Tromsø, Norway, 29 January 2019 – Biotec Pharmacon’s (OSE: Biotec) has announced that its subsidiary, Biotec BetaGlucans, has finalised treatment in a UK Post Market Clinical Follow-up (PMCF) study on its wound care gel, Woulgan®, in diabetic foot ulcer patients.
Biotec BetaGlucans filed an application to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in June 2018 to finalise the study. The application was accepted in November 2018 and all patients have now been treated.
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 finalised 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 favourable decision to allow the completion of the PMCF study.
The Contract Research Organisation handling the study is now collecting and evaluating the data from the four clinical investigation sites. The results are expected in late Q2 2019.
Christian Jørgensen, CEO, said:
“The acceptance from the MHRA and study completion is a positive step forwards for the Company. These results expected mid-year will provide further validation of our Woulgan® gel product in wound care management.”