2016 Announcements

CLINUVEL completes pre-clinical study of SCENESSE® as combination therapy

02 August 2016

CLINUVEL prepares New Drug Application (NDA) for the treatment of erythropoietic protoporphyria (EPP)

Executive summary:

  • FDA requirement for combination therapy model replicating clinical studies protocol in vitiligo fulfilled
  • Safety of the combination therapy confirms observations in clinical trials CUV102 and CUV103
  • CLINUVEL will request a guidance meeting with the FDA to discuss the upcoming vitiligo trial in North America
  • Safety data add to the New Drug Application package to be submitted to the FDA for erythropoietic protoporphyria (EPP)
  • Global experts agree on the lack of current satisfactory treatment in vitiligo

CLINUVEL Pharmaceuticals [ASX: CUV; Nasdaq International Designation ADR: CLVLY; Xetra-DAX: UR9] today announced that that it has fulfilled the FDA requirement to demonstrate safety in a pre-clinical model prior to progressing further with the clinical development of the combination therapy of its drug SCENESSE® (afamelanotide 16mg) and narrowband UVB (NB-UVB) light in the pigmentation disorder vitiligo.

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