Clinuvel (ASX:CUV) Announces Positive Preliminary Stroke Study Results
Clinical Study Results
Clinuvel Pharmaceuticals Ltd (ASX: CUV) completed its CUV803 study involving nine arterial ischaemic stroke patients treated with PRÉNUMBRA® Instant. The goal of the study was to evaluate the safety of afamelanotide in stroke patients. The treatment was well tolerated, with only mild and transient adverse events reported. By day 42, eight out of nine patients (88.9%) showed functional improvement, and six patients (66.7%) demonstrated radiological improvement or stability. Two of the three patients with moderate to severe stroke passed away; however, this was determined to be due to complications unrelated to afamelanotide treatment.
Executive Comments
“While considerable progress has been made in treating stroke with approved therapies, a large number of patients remain ineligible for existing therapies,” Clinuvel’s Chair, Prof Jeffrey Rosenfeld said.
He continued “Afamelanotide represents an innovative approach, taking a drug with a long-standing safety profile and evaluating whether a known mechanism of action may provide a therapeutic option for these previously untreated patients. With the CUV801 and CUV803 studies we have generated a small, but encouraging, data set that demonstrates the drug’s safety profile in patients with strokes of varying degrees of severity, as well as first indications that patients may benefit from treatment. While the stroke program is not an immediate focus for the business, I expect our teams will be able to use these data to support future decision making that may result in positive outcomes for patients.”
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