- Primary endpoint achieved in all three trials demonstrating acceleration of wound healing for Oleogel-S10
- Excellent safety profile for Oleogel-S10 confirmed
Niefern-Öschelbronn, Germany, September 2, 2014 / B3C newswire / - Birken AG, a biopharmaceutical and dermo-cosmetic company, announces positive results from three clinical phase III trials with Oleogel-S10, an ointment based on dry extract from birch bark for patients with partial thickness wounds. The phase III results demonstrate a faster wound healing with Oleogel-S10 compared to current standard of care consisting mainly of applying wound dressing materials. Birken is currently preparing the submission of the marketing authorization application to the European Medicines Agency (EMA). After approval, Oleogel-S10 will be available for marketing and distribution in the European Union (EU) in the first half of 2016.
“Proven treatments to actively speed up the healing process of partial thickness wounds represents still an unmet medical need and Oleogel-S10 aims to become the first pharmaceutical to accelerate the healing of these kinds of wounds. Near-term plans for Birken include seeking out licensing and partnering opportunities with pharmaceutical companies to commercialize Oleogel-S10,” stated Dr. Tobias Zahn, Head of Sales and Business Development at Birken AG.
Partial thickness wounds are painful, open skin wounds of extended area that are able to heal within a few weeks, such as burn wounds. Due to the lost skin barrier these wounds are at risk for infections and wound healing complications.
The three phase III trials, conducted in parallel and enrolling a total of 280 patients in 48 European centers, provide independent confirmation of the individual study results. In the studies, patients’ wounds were divided into two halves enabling a direct intra-individual comparison of differences between Oleogel-S10 and standard of care treatment and avoiding confounding factors such as individual differences in wound depth and individual patient health status. Observer-blinded evaluation based on photographs was used for the assessment of the primary endpoint.
In each of the three clinical phase III trials the primary endpoint was achieved with a statistical significance of p<0.0001 (BBW-11 trial in grade 2a burn wounds and BSH-12 trial in split-thickness skin graft donor site wounds) and p=0.0232 (BSG-12 trial in split-thickness skin graft donor site wounds).
Time is essential in wound therapy. Faster wound healing is associated with a reduced risk of infections and other wound healing complications, improved functional and aesthetic results of the regenerated skin and scar tissue, and in case of extended wound areas with reduced mortality. The phase III results demonstrate faster wound healing of partial thickness wounds with Oleogel-S10 at a new level of medical evidence in this indication.
Oleogel-S10 is an innovative, sterile ointment which consists only of the active pharmaceutical ingredient ‘dry extract from birch bark’ and sunflower oil. In this unique and internationally patent protected formulation the active pharmaceutical ingredient also functions as sole galenic substance. This formulation of only two ingredients minimizes the risk of wound healing irritations caused by additives.
Several pre-clinical and clinical studies have shown that dry extract from birch bark accelerates wound healing and skin regeneration processes. Dry extract from birch bark transiently upregulates pro-inflammatory cytokines (e.g., IL-6) and cyclooxygenase-2 (COX-2) on gene and protein level. Dry extract from birch bark promotes keratinocyte migration, putatively by increasing the formation of actin filopodia, lamellipodia and stress fibers (Ebeling et al., PLoS One, 2014), and promotes keratinocyte terminal differentiation in a TRPC6 calcium channel dependent manner (Woelfle et al., J Invest Dermatol, 2010).
The target indication of Oleogel-S10 is the treatment for accelerated healing of partial thickness wounds, such as
- burn wounds,
- split-thickness skin graft donor site wounds,
- aesthetic treatment wounds (caused e.g. by dermabrasia ablative laser, deep chemical peel),
- radiation wounds,
- skin lesions caused by toxic epidermal necrolysis and
- skin lesions caused by genetic diseases such as epidermolysis bullosa.
Oleogel-S10 aims to become the new standard in the treatment of partial thickness wounds.
Birken AG is a biopharmaceutical and dermo-cosmetic company. The company was founded in the year 2000. Birken’s core business is the extraction of active ingredients from birch bark and the development and sales of medical skin care products as well as pharmaceuticals for acceleration of wound healing.
The development, approval and manufacturing of Oleogel-S10 is subject to extensive oversight by various regulatory agencies. Submission of an application for Oleogel-S10 to EMA or any other regulatory agencies may be delayed of any number of reasons and, once submitted, may be subject to lengthy review and ultimately rejected. Moreover, regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could increase operating costs or delay product launches.
Dr. Mike Bastian
Business Development Manager
Phone: +49 7233 9749-115