Wednesday, 15 July 2009 09:00

Clinuvel announces positive results in Phase II Solar Urticaria study

Afamelanotide: a novel photoprotective drug in severe light allergy

Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced positive results from an open-label Phase II study in the severe rare skin disorder Solar Urticaria (SU), conducted at Manchester Hope Hospital UK. In a pilot study of 5 patients, the efficacy of afamelanotide was evaluated as a preventative photoprotectant in this disease.

The objectives of the study were to test the efficacy of subcutaneously administered afamelanotide as a photoprotective drug in patients diagnosed with SU by measuring skin reactions, characteristic ‘wheal’ formation and tolerance to UV and sunlight.

Solar Urticaria

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.

Orphan Designation

Clinuvel obtained orphan designation from the EMEA in June 2009 to develop afamelanotide for the preventative treatment of SU.


In all patients, the tolerance of the skin to light of various wavelengths and intensities was increased following administration of afamelanotide.

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.

Clinuvel’s Chief Scientific Officer Dr Hank Agersborg said:

“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 will now accelerate its program in Solar Urticaria worldwide and apply for permission to start Phase III confirmatory controlled trials.”

“This outcome, together with the recent interim results (January ’09) in our Phase III program in the orphan disease Erythropoietic Protoporphyria (EPP), has made the chances to commercialise our drug realistic and likely.”

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Investor relations contacts:

Australia: Clinuvel Pharmaceuticals Limited, T: +61 3 9660 4900
Europe: Clinuvel AG, T: +41 41 767 45 45
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Clinuvel is an Australian biopharmaceutical company focussed on developing its photoprotective drug, SCENESSE® (afamelanotide) for a range of UV-related skin disorders resulting from exposure of the skin to harmful UV radiation. Pharmaceutical research and development involves long lead times and significant risks. Therefore, while all reasonable efforts have been made by Clinuvel to ensure that there is a reasonable basis for all statements made in this document that relate to prospective events or developments (forward-looking statements), investors should note the following:

  • actual results may and often will differ materially from these forward-looking statements;
  • no assurances can be given by Clinuvel that any stated objectives, outcomes or timeframes in respect of its development programme for SCENESSE® can or will be achieved;
  • no assurances can be given by Clinuvel that, even if its development programme for SCENESSE® is successful, it will obtain regulatory approval for its pharmaceutical products or that such products, if approved for use, will be successful in the market place

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