The Clinuvel Pharmaceuticals Limited (ASX: CUV) share price has surged higher today, climbing as much as 24.97%. The increase follows news that Clinuvel has secured a meeting with the US Food and Drug Administration (FDA) to progress the use of its drug, SCENESSE, for the treatment of vitiligo.
Proposed study design
The company today announced that the United States FDA has confirmed a meeting to discuss and agree on a North American development program for SCENESSE for the treatment of pigment loss disorder vitiligo.
Vitiligo is a skin disorder characterised by the appearance of white to off-white skin patches in different parts of the body due to the loss of melanin (pigment) production. Vitiligo often affects the face, chest, and extremities and may gradually spread to the limbs and other body surfaces. The causes of vitiligo are unknown.
SCENESSE is to be used as part of a combination therapy with narrow band UVB (NB-UVB). The FDA meeting will discuss the proposed study protocol design and be attended by global vitiligo experts. Pending ongoing safety and efficacy of its vitiligo program, Clinuvel will seek to file a supplemental New Drug Application for SCENESSE.
SCENESSE was approved by the FDA for use in the treatment of erythropoietic protoporphyria (EPP) last October. A supplemental New Drug Application is required to add a new indication of an approved drug in the USA. The submission will consist of clinical data supporting the new indication and any additional studies which may be required to support the efficacy and safety in the new indication.
Discussions with the FDA will focus on study protocol design, study objectives, and final development leading to market authorisation. In clinical trials conducted by Clinuvel, the combination of SCENESSE and NB-UVB light treatment resulted in more rapid and extensive repigmentation than NB-UVB light treatment alone.
In one proof-of-concept study undertaken in the US, a significant recovery of pigmentation was observed in patients with darker skin tones. In another, a more pronounced clinically meaningful recurrence of pigmentation for total body and areas of the head and neck was observed.
Management commentary
Commenting on today's update, Clinuvel's Chief Scientific Officer Dr Dennis Wright said:
"Our team has been waiting for this moment since we first planned to gain US marketing authorisation for SCENESSE in EPP."
"Our overall aim is to provide repigmentation in patients who are most affected by vitiligo, reduce the clinical visits required by the current NB-UVB standard treatment protocols and thus see a decrease of radiation exposure for these patients," he added.
