Clinuvel Pharmaceuticals (CUV: $11.32) has completed recruitment for the first of two Phase III studies assessing its drug SCENESSE as a treatment for vitiligo, in combination with standard-of-care narrowband UVB therapy.
More than 200 patients have now been enrolled across 37 sites in the US, France, the UK, and Kenya. Patients in the active treatment arm will receive SCENESSE every three weeks for a total of 20 weeks, along with narrowband UVB therapy twice weekly.
The primary endpoint is the number of patients who achieve at least a 50% reduction in skin discoloration at 140 days. A secondary endpoint will assess treatment response 24 weeks later (308 days in total). A second Phase III study is scheduled to commence following discussions with regulatory authorities.
The first study began in October 2023. Recruitment was initially slow, but accelerated after protocol changes were implemented in August 2023. The most significant change allowed patients in the control group to access SCENESSE after completing the study.
Results from this first pivotal study are expected in the second half of next year. Clinuvel believes the commercial potential for vitiligo is significantly greater than that for erythropoietic protoporphyria (EPP), which is SCENESSE’s currently approved indication.
Clinuvel is capitalised at $567 million and held $198 million in cash at the end of last year.
Bioshares Recommendation: Buy
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