New Preclinical Data for Calcipotriol/betamethasone dipropionate (0,005%/0,05%) Foam Presented at American Academy of Dermatology Congress

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LEO Pharma A/S

07 Mar, 2016, 08:00 GMT

BALLERUP, Denmark, March 7, 2016 /PRNewswire/ --

Data presented in a Late Breaking Science session at the 74th Annual Meeting of the American Academy of Dermatology (AAD) in Washington, D.C. demonstrate that calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g) foam formulation is a stable supersaturated solution of the active ingredients, compared to calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g ointment in which the active ingredients are suspended.[1] The data presented at AAD showed that no calcipotriol or betamethasone dipropionate crystals were identified in the foam spray following application and for up to 18 hours. However, crystals were present immediately upon application of the ointment formulation. These data may provide a potential explanation for the improved clinical efficacy observed in clinical trials.

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"We are extremely pleased with the results of this preclinical study, which continue to build our base of evidence to support the efficacy for our product and illustrate why this treatment can make a difference to people living with psoriasis vulgaris," said Gitte Aabo, President and CEO of LEO Pharma. "The data presented at AAD highlight the supersaturation of the product and provide further of evidence of how the product can help patients living with psoriasis vulgaris."

The calcipotriol/betamethasone dipropionate foam has shown increased skin penetration[2] and improved clinical efficacy[3],[4] compared to the calcipotriol/betamethasone dipropionate ointment. In a Phase II head-to-head clinical trial conducted in 376 subjects with plaque psoriasis, 54.6% of patients using once-daily calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g) foam achieved treatment success as determined by Investigator's Global Assessment at Week 4 compared to 43% of patients using the calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g ointment treatment (p=0.025).[4]

"Supersaturation is important for a topical treatment from a dermatological perspective, as it has been shown to improve how effectively a medicine can penetrate the skin," said Dr. Richard Warren, Senior Lecturer and study author. "The results of this study provide a potential explanation that, at least in part, may help us understand why the foam formulation of calcipotriol and betamethasone dipropionate was more effective than the ointment in skin penetration and clinical efficacy."

About Psoriasis  

Psoriasis is a chronic, inflammatory skin disease, which is frequently accompanied by multiple physical and/or psychological comorbidities, such as metabolic syndrome and psoriatic arthritis.[5]

Psoriasis is estimated to affect about 2-4% of the population in western countries.[6] 80% of patients are affected by psoriasis vulgaris - the most common type of psoriasis.[7]

Topical treatments are first-line therapies for the majority of patients suffering from psoriasis.[7]

About LEO Pharma A/S 

LEO Pharma helps people achieve health skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions.

Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions.

LEO Pharma is headquartered in Denmark and employs around 5,000 people worldwide.

For more information about LEO Pharma, visit http://www.leo-pharma.com
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References 

  1. Warren R, et al. Supersaturation of calcipotriene and betamethasone dipropionate - facilitating the improved clinical efficacy of the fixed combination spray foam LEO90100 (calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD)) as compared to other formulations of Cal/BD (abstract)
  2. Hollesen Basse L; ESDR 2014; Copenhagen, Denmark; Poster 192
  3. Leonardi et al; J Drugs Derm 2015;14;12; 1468-82
  4. Koo et all; Superior Efficacy of calciotriene and betamethasone dipropionate aerosol foam versus ointment in patients with psoriasis vulagaris - a randomized phase II study. J Dermatol Treat 2016; 2; 120-127
  5. Taraska V, et al. Fixed combination aerosol foam calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD) exhibits no impact on the HPA axis and calcium homeostasis in patients with extensive psoriasis vulgaris: a multicenter, single-arm, Phase II, 4-week MUSE study. Presented at the Skin Disease Education Foundation's 15th Annual Las Vegas Dermatology Seminar & the 11th Annual SDEF Psoriasis Forum, October 30-November 1, 2014
  6. Parisi R, et al. Global Epidemiology of Psoriasis: A Systematic Review of Incidence and Prevalence. The Society for Investigative Dermatology. J Invest Dermatol 2013;133(2):377-85
  7. Reich K, et al. Efficacy of a fixed combination of with calcipotriol/betamethasone dipropionate topical gel in adult patients with mild to moderate psoriasis: blinded interim analysis of a phase IV, multicentre, randomized, controlled, prospective study. Journal of European Academy of Dermatology Venereology 2014: October (epub ahead of print) DOI: 10.1111/jdv.12774

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