Clinuvel Pharmaceuticals Shares Impressive Results For Vitiligo CUV103 Phase II Study

Clinuvel Pharmaceuticals Ltd (ASX:CUV) is a leading biomedical company focusing its R&D on the treatment of phototoxicity and skin related ailments in adults. Its product offerings are in diverse areas that include photomedicine, pharmacology, photocare, pharmaceuticals, and dermatology. The company rides high on its flagship product SCENESSE, its in-built drug as a photoprotective to treat UV related skin disorders.

As per an ASX announcement today, Clinuvel Pharmaceuticals shared impressive results of the CUV103 Phase II medical experimental study conducted at the National Skin Centre in Singapore. The trial evaluated the use of SCENESSE in vitiligo patients of Asian ethnicity with darker skin complexion.

Study Design

A total of 18 Asian patients were successfully enrolled (considering 3 withdrawals) in the CUV103 trial who had 10% or more body surface area affected by vitiligo, a skin disorder showing loss of pigmentation. The pre-requisite for the study was that the people had not received NB-UVB treatment in the six weeks prior to study start.

The respondents were planned to receive total body irradiation with narrowband ultraviolet B therapy (NB-UVB) twice per week for a duration of seven months combined with SCENESSE every 28 days for six months (six doses in total). Evidence from previous studies depicts the impact of combination therapy to induce faster and deeper repigmentation in patients compared to NB-UVB alone.

The scientific hypothesis was designed to test whether a month of dual therapy would result in effective follicular repigmentation via induction of dermal stem cells. Also, it planned to evaluate if this would lead to repigmentation as assessed over time (seven timepoints) in comparison to baseline values.

Study Results

The results proved that the combined treatment was clinically effective in achieving depigmentation in patients with vitiligo. No health hazards or side effects were reported in the study.

The Vitiligo Area Scoring Index (VASI), was used to assess the success of the treatment. VASI is a uniform authenticated scoring structure for measuring the treatment results. The efficacy evaluations showed statistically significant improvement from the beginning of the study till 196 days of treatment comprising of six doses of afamelanotide and seven months of NB-UVB.

A decrease in VASI scores was observed for the total body surface (p<0.001), head and neck (p<0.05) and hands, upper extremities, trunk and lower extremities (all p<0.005)

The evaluations showed statistically significant decreases in the VASI scores compared to baseline (Day 0) and at subsequent timepoints throughout the study.

There were no statistically noteworthy changes in VASI, between the end of the treatment (Day 196) and the follow-up visit (Day 280) (all p>0.05). This suggests that repigmentation had remained stable for the three months following completion of the treatment.

However, for the first time the cultural aspects of skin darkening were observed during the CUV103 trial. The overall darkening of the skin was undesirable and unacceptable in Asian origin patients.

Financial performance

As per recently shared company financials, the company enjoyed significant growth in revenues over past three years due to an increase in demand of SCENESSE across Europe and Switzerland. The annualized growth rates of 59%, 87% and 79% are reported for last three years.

Stock performance

CUV’ stock has shown impressive performance this year with a YTD return of 126.62% till date. However, over a month share price has increased marginally at 1.59%. The current share price is $18 with the close of trading hours today.

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