Clinuvel Pharmaceuticals (ASX:CUV) has reported encouraging preliminary results from its second study of afamelanotide in stroke patients, showing functional improvement in most participants.
The CUV803 trial tested PRÉNUMBRA Instant—a liquid formulation of afamelanotide—in nine European patients with mild to moderate-to-severe arterial ischaemic stroke who were ineligible for standard treatments such as intravenous thrombolysis or thrombectomy.
The drug was administered daily for up to five days. Eight of the nine patients showed improvement in neurological function after 42 days, while six demonstrated stabilised or reduced infarct size on MRI scans. All treatment-related side effects were mild and transient.
Two patients with severe strokes died due to complications deemed unrelated to the treatment. The remaining patients tolerated the drug well, reinforcing findings from Clinuvel’s earlier implant-based study, CUV801.
Clinuvel has now studied afamelanotide in 15 stroke patients, with 87% showing functional improvement and 67% showing radiological stability or improvement.
Chairman Professor Jeffrey Rosenfeld said the results offered an early indication of benefit in patients lacking other options, but added the stroke program was not a current priority. The company is focusing its resources on commercial and clinical development in vitiligo, porphyrias, and other melanocortin-based therapies.
Shares are trading 1.97% higher at $11.93.
