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FDA Type C Meeting for SCENESSE® in Vitiligo

EXECUTIVE SUMMARY

  • CLINUVEL, FDA and global vitiligo experts attended FDA meeting on 29 April
  • Type C Meeting followed up with further amendments to CUV104 clinical study protocol

CLINUVEL PHARMACEUTICALS LTD today confirmed that it attended a Type C meeting on 29 April with the US Food and Drug Administration (FDA) and global clinical experts in vitiligo to discuss the North American development program for SCENESSE® (afamelanotide 16mg) for the treatment of vitiligo (generalised loss of pigmentation).1
Following this meeting the FDA, clinical experts and CLINUVEL will finalise the documentation and clinical trial protocol (CUV104) to advance SCENESSE® as the first systemic repigmentation agent in North America.

FDA REGULATORY PROCESS
Pending ongoing safety and efficacy in its vitiligo program, CLINUVEL seeks to file a supplemental New Drug Application (sNDA) for SCENESSE®. A sNDA, referred to as an “efficacy supplement”, is required to add a new indication to the labelling of an approved drug in the USA, with the submission consisting 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. SCENESSE® was approved by the FDA in October 2019 to increase pain-free light exposure in adult patients with the rare metabolic disorder erythropoietic protoporphyria (EPP).

SCENESSE® – REPIGMENTATION IN VITILIGO (PIGMENT LOSS)
In clinical trials conducted by CLINUVEL (CUV102 and CUV103) the combination of SCENESSE® and narrowband ultraviolet B (NB-UVB) treatment resulted in more rapid and extensive repigmentation compared to treatment with

Follicular repigmentation observed on left upper leg in a patient during CUV102 study. From left to right: baseline; day 55 after 15 NB-UVB treatments and one SCENESSE® implant; Day 111 after 27 NB-UVB treatments and three SCENESSE® implants; Day 176 after 40 NB-UVB treatments and four SCENESSE® implants. Images reproduced courtesy of the treating physician and patient.

NB-UVB alone.2 In CUV102, a proof-of-concept study undertaken in the US, a significant recovery of pigmentation was observed in patients with darker skin complexions (Fitzpatrick skin types IV-VI). In CUV103, a proof-of-concept study in Singapore, a more pronounced clinically meaningful repigmentation was observed for total body and areas of the head and neck. However, it was found that Singaporean vitiligo patients were not always accepting of the transient darker pigmentation of the confluent skin following afamelanotide treatment.
Afamelanotide has proven to be well tolerated to date with its safety profile maintained over clinical trials and post-authorisation use.

COMMENTARY
“The meeting was held in good spirits and the discussion centred around identifying the highest unmet medical need, the role of NB-UVB in clinical practice, and the use of afamelanotide as a systemic repigmentation agent,” CLINUVEL’s Chief Scientific Officer, Dr Dennis Wright said.
“Most pleasing was that the senior managers and decision makers within the FDA’s Division of Dermatology and Dental Products were actively engaged in the discussion, and they were the same professionals who had reviewed and approved SCENESSE® for EPP in October 2019, thus the knowledge on SCENESSE® was current.
“It is our goal for CLINUVEL to be the first company to launch a pharmaceutical product which addresses the unmet needs of the most severely affected vitiligo patients.”

ABOUT VITILIGO
Vitiligo is a skin disorder characterised by the appearance of white to off-white skin patches (depigmented lesions) in different parts of the body due to the loss of melanin (pigment) production by melanocytes, the skin cells responsible for skin pigmentation. In vitiligo, melanocytes appear to lose their function. Vitiligo can start at any anatomical site and at any age and its causes are unknown (idiopathic). It is hypothesised that both genetic and environmental factors contribute to cause an autoimmune response in this condition.
Vitiligo often affects the face, chest and extremities and may gradually spread to the limbs and other body surfaces. Patients are most affected psychologically when exposed parts of the body show extensive loss of pigmentation. Although vitiligo is seen in all skin types (Fitzpatrick types I-VI), the highest psychological and societal impact is reported in darker skin complexions.

1 SCENESSE® (afamelanotide 16mg) is approved in the European Union as an orphan medicinal product for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). SCENESSE® is approved in the USA to increase pain free light exposure in adult EPP patients with a history of phototoxicity. Information on the product can be found on CLINUVEL’s website at www.clinuvel.com. 2 CLINUVEL has published a series of scientific communiques on program for vitiligo and the mechanism of action of SCENESSE®: Vitiligo Communique I, Vitiligo Communique II, Vitiligo Communique III. Results from clinical trials of SCENESSE® and NB-UVB have been published in:  
  • Lim, H. W. et al. (2015). Afamelanotide and Narrowband UV-B Phototherapy for the Treatment of Vitiligo: A Randomized Multicenter Trial. JAMA Dermatology. 151(1), 42.
  • Toh, J. J. H. et al. (2020). Afamelanotide Implants and Narrow-band Ultraviolet B Phototherapy for the Treatment of Nonsegmental Vitiligo in Asians. JAAD. ePub 24 January 2020.