afamelanotide positive Phase III results for erythropoietic protoporphyria

Written by on January 27, 2009 in melanotan with 2 Comments

Clinuvel has  announced positive interim Phase III results from the first of the trialists to complete a 12 month study in Switzerland. The 14 patients in Switzerland will form part of 101 to undergo long term study around the world. Further participants and Europe and Australia are also taking part in the trial.

This is good news for those who might want to try afamelanotide, it is one small step closer to being approved.

Trial participants received subcutaneous doses of 16 mg of afamelanotide or placebo, blinded, alternating every 2 months for a period of 12 months. The dose is delivered via a bioabsorbable implant around the size of a grain of rice, injected under the skin.

The trial’s main measure of success was a reduction in the pain experiences during an episode of phototoxity. The pain associated with EPP is described as intolerable, causing blistering  and swelling.

The second measure of effectiveness of afamelanotide was melanin density which is seen as skin darkening.

Interestingly the 14 patients involved in the trial asked to continue to take the drug for a further 12 months – such was their benefit. This request was granted.

This interim, small trial didn’t show that afamelanotide reduced the number of phototoxic episodes, rather reduced the severity.

Clinuvel Pharmaceuticals announced in mid 2008 that they had been granted orphan-drug status for afamelanotide to treat the skin condition erythropoietic porphyrias. Orphan drug status is granted to new drugs that treat rare conditions and is used as an instrument to obtain accelerated review by the FDA. The FDA allows tax reductions and market exclusivity for orphan drugs to encourage otherwise un-profitable drugs targeting rare conditions to be developed. See a recent post for more information about when afamelanotide will be available.

Clinuvel are “on schedule in our development of afamelanotide and look modestly but confidently ahead to late 2009, when we anticipate the final Phase III results.”

For more details, see the release from Clinuvel to the Australian Stock Exchange.

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

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2 Reader Comments

  1. scott says:

    It is taking already much longer then expected to bring melanotan to the market, hopefully we will see this great medicine on the market soon.

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