A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS)

Summary

The primary study objective is to assess the safety of afamelanotide while the secondary objective is to assess whether the therapy affects the size of the penumbra, by increasing blood flow, restoring oxygen supply to the brain, and reducing the amount of cerebral oedema (fluid) which is seen as a result of the stroke. Positive findings would indicate that the drug is able to support brain tissue-at-risk and provide overall neuroprotection and benefit to stroke patients.

Timeline

Start

2021-06-03

Primary completion

2022-02-04

Completion

2022-02-04

Outcome

Met primary endpoint

release “The primary endpoint of the CUV803 study was to evaluate the safety of afamelanotide in stroke patients. The drug was shown to be well tolerated” clinuvel.com ↗

Publications

• Stanislaus V, Kam A, Murphy L, Wolgen P, Walker G, Bilbao P, Cloud GC. A feasibility and safety study of afamelanotide in acute stroke patients - an open label, proof of concept, phase iia clinical trial. BMC Neurol. 2023 Jul 26;23(1):281. doi: 10.1186/s12883-023-03338-9.

Drugs

Indications