and Clinical Programs

CLINUVEL’s expertise in the role of melanocortins in the function of the human body underpins the Company’s expanded clinical development program. Specific mention of each program is made below:

DNA Repair

  • Deffective DNA skin repair in >2 billion individuals.
  • Initial focus on 1,000 xeroderma pigmentosum (XP) patients.
  • Results CUV151 (n = 9), showed reduced skin damage, statistically decreased UV-erythema dose response, increased minimal erythema dose and skin pigmentation (one dose of SCENESSE® following UV irradiation in disease free individuals).
  • Initial results CUV156 (n = 6), presented to the 32nd Meeting of the Photodermatology Society as part of the 2023 American Academy of Dermatology (AAD) Meeting, showed afamelanotide reduced DNA photodamage.
  • CUV152 (n = 6), ongoing.

Vitiligo

  • Skin depigmentation disorder.
  • Prevalence between 0.1-2% of global population.
  • >250K darker skin type (IV-VI) patients in North America.
  • Positive repigmentation in past studies CUV102 and CUV103.
  • CUV104 (n = 6) underway with focus on SCENESSE® as a monotherapy.
  • CUV105 (n = 150) with combination NB-UVB and SCENESSE® therapy in design.

Arterial Ischaemic Stroke (AIS)

  • 15 million strokes annually, 80% ineligible for treatment.
  • First study (CUV801) results (n=6) showed no safety concerns and improved neurological function.
  • Second study (CUV803) commenced March 2023 (n=12).
  • Initial results of CUV803 showed improvement in three patients administered PRÉNUMBRA® Instant.
  • Study extended in May 2023 from patients with mild and moderate strokes to patients with moderate-to-severe and severe strokes.

Variegate Porphyria (VP)

  • Light exposure causes skin fragility.
  • No existing treatment.
  • 3,000-4,000 patients US/EU.
  • Study CUV040 (n = 6) commenced May 2023.
  • SCENESSE® to reduce severity of phototoxicity
  • and skin disease.

Refer to the feature on “Plans 2024 and Beyond” on page 34 for the timelines to regulatory approval of each of these indications.