Bioinicia presents its state-of-the-art project with Dermtreat A/S, a Danish biopharmaceutical company focused on developing innovative approaches for the treatment of mucosal diseases. Dermtreat’s lead product is the Rivelin® patch, which in its first application is being targeted towards the treatment of Oral Lichen Planus: a chronic condition that affects 1-2% of the population. The Rivelin® patch will provide a novel treatment option for the localized delivery of medicinal drugs to damaged or diseased mucosal tissue.
This product has been developed by Dermtreat with support from scientists from the University of Sheffield’s School of Clinical Dentistry, and Bioinicia, and is being manufactured by Bioinicia: specialists in the electrospinning process who provide contract development and manufacturing; and GMP-certified manufacturing of electrospun materials. Rivelin® is a mucoadhesive patch, consisting of two layers of electrospun nanofibres, which can be placed directly onto the wound site to provide targeted, unidirectional delivery of an active pharmaceutical drug to where it is needed. This improves upon existing off-label treatment methods such as creams, mouthwashes or ointments, which are unable to effectively restrict the delivery of drug to only the diseased tissue, and therefore require higher dosage and can result in adverse side effects to surrounding healthy tissue.
The Rivelin® patch provides a novel drug delivery platform that could also be applied for the treatment of other oral conditions and mucosal diseases. By incorporating a drug in an occlusive and bioadhesive patch, the drug will be targeted to the intended area, providing an extended duration of drug delivery; less bystander toxicity; correct dosing every time; and occlusion of the lesion, providing pain relief and protecting against infections.
Together, with an easy and convenient application, this should ensure improved patient compliance, further contributing to a higher efficacy rate.
Professor Jens Hansen, President of Dermtreat A/S and inventor of the Rivelin® patch said: “The patch is made using electrospinning technology. Here, the drug—in this instance, clobetasol—is incorporated into very fine polymer fibres that form a mesh-like lattice as the patch is made. This creates a patch with a very large surface area, which, along with specially selected adhesive polymers, allows the patch to adhere to the moist surfaces of the oral cavity. It’s a bit like the hairs on the feet of a gecko—they provide a large surface area so that they can stick to walls and then climb them. Once adhered, the moisture on the oral mucosal surface interacts with the polymers, causing the release of the steroid or drug directly into the diseased tissue. Because the patch has a backing layer, the steroid release is unidirectional—into the tissue only—and limited drug is released into the oral cavity.”
Dermtreat A/S has recently been awarded $17.7 million from Sofinnova Ventures, Novo A/S and Lundbeckfonden. The funding has taken the patches into phase two clinical trials, which run at several sites in both the US and Europe. This phase enrols approximately 240 adult patients diagnosed with OLP and with at least one visible and measurable ulcerative lesion. Patients are treated twice daily for 28 days to demonstrate the efficacy and safety of different doses of Rivelin® patches.
The complete research has been published in the journal Biomaterials.
About Bioinicia
Bioinicia S.L. is a privately held materials science and engineering company dedicated to the development, industrial scale-up and manufacturing of nano- and microstructured materials by electro-hydro dynamic processes (i.e. electrospinning and electrospraying) on behalf of their clients, and to providing premium quality equipment for laboratory to industrial-scale processing.
Bioinicia acts as a partner for product development, electrospinning-electrospraying technology and industrial manufacturing.
For additional information, please visit www.bioinicia.com.
About Dermtreat
Dermtreat A/S is a private, Danish biopharmaceutical company.
Shareholders include Sofinnova Ventures, Novo A/S, Lundbeckfonden and Welfare Tech Invest.
For additional information, please visit www.dermtreat.com.