PRENUMBRA® Instant daily for up to five days. The primary endpoint was to evaluate the safety of afamelanotide, which was shown to be well tolerated with all treatment-related adverse events being mild and transient. Two of the three patients with moderate-to-severe stroke passed away due to complications unrelated to the treatment. Secondary endpoints evaluated the impact of afamelanotide on neurological functions, with eight out of nine patients (88.9%) demonstrating an improvement in initial stroke symptoms and neurological disability by day 42. Brain imaging analysis also showed a decrease or stabilisation of infarct size in six of nine patients (66.7%) up to 42 days after treatment. These results are consistent with data from the earlier CUV801 study evaluating afamelanotide in AIS patients. While the stroke program is not an immediate focus, Clinuvel plans to use these data to support future decision making that may result in positive outcomes for patients.