Scenesse One Step Closer for Erythropoietic Protoporphyria (EPP)

Written by on November 4, 2011 in Scenesse (Afamelanotide Implant 16mg) with 0 Comments


News from Clinuvel that Scenesse (their implant of afamelanotide 16mg) has shown a provable positive effect on EPP sufferers in a US Phase 2 Trial.

EPP is an acute intolerance to exposure to sunlight and UV. Sufferers of EPP describe the disease as crippling.

As has been the case in other blinded trials, the study centres have requested the supply of more Scenesse to continue to treat their happy participants.

Scenesse has been granted Orphan drug status, meaning that it can be submitted as a possible treatment for the rare disease Erythropoietic Protoporphyria.

What About Rosacea Sufferers?

Rosacea sufferers who cannot tolerate the sun will be heartened by EPP sufferers being able to spend more time outside during the most intense UV exposure hours.

These latest results confirm that Scenesse continues to track slowly but surely towards approval as a photoprotective agent for EPP.

Clinuvel demonstrates positive treatment effect of  afamelanotide in US Phase II study 

Analyses from US confirmatory study demonstrate a dramatic improvement in Quality of Life from SCENESSE® (afamelanotide 16mg) in the ‘orphan’ disease erythropoietic protoporphyria (EPP)

Melbourne, Australia and Baar, Switzerland, November 3, 2011

Seventy-seven patients started the study and 68 completed study medication and all clinical visits.  In total 12,254 days were evaluated during the six month study. An adaptive and compound statistical analysis was performed. Results of the study showed that SCENESSE® was well tolerated, allowed EPP patients to expose their skin  to sunlight during the middle of the day and improved their Quality of Life (QoL).  Overall the study demonstrated a strong clinical benefit to patients, despite their deeply learned behaviour to avoid reactions caused by sun exposure.

Overall, EPP patients who received afamelanotide (active drug) were able to spend more time in direct sunlight between 10 AM and 3 PM and 10 AM and 8 PM (p=0.036, p=0.025) in comparison to placebo patients. The indicated times are the periods of the highest UV intensity, equating to the ‘brightest’ times of the day when EPP patients are most at risk of developing symptoms. Patients on drug reported a three-fold increase in the median amount of time in direct sunlight compared to placebo. Consequently many patients on drug reported no pain or only mild pain compared to their previous life of experiencing severe phototoxic reactions.

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About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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