Table 4.

Summary of clinical trials of afamelanotide

Year	Authors	Study location	Study design	Study duration	#Subjects	Drug exposure	Afamelanotide dosage	Findings
2007	Clinuvel CUV010; Harms et al (2009)43,49	Switzerland	Pilot phase II	4 months	5	Two doses afamelanotide, 60-day interval	20 mg implant	Increased tolerance to photoprovocation, p=0.007; increased melanin density, p=0.004
2010	Clinuvel CUV01745	Australia/Europe	Phase III randomized double blind placebo- controlled trial	12 months	91	Three doses afamelanotide, three doses placebo, alternating implants, 60-day interval	16 mg implant	Reduction in days on which patients experienced cutaneous pain, p=0.0023; increased sun exposure, p<0.0001; reduced average pain severity, p=0.0017
2011	Clinuvel CUV029; Langendonk et al (2015)34,51	Europe	Phase III randomized double blind placebo- controlled trial	9 months	74	Afamelanotide or placebo, 60-day interval, five total implants	16 mg implant	Increased duration of pain-free time in direct sunlight, p=0.005; reduction in phototoxic reactions, p=0.04; increased sun tolerance, p=0.005; improved quality of life, p=0.005 at day 120
2011	Clinuvel CUV03056	United States	Phase II randomized double blind placebo- controlled trial	6 months	77	Afamelanotide or placebo	16 mg implant	Increased sun tolerance from 10am to 3pm, p=0.036; improved quality of life, p<0.001 at day 180
2013	Clinuvel CUV039; Langendok al34,52	United States	Phase III randomized double blind placebo- controlled trial	6 months	94	Three doses afamelanotide or three doses placebo, 60-day interval	16 mg implant	Increased duration of pain-free time in direct sunlight, p=0.04; improved quality of life, p=0.02 at day 180
2015	Biolcati et al53	Italy, Switzerland	Retrospective analysis	8 years	115	1,023 implants over 8 years; varies by study center	16 mg implant	Improved quality of life scores; high compliance/low discontinuation rates; good safety profile

Note: Selected key features of the clinical trials of afamelanotide from 2007 to 2015 are summarized.