CLINUVEL's positive results for SCENESSE® in treating variegate porphyria patients

CLINUVEL Pharmaceuticals Limited (ASX: $CUV) has reported positive outcomes from its Phase II study, CUV040, evaluating the efficacy of SCENESSE® (afamelanotide 16mg) in treating variegate porphyria (VP) patients. The study demonstrated that SCENESSE® provides systemic photoprotection, reduces disease severity, and improves the quality of life for VP patients over a six-month treatment period.

Executive commentary on SCENESSE® study results

Today's results show a further indication of the potential of SCENESSE® to offer photoprotection for those patients affected by light and UV, providing patients a new life. As a pilot study in VP, we have looked at a range of endpoints to understand the impact of the disease, how it presents in the clinic, and how we may be able to evaluate the photoprotective effect of novel treatment. These results give us the momentum to continue the development program for VP, establishing a larger clinical trial program and subsequently preparing and filing a marketing authorisation application.

Summary of SCENESSE® study results and outlook

CLINUVEL's Phase II study, CUV040, has demonstrated the efficacy of SCENESSE® in providing systemic photoprotection, reducing disease severity, and improving the quality of life for variegate porphyria (VP) patients over a six-month treatment period. The positive outcomes indicate the potential for SCENESSE® to address the unmet medical need in VP, where there are currently no approved treatments for the dermatological symptoms. The company aims to continue the development program for VP, including establishing a larger clinical trial program and preparing a marketing authorisation application. SCENESSE®'s positive safety profile and the significant improvements observed in disease severity and patient quality of life provide a promising outlook for the future of VP treatment.