Clinuvel Pharmaceuticals’ (ASX: CUV: ADR: CLVLY) Phase III clinical study has demonstrated that its SCENESSE® drug improves the ability of patients with a rate light intolerance disorder to expose their skin to light.
The six-month, randomised, multicentre, double‐blind, placebo‐controlled study (CUV039) was carried out on 87 adult erythropoietic protoporphyria (EPP) patients in seven centres across the U.S.
This found that patients receiving SCENESSE® (afamelanotide) tolerated median total direct sunlight exposure of 64.13 hours compared to the 47.5 hours for placebo recipients.
In addition, treated patients reported more days when they had pain‐free exposure of 60 minutes or more.
EPP is a rare genetic disease found mainly in fair‐skinned people. It is characterised by severe phototoxicity (intolerance to light) of the skin, resulting in intolerable pain, swelling and scarring, usually of exposed areas such as the face, hands and feet.
Symptoms can vary from mild to extreme lasting pain requiring hospitalisation.
Patients often lead an indoor and sheltered life, avoiding light exposure to prevent symptoms.
Thus far, no serious safety concerns have been identified from the use of afamelanotide in more than 900 patients, including over 300 EPP patients.
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