Glowing Phase II results for Clinuvel

Those with the rare skin disorder, solar urticaria (SU), are a step closer to having a treatment following the announcement today from Clinuvel Pharmaceuticals of positive results from a Phase II study of its drug afamelanotide in treating the ailment.

SU is a skin disorder marked by an acute allergic response following UV or Sun exposure. Symptoms can be systemic, such as anaphylaxis, breathing difficulty, nausea and headaches. Immediate localised reactions vary from characteristic ‘wheal’ formation and erupting flares on exposed skin sites, to swelling of soft tissues.

Current available treatment is only partially effective and consists of anti-histamines, immunotherapy and plasmapheresis (blood purification). It is estimated that 3-4 people per 100,000 suffer from SU worldwide.

The study was conducted at Manchester Hope Hospital in the United Kingdom and involved five patients who were administered Clinuvel's photoprotective drug, afamelanotide. All patients experienced an increase in tolerance of the skin to light of various wavelengths and intensities.

The size and intensity of skin reactions and wheal formation was significantly reduced (p<0.003) at 30 and 60 days following dosing of afamelanotide. Importantly, the Minimal Urticarial Dose (MUD), a scientific measurement of tolerance to UV and sunlight in SU, was significantly increased (p<0.001) in all patients at 30 and 60 days. These results indicate that afamelanotide may reduce the risk of incapacitating reactions to UV and sunlight in SU patients.

“Today’s unequivocal results give further support to the use of afamelanotide as a medicinal photoprotective drug in patients who are gravely affected by UV and sunlight,” Clinuvel’s Chief Scientific Officer, Dr Hank Agersborg, said. “Clinuvel will now accelerate its program in Solar Urticaria worldwide and apply for permission to start Phase III confirmatory controlled trials.” In January of this year Clinuvel received investigational new drug status for afamelanotide from the Food and Drug Administration in the US and posted positive results from a Phase III trial of the drug in Switzerland.

Clinuvel's share price (ASX:CUV) lifted 3% to $0.325 in morning trading following the announcement.