Clinuvel initiates second trial of new anti-stroke candidate

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Australian company Clinuvel has initiated its second stroke trial with the first patient administered its new PRÉNUMBRA Instant (afamelanotide) formulation.

The new formulation is being trialled in the Phase 2 safety and efficacy study (CUV803) in patients who have suffered an arterial ischaemic stroke (AIS) and are ineligible for the standard of care. Standard of care consists of either intravenous thrombolysis (IVT) or endovascular thrombectomy (EVT).

AIS is caused by an arterial clot blocking the blood supply to the brain. The resulting lack of oxygen and glucose causes immediate tissue death, with a larger area of the surrounding brain at risk of further damage, due to fluid formation and inflammation. Patients suffer irreversible damage which, if not fatal, often leads to the permanent loss of mobility and/or speech.

AIS accounts for around 85 per cent of the 15 million strokes incurred globally each year, with an estimated 70 to 80 per cent ineligible for treatment with IVT or EVT.

The company said that up to 12 adult patients will be enrolled, consisting of six patients with mild to moderate, and six with moderate to severe stroke, as reflected by the National Institutes of Health Stroke Scale.

“Afamelanotide has the potential to reduce the impact of stroke and prevent further brain damage,” said Clinuvel's head of clinical operations, Dr Pilar Bilbao.

“We advance some key learnings from the first study and try to explore the clinical benefits of a flexible dose of afamelanotide in CUV803.

“Given the paucity of available therapies for the majority of stroke patients, the opportunity to provide a new treatment option is great. By being diligent and vigilant, we advance clinical management of stroke.”

Clinuvel said the new afamelanotide formulation, PRÉNUMBRA Instant, allows physicians to make faster dosing decisions and has the potential to deliver a faster clinical response.

In 2022, the first study in AIS, CUV801, five of six patients diagnosed with a mild to moderate stroke showed improved neurological function following afamelanotide, administered as a controlled-release implant. The treatment was also well tolerated.