Slide 1: Clinical Study Results - US Phase IIa Vitiligo Study CUV102
For personal use only Clinical Study Results - US Phase IIa Vitiligo Study CUV102 Video reference: www.youtube.com/watch?v=4qwCVHBnxR4 December 19 2012 ASX: CUV XETRA-DAX: UR9 ADR: CLVLY http://www.clinuvel.com/en/vitiligo
Slide 2: Vitiligo: acquired depigmentation disorder
I have been living a single life in two colours. It is not easy to accept a total change of For personal use only your skin. ‐ Indian vitiligo patient It’s “emotional warfare”, the battle you wage in your mind. ‐ US vitiligo patient • Acquired depigmentation disorder • Progressive spread of ‘lesions
Slide 3: Vitiligo causes and triggers
For personal use only • Believed to be an ‘auto-immune’ disease with a genetic component • Immune system destroys melanocytes in skin • Triggered by environmental factors – Stress – Skin damage – photodamage, cuts, burns etc – Chemicals
Slide 4: Current vitiligo therapies
For personal use only • No totally effective therapy identified to date • Treatment is aimed at: 1. Halting depigmentation and stimulating repigmentation 2. Achieving a lasting result • Current recognised therapies: – Camouflage – Narrowband UVB, PUVA, broadband light therapies – Transplant surgery
Slide 5: Healthy skin versus vitiliginous skin cross section
For personal use only A cross section showing healthy A cross section showing vitiliginous skin with melanocytes skin lacking melanocytes but with stem cells present in the niche.
Slide 6: Study design and objectives
For personal use only • Proof-of-concept Phase IIa • Three US sites: Detroit, Los Angeles, New York • Group A: afamelanotide + NB-UVB • Group B: NB-UVB monotherapy • Primary objective: – To compare the efficacy of afamelanotide implants and NB-UVB light in the treatment of vitiligo. • Secondary obje
Slide 7: Study treatment and follow-up schedule
For personal use only 6 month treatment period 6 month follow up period Group A 1 month 4 months 1 month Afamelanotide + NB‐UVB combination NB‐UVB NB‐UVB monotherapy therapy monotherapy Adult vitiligo 6 months standard clinical care patients Group B NB‐UVB 6 months NB‐UVB monotherapy monotherapy Day
Slide 8: Study results: repigmentation outcomes
For personal use only • N=41 • The extent of repigmentation in the SCENESSE®/NB-UVB group was significantly greater than observed in the NB-UVB-alone group (VASI, p=0.025 ; VETF p=0.023; 95% CI) • Significantly better, more complete and deeper repigmentation in active patients with darkest skin comp
Slide 9: New York site, Group A (active)
New York site, Group A (active) For personal use only Day 0 Day 27 Day 55 Day 111 Day 176 Baseline After 9 NBUVB After 15 NBUVB After 27 NBUVB After 40 NBUVB treatments treatments, 1 implant treatments, 3 implants treatments, 4 implants
Slide 10: New York site, Group A: follicular repigmentation
New York site, Group A (active) Enlarged image of left upper leg showing follicular repigmentation For personal use only Day 0 Day 55 Day 176 Baseline After 15 NBUVB After 40 NBUVB treatments, 1 implant treatments, 4 implants
Slide 11: Detroit site, Group A (active)
Detroit site, Group A (active) For personal use only Day 0 Day 195 Baseline After 59 NBUVB treatments, 4 implants
Slide 12: Los Angeles site, Group A (active)
Los Angeles site, Group A (active) For personal use only Day 0 (Baseline) Day 35 (15 treatments/1 implant) Day 66 (29 treatments/2 implants) Day 171 (62 treatments/4 implants)