Birken Announces Positive Results of Phase III Trials with Oleogel-S10
News Sep 03, 2014
Birken AG has announced 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.