Mucocort AB has received approval from the Swedish Medical Products Agency and the Ethics Review Board to commence a clinical trial of an intraoral patch (M045A) for the treatment of aphthous stomatitis, a condition affecting approximately 2 percent of the population and causing frequent mouth ulcers with significant pain for affected patients.
“We are pleased to soon be ready to welcome our first patient to the trial,” says Jean Lycke, project manager for Mucocort AB.

Mucocort’s treatment consists of a self-absorbing patch (M045A), classified under the MDR as a Class II product. Through extensive research and development, this patch has demonstrated the potential for immediate pain relief and promoting healing processes in patients with aphthous stomatitis.

The clinical trial will be conducted in collaboration with Oral Care AB, an established private dental clinic chain also focused on research. Production of the patch is managed by Aurena Laboratories AB, a family-owned company that is also a strategic partner for marketing, sales, and international launch.

Estimated time is six to nine months
Mucocort is pleased that both the clinical trial and future production are taking place in Sweden.
“We look forward to collaborating with Oral Care, and our relationship with Aurena is excellent. Both organizations share our focus on sustainable solutions and improved care. The collaboration with Umeå Biotech Incubator has also been a significant part of our success in developing our patch,” says Jean Lycke.

The estimated duration of the clinical trial is six to nine months. After completion of the study, results will be evaluated to assess treatment effectiveness. The primary endpoint is pain relief, and the study will also include quality-of-life assessments using EQ-5D/OHIP14.

For more information, please contact:
Jean Lycke, Project Manager, Mucocort AB
Phone: +46 702 771 511
Email: jl@emerentiagruppen.com

About Mucocort AB
Mucocort is a company within the medtech sector, focusing on developing innovative medical solutions to improve treatment and quality of life for patients worldwide. Through partnerships with like-minded visionaries, Mucocort AB aims to offer more effective treatments and solutions for various medical needs within mucosal treatment primarily.