Further Clinical Use of Afamelanotide

Vitiligo affects an estimated 45 million individuals worldwide and is recognised as having a marked impact upon patients’ quality of life and sense of identity.

On 8 March 2021 the US Food and Drug Administration (FDA) hosted, for the first time in its history, a public meeting, Patient-Focused Drug Development for Vitiligo, to better understand the impact of this disorder on patients, and what a meaningful therapy may achieve in terms of the level and rate of repigmentation.

SCENESSE^® has successfully been evaluated in Phase II studies as an adjunct therapy with narrowband UVB (NB-UVB) phototherapy. NB-UVB is not approved for use in vitiligo but is commonly used by dermatologists as the only therapy to which patients, in some degree, may respond.

The Company is engaging with the FDA on the SCENESSE^® vitiligo program, with a discussion planned later in 2021 on the final protocol design for a Phase IIb/III trial. Details of the FDA update was provided in News Communiqué II.

The particular components of CLINUVEL’s vitiligo program were provided in Strategic Update I.