Clinuvel (ASX:CUV) has released preliminary results from its second clinical study investigating its drug afamelanotide as a treatment for arterial ischaemic stroke (AIS).
The company said the CUV803 study enrolled nine adult patients with mild (n=3), moderate (n=3) and moderate-to-severe (n=3) AIS at two European specialist stroke treatment units. All patients who were not eligible for standard-of-care intravenous thrombolysis (IVT) or endovascular thrombectomy (EVT) were administered PRÉNUMBRA Instant (afamelanotide) daily for up to five days.
The primary endpoint of the CUV803 study was to evaluate the safety of afamelanotide in stroke patients. Clinuvel said the drug was well tolerated in all nine participants. "All treatment-related adverse events were mild, transient, and consistent with the established safety profile for afamelanotide," it said, adding two of the three patients with moderate-to-severe stroke (NIHSS scores 17 and 19) passed away due to complications unrelated to afamelanotide treatment. One of these patients died two months after the study's completion.
Secondary endpoints sought to evaluate the impact of afamelanotide on neurological functions. By day 42, eight out of nine patients (88.9 per cent) demonstrated an improvement in initial stroke symptoms and neurological disability following treatment with afamelanotide, as measured by reduced NIHSS and functional disability scores. Analysis of brain imaging (MRI) showed that the infarct size had decreased or stabilised in six of nine patients up to 42 days after treatment, said Clinuvel.
The company said fifteen AIS patients had been evaluated as part of the program, either receiving afamelanotide as a subcutaneous injectable implant or liquid).
"Review of the data globally suggest the safety profile of afamelanotide in AIS is consistent with that seen in other patient groups. Thirteen of the AIS patients treated with afamelanotide (86.7 per cent) demonstrated functional improvement, while ten (66.7 per cent) showed a reduction or stabilisation of infarct size up to 42 days after treatment," said Clinuvel.
"While considerable progress has been made in treating stroke with approved therapies, a large number of patients remain ineligible for existing therapies,” said Clinuvel's chair, Professor Jeffrey Rosenfeld. “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,” said Professor Rosenfeld.