Tromsø, Norway—Biotec Pharmacon announced today that its subsidiary Biotec BetaGlucans has been awarded up to NOK 8 million in a grant by the Research Council of Norway for a project titled “Bioactive wound healing dressing with beta-glucan for treatment of hard-to-heal wounds.” The project is to be supported over 4 years, although the award is subject to successful contract negotiations between the parties.
“We are pleased to have been awarded this grant, which serves as a great testament to the hard work being done at Biotec BetaGlucans. It will help us develop a broader set of treatments for the many people suffering from different types of hard-to-heal wounds,” said Christian Jørgensen, CEO.
The grant has been awarded from the User-driven Research-based Innovation Program (BIA), and the focus of the project will be to develop novel bioactive gel-forming fibre dressings. These dressings will contain soluble beta-glucan (SBG) for the treatment of hard-to-heal wounds by re-activating the healing process.
The project aims to develop new and cost-effective wound healing devices for the treatment of large hard-to-heal wounds, exuding wounds (burns and ulcers), donor-site wounds and wounds on mucosal surfaces.
Biotec Pharmacon also announced in late January that its subsidiary, Biotec BetaGlucans, has finalized treatment in a UK Post Market Clinical Follow-up (PMCF) study on its wound care gel, Woulgan, in diabetic foot ulcer patients.
According to Biotec’s website, “Woulgan Bioactive Beta-Glucan Gel is an active wound healing product containing soluble beta-glucan. The product provides an optimal moist wound-healing environment, re-hydrates necrotic tissue and aids in autolytic debridement. The active ingredient in Woulgan is soluble beta-glucan, a proprietary substance shown to promote angiogenesis, cell proliferation and wound contraction.”
Biotec BetaGlucans filed an application to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in June 2018 to finalize the study. The application was accepted in November 2018, and all patients have now been treated.
“The acceptance from the MHRA and study completion is a positive step forwards for the Company,” noted Jørgensen. These results expected mid-year will provide further validation of our Woulgan gel product in wound care management.”
The study, initiated in 2015, was part of the MHRA’s requirements to assess the safety and usefulness of Woulgan before approval as a medical device in the management of wounds. The study aimed to recruit 60 patients for treatment with Woulgan gel and 20 with a commercial hydrogel from Smith & Nephew (Intrasite). The study was allowed to be finalized after having recruited just above 60 patients in total.
In parallel with this study, Biotec Pharmacon ran a large 300-patient clinical study in the UK (including diabetic patients), demonstrating the Woulgan gel’s excellent safety profile and its clinical efficacy and usability. This evidence, alongside case studies, has contributed to the MHRA’s favorable decision to allow the completion of the PMCF study.
The contract research organization handling the study is now collecting and evaluating the data from the four clinical investigation sites. The results are expected in late Q2 2019.