Photocure: Visonac® data published in the British Journal of Dermatology
Phase 2b results demonstrate a significant reduction in inflammatory lesions and a significant improvement in overall acne severity
Oslo, Norway, December 14, 2015: Photocure (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announces the publication of the results from the Phase 2b trial of Visonac (methyl aminolevulinate 80mg/g), a novel topical acne treatment, in the British Journal of Dermatology.
The Phase 2b trial was a multicenter, randomized, double-blind, placebo controlled study in patients with severe acne vulgaris. Results showed Visonac® produced a statistically significant reduction in inflammatory lesions and an overall improvement in acne severity.
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 promising as they demonstrate Visonac's potential as a significant advancement in the treatment of acne patients. There is a high unmet medical need for novel, non-antibiotic 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."
The study included 153 patients enrolled at 15 office-based dermatology practices and hospitals in the US. In patients treated with Visonac, a statistically significant reduction in inflammatory acne lesions of 43.8% was achieved compared to 26.6% in the control group (p=0.003). Visonac also 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. Visonac was well tolerated and no serious adverse events were reported in the study.
Kjetil Hestdal, President and CEO of Photocure, said: "We are pleased to see this data published in such an esteemed journal, and view this as a testament to the potential of Visonac as a new treatment option for the large number of patients globally who suffer from severe acne. Visonac's high level of efficacy coupled with the high patient tolerability demonstrated in the Phase 2b trial are encouraging, and will aid in advancing to the next stage of development."
The full publication of the results from the Visonac phase 2b study, originally completed in 2012, is available through the online publication in The British Journal of Dermatology, "Photodynamic therapy with 80mg/g metyl aminolaevulinate for severe facial acne vulgaris: a randomized vehicle-controlled study" at http://onlinelibrary.wiley.com/doi/10.1111/bjd.14345/epdf
For further information, please contact:
Photocure
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email: kh@photocure.no
CFO Erik Dahl
Tel: +47 450 55 000, Email: ed@photocure.no
About Photocure ASA
Photocure ASA, headquartered in Oslo, Norway, is a specialty pharmaceutical company and world leader in photodynamic technology. Based on our unique proprietary Photocure Technology® platform, Photocure develops and commercializes highly selective and effective solutions in disease areas with high unmet medical need, such as bladder cancer, HPV and precancerous cervical lesions, colorectal cancer and skin conditions. Our aim is to provide solutions that can improve health outcomes for patients worldwide. Photocure is listed on the Oslo Stock Exchange (OSE: PHO). Information about Photocure is available at www.photocure.com.
About Visonac
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.
This information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian Securities Trading Act)