Leading pharmaceuticals company CLINUVEL (ASX: CUV) is set to commence human trials using the drug afamelanotide to dissolve or remove underlying blood clots in the brain that cause arterial ischaemic stroke (AIS) which accounts for 85% of the 15 million strokes suffered worldwide each year. 

Current stroke therapies are reliant on early intervention to restore blood flow to the brain with CLINUVEL’s research indicating that afamelanotide may rapidly exert its effects to protect brain tissue, act on blood vessels to optimise blood flow, and reduce the size of swelling in the brain following a stroke.

“Stroke is most commonly caused by a clot in a patient’s brain which starves surrounding tissue of blood and essential oxygen, causing the destruction of brain cells,” said  CLINUVEL Chief Scientific Officer, Dr Dennis Wright. 

“This brain damage can have an irreversible effect on a patient’s ability to speak, move, and function, and tragically leads to an early death for more than 5.5 million people per annum. 

“It is our aim to show that treatment with afamelanotide can safely reduce and prevent brain damage in the majority of stroke patients who cannot be offered standard therapy.” 

Although the afamelanotide human trials will be the first of their kind for stroke patients, the drug is approved in the United States and Europe to treat erythropoietic protoporphyria (EPP), a rare metabolic disorder, for almost 20 years.

For their human trials, CLINUVEL will administer SCENESSE® (an afamelanotide product that has just been approved by the Therapeutic Goods Association) to six patients that have clots located in the higher segments of the brain and are ineligible for alternative treatments. Once administered, the six patients will be monitored with CT scans and MRI scans to measure changes in neurological and cognitive function. 

“Having monitored the real world use of SCENESSE® in patients in Europe and the USA, we have now collected sufficient safety data to further our clinical programs in life threatening disorders. We look forward to the first study results in the first half of 2021, but also depending on the capacity of hospitals due to the COVID pandemic,” said Dr Wright.