The following is a summary of “A feasibility and safety study of afamelanotide in acute stroke patients – an open label, proof of concept, phase iia clinical trial,” published in the July 2023 issue of Neurology by Stanislaus et al.
Afamelanotide is a potential neuroprotective agent for acute ischemic stroke (AIS) patients. Researchers performed a prospective study assessing the neuroprotective benefits of Afamelanotide in acute ischemic stroke (AIS) patients, including revascularization recipients and ineligible cases.
They enrolled AIS patients within 24h onset, with imaging perfusion abnormality (Tmax), ineligible for revascularization. Afamelanotide, 16 mg implants, was administered subcutaneously on D0 (D0, day of recruitment), D1, D7, and D8—regular recording of Treatment-Emergent Adverse Events (TEAEs) and neurological assessments up to D42. Magnetic resonance imaging (MRI) with FLAIR sequences was performed on D3 and D9.
The results showed 6 patients (5 women, median age 81, median NIHSS 6) receiving Afamelanotide. Out of 2 patients who had 4 doses, and 4 had 2 doses & 1 patient (2 doses) suffered a fatal recurrent stroke on D9 due to a known occlusion deemed unrelated to the drug.
No other local or systemic TEAEs were recorded. Surviving patients showed NIHSS improvement from 6 to 2 on D7. Median Tmax volume on D0: 23 mL, reduced to FLAIR volume of 10 mL on D3 and 4 mL on D9. Investigators concluded that Afamelanotide showed good tolerability and safety in a small sample of AIS patients.
Source: bmcneurol.biomedcentral.com/articles/10.1186/s12883-023-03338-9
