Oslo, Norway, May 31, 2012: Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announced today the results of the phase 2b study in acne with Visonac (methyl aminolevulinate 80mg/g), a novel topical acne treatment. In this study, Visonac showed a statistically significant reduction in inflammatory lesions and overall improvement in acne severity.
The phase 2b trial was a multicenter randomized, double-blind, placebo controlled study in patients with severe acne vulgaris. The study included 153 patients enrolled at 15 office based dermatology practices and hospitals in the US. Patients were randomized to receive Visonac topically followed by red light illumination or vehicle cream followed by red light illumination (Control). The treatment regimen consisted of four treatments which were each administered two weeks apart. Efficacy and safety were assessed six weeks after the last treatment. The primary efficacy end-point in the study, reduction of inflammatory acne lesions, was achieved.
In patients treated with Visonac, a statistically significant reduction in inflammatory acne lesions of 43.8% was achieved as compared to 26.6% in the control group (p=0.003). Secondary efficacy end-points in the study included assessment of global acne severity, as measured by a standardized Investigator’s Global Assessment score (IGA). Visonac demonstrated improvement in overall acne severity in a significant percentage of patients as compared to control, 44.0% versus 26.4% (p=0.013), respectively. A significant and comparable reduction in non-inflammatory lesions was achieved in both groups.
Visonac was well tolerated and no serious adverse events were reported in the study. Among patients that received Visonac, a higher number experienced local transient pain during illumination. Additionally, post treatment erythema was reported more frequently in the Visonac arm (89% versus 70%), which most commonly subsided by the following day. Twelve patients withdrew from the study due to adverse events.
Dr David Pariser, Professor of Dermatology, Eastern Virginia Medical School, former president of the American Academy of Dermatology and principal investigator, commented: ”These data are encouraging as they demonstrate that Visonac has the potential to be a significant advance for acne patients. There is high medical need for novel alternative treatment options in this patient population in whom the presence of multiple inflammatory lesions takes a high toll on both their emotional and social well-being.”
Kjetil Hestdal, President and CEO of Photocure, said: “These positive results are a significant milestone as we continue the clinical evaluation of Visonac as a promising new treatment option for the large number of patients globally who suffer from acne. These results lay the foundation for a global registration program which we expect to start in 2013.”
Acne is the single most common skin disease worldwide, and affects up to 85% of all 12-24 year olds. There is a high unmet medical need for patients with acne, where the current mainstay of treatment is oral antibiotics and/or retinoids. Visonac is being developed as the first photodynamic therapeutic option for this large patient population, which can easily and conveniently be administered in dermatology offices. By avoiding the risks of increased antibiotic resistance from long term exposure, and providing a highly tolerable alternative to isotretinoin, Visonac has the potential to satisfy a high unmet medical need. Clinical proof of concept has previously been demonstrated with an excellent safety profile and minimal patient down time.
Visonac® cream is applied to the acne area, and after a short incubation time, the skin is illuminated with red light. The mechanism of action is two fold: an antibacterial effect against P. Acnes and a reduction of sebum production by the sebaceous glands.
For further information, please contact:
President & CEO Kjetil Hestdal
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