Clinuvel Pharmaceuticals (CUV: $15.51) is continuing to expand the applications for its core therapeutic, afamelanotide (Scenesse for the treatment of EPP). In preclinical models it has been shown that afamelanotide can have a positive impact on neurological conditions, including Parkinson's disease.
Afamelanotide binds to MICR. Activating this receptor provides protection from the toxic alpha-synuclein in the brain that destroys neurons and is found to be elevated in patients with Parkinson's disease.
Towards the end of this year, Clinuvel will start the first trial in six patients with Parkinson's disease with afamaelanotide as a potential therapy for this disease.
Endpoints in the study will be whether there is a reduction alpha-synuclein levels, as well as changes in cognition. Patients in the study will receive 11 doses of afamelanotide over two months.
The core program ahead for Clinuvel is the extension of the use of Scenesse for the treatment of vitiligo. However, new indications for the company's growing assets around melanocortins remain important.
Clinuvel is currently conducting Phase III studies with Scenesse for the treatment of vitiligo. The first of its Phase III studies is expected to reach the primary completion point at the end of this year in 200 patients.
Existing Distribution Network
Clinuvel intends to use its existing distribution network in which Scenesse is delivered for EPP for the label expansion to vitiligo. To date 85 clinics have been trained and accredited in the US with a target of 120 centres. Those centres are expected to have a capacity to treat 6,000 new patients a year.
We estimate that currently less than 800 patients are treated globally with Scenesse. While there may be a modest product price drop if Scenesse is approved for the treatment of vitiligo, it represents a potential step change in revenue for the company.
Bioshares recommendation: Buy
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