Clinuvel completes enrolment in world-first stroke study

Latest News

Clinuvel (ASX:CUV) has completed enrolment in its study of afamelanotide as a treatment for patients with arterial ischaemic stroke.

The company said afamelanotide was well tolerated by all patients with no adverse drug reactions reported.

Afamelanotide is thought to offer neuroprotection and act as a potent anti-oxidative hormone. It also activates vessels, reducing fluid formation, protecting critical nerve and brain tissue, and restoring the blood-brain barrier.

“Safety is and remains our primary focus in the stroke program study, given the novelty of the application of our technology and the diversity and severity of symptoms stroke patients can experience,” said Clinuvel's head of clinical operations, Dr Pilar Bilbao.

“The safety profile reported to date gives us much comfort to continue the program, which seeks to evaluate afamelanotide as a safe, effective treatment for the millions of AIS patients who lack therapeutic alternatives.”

Stroke is the second most common cause of death and a leading cause of disability worldwide. Yet many stroke patients are unsuitable to receive the current standard of care - clot removal and clot dissolution.

AIS accounts for approximately 85 per cent of the 15 million strokes suffered worldwide each year. 

The phase 2 study of afamelanotide study (CUV801) focuses on treating adult AIS patients who are ineligible for the current standard of care.

"All six AIS patients treated under the CUV801 protocol are being evaluated for up to six weeks at a specialist neurological hospital in Australia, with clinical assessments made to detect changes or improvement in neurological functions and activities of daily living," said the company.
“We eagerly await completion of the CUV801 study and analysis of final results in 2022. Clinical observations and learnings from CUV801 are already helping us to design the next studies, with the hope that afamelanotide can be administered to a wider population of stroke patients who lack treatment,” added Dr Bilbao.