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Request for FDA Guidance Meeting SCENESSE® in Vitiligo

CLINUVEL requests Type C Guidance meeting to progress the clinical program in vitiligo

CLINUVEL PHARMACEUTICALS LTD today announced it has requested a Type C Guidance meeting with the US Food and Drug Administration (FDA) to seek agreement on the design of a multicentre Phase IIb vitiligo clinical study (CUV104) and the data package necessary to support a supplemental New Drug Application (sNDA) filing for CLINUEL’s drug SCENESSE® (afamelanotide 16mg) in vitiligo.

Vitiligo is a treatment-resistant disease which causes loss of pigmentation and has an intense psychological and social impact on patients, specifically patients of darker skin complexion. There are no pharmaceutical agents approved for vitiligo in the USA. SCENESSE® – which is approved in the USA and Europe for the rare genetic disorder erythropoietic protoporphyria (EPP)1 – has been evaluated as a combination therapy with narrowband ultraviolet B (NB-UVB) light in proof-of-concept clinical trials. Results have shown patients of darker complexion receiving SCENESSE® experienced faster and deeper repigmentation compared to NB-UVB monotherapy.2

FDA GUIDANCE MEETINGS

The FDA encourages at various stages during the development of a new drug product a series of guidance meetings with the Sponsor. In the forthcoming meeting, CLINUVEL will seek FDA agreement on the design of a proposed Phase IIb clinical trial of SCENESSE®. The proposed study, CUV104, is planned to address findings in earlier clinical trials and better understand the effect of NB-UVB combination therapy in repigmenting vitiliginous lesions at specific body sites. The Company will also seek FDA guidance on the requirements for filing a sNDA, which, if authorised, would expand the indications for which SCENESSE® is licensed in the USA.
A response from the FDA on the meeting request is expected within three weeks and, when granted, the meeting is generally held within 75 days of the request.

SCENESSE® – REPIGMENTATION IN PIGMENT LOSS DISORDER VITILIGO

In clinical trials conducted by CLINUVEL (CUV102 and CUV103) the combination of SCENESSE® and NB-UVB treatment resulted in more rapid and more extensive repigmentation than treatment by NB-UVB (current standard of care) alone. In CUV102, a proof-of-concept study undertaken in the US, the more significant recovery of pigmentation was observed in patients with darker skin complexion (Fitzpatrick skin types IV-VI). Afamelanotide has proven to be well tolerated with its safety profile maintained over clinical trials and post-authorisation use. In CUV103, a proof-of-concept study in Singapore, more pronounced clinically meaningful recurrence of pigmentation for total body, head and neck, was observed.

COMMENTARY

“Now that the use of SCENESSE® for photoprotection in EPP has been further validated by the FDA’s approval, we look forward to discussing with the same Division of the Agency a data package which will support the use of SCENESSE® for the treatment of vitiligo,” CLINUVEL’s Chief Scientific Officer, Dr Dennis Wright said.

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