Source: Clinuvel Pharmaceuticals
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  • Clinuvel Pharmaceuticals (CUV) confirms its pilot study, CUV801, has delivered positive results of the company’s drug afamelanotide in treating arterial ischaemic stroke
  • CUV801 evaluated multiple doses of the drug in six adult patients, with five of the six showing considerable clinical and functional recovery up to 42 days after treatment
  • Analyses of the brain scans (MRI-FLAIR) performed at days three and nine shows a reduction in size of the affected area in five of the six patients
  • Additionally, all five surviving patients shows an improvement in neurological functions and reduction in overall impairment
  • CUV shares are down 0.56 per cent, trading at $16.05

Clinuvel Pharmaceuticals (CUV) confirmed its pilot study, CUV801, has delivered positive results of the company’s drug afamelanotide in treating arterial ischaemic stroke (AIS).

CUV801 evaluated multiple doses of the drug in six adult patients, with five of the six showing considerable clinical and functional recovery up to 42 days after treatment.

All six patients enrolled in the study carried an increased risk of stroke due to their history of cardiovascular disease, elevated blood pressure or diabetes type II, and all suffered a stroke, or blood clot, in the left half of the brain.

The afamelanotide was administered up to four times over ten days following the stroke which did not seem to affect patient safety, with no drug-related adverse events reported during or after study completion.

Notably, the company reported that one patient with a complex cardiovascular history passed away following a second stroke on day 5. Clinuvel, however, said the passing was assessed as unrelated to the afamelanotide treatment.

Analyses of the brain scans (MRI-FLAIR) performed at days three and nine showed a reduction in size of the affected area in five of the six patients.

Additionally, all five surviving patients showed an improvement in neurological functions and reduction in overall impairment.

“Final analyses from the CUV801 study show that surviving patients who received treatment with afamelanotide all seemed to have recovered well in the six weeks following their brain injury,” Head of Clinical Operations Dr Pilar Bilbao said.

“The significance of these findings is of benefit to all our current and future programs.”

Four out of the five surviving patients showed an improvement of four points or more on the scale and all five patients reported a clinically meaningful reduction of three points.

Two patients were symptom free at day 42.

The company hopes to address the as-yet unmet medical need in ischaemic strokes with its afamelanotide drug.

“We are seeking to prove that afamelanotide can provide a safe, effective treatment option which can improve the overall prognosis post-stroke and reduce patient disability long-term,” said Dr Bilbao.

“With CUV801 we have achieved both these outcomes and can now pursue further studies and regulatory interactions with a degree of confidence that the drug performs as expected.”

CUV shares were down 0.56 per cent, trading at $16.05 as of 10:17 am AEST.

CUV by the numbers
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