Event – Clinuvel needs positive Scenesse data to spark recovery

Clinuvel Pharmaceuticals is on the verge of announcing crucial clinical data on its lead pipeline candidate, Scenesse (afamelanotide), being developed for a range of light and UV related skin disorders.

Positive results would go a long way to improving the drug’s chances of gaining European approval next year and breathe much needed life into the Australian company’s shares which have lost a third of their value in the last 12 months to trade at A$1.53, close to an eight-year low. Having spent $115m (A$80m) so far on developing Scenesse – more than double Clinuvel’s current market value of $50m - and with just $19m left in cash to support further clinical, regulatory and eventually commercial commitments, Scenesse needs to deliver.

Photoprotection

Clinuvel is testing Scenesse in a range of so-called photodermatoses, including erythropoietic protoporphyria (EPP), nonsegmental vitiligo (NSV), polymorphous light eruption (PLE) and solar urticaria (SU).

Scenesse could provide prophylactic treatment to patients suffering from these disorders by stimulating melanin which is known to have photoprotective properties. Specifically, afamelanotide is an analogue of alpha-melanocyte stimulating hormone (a-MSH), which activates eumelanin in the skin.

The product is injected underneath the skin as a dissolvable implant about the size of a grain of rice. Skin pigmentation is activated immediately and the photoprotective effect lasts up to two months.

So far Scenesse has reached late-stage clinical trials in EPP, a severe form of phototoxicity resulting in intolerable pain, swelling and scarring, usually of the exposed areas such as the face, hands and feet. EPP affects approximately 10,000 people globally, an estimated 4,000 in the US.

Crucial data

Data from two completed trials in EPP – a US phase II study (CUV030) and a confirmatory European phase III trial (CUV029) – are due to be announced within weeks.

Both trials are double-blind, randomised, placebo-controlled studies, covering 100 patients in the US trial and 70 in the European trial. The primary endpoint in both studies is the severity of phototoxic reaction, measured by a visual analogue scale. Secondary outcomes include the number of phototoxic reactions, quality of life questionnaire results and treatment emergent adverse events.

Key clinical results so far, from a phase II (CUV010) and a phase III (CUV017) in Europe - have shown that Scenesse significantly reduces the severity and number of phototoxic reactions in EPP, while being well tolerated.

Expansion

Positive results from these trials will support an impending application in Europe. In May the company received confirmation from the EMA that Clinuvel’s proposed submission would meet all its filing requirements. Clinuvel intends to submit its dossier in the fourth quarter for EPP.

The data would also provide impetus to recruitment in a phase II trial of Scenesse in NSV, a much larger indication which is estimated to affect three million people in the US and Europe. Vitiligo is a common skin disorder in which the pigment producing cells of the skin (melanocytes) are absent or lack activity, causing lighter de-pigmented patches of skin to appear.

The FDA approved the NSV trial in March and recruitment is expected to start next month.

Nomura, who have a ‘buy’ recommendation on Clinuvel shares with a price target of A$4.50, estimate an initial selling price of Scenesse at €1,500 per implant, but which will decline 2% per year. The bank’s current price target only reflects the drug’s potential in EPP, but analysts have also estimated the NSV opportunity to be worth A$10 a share; they estimate the market to be worth $1.2bn.

While Clinuvel has some way to go if it is to come anywhere close to these lofty valuations – and Nomura analysts expect at least a A$20m equity issue within the next 12 months – positive trial results would be an encouraging start.

Confirmatory PIII EU trial CUV029 NCT00979745
Confirmatory PII USA trial CUV030 NCT01097044

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