RIVELIN-CLO SIGNED

Project "RIVELIN-CLO" data sheet

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 Partnership

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 Project objective

Oral lichen planus (OLP) is an immune-related disorder affecting 84M people worldwide (10M in EU and USA). OLP is a chronic condition which can ultimately lead to precancerous lesions, while patients suffering from it may struggle daily with painful and/or burning sensations in the oral mucosa, being thus kept from living their normal lives. Since there is no approved cure for OLP, the primary goals of its treatment are the alleviation of symptoms and the minimization of mucosal damage from erosive lesions. Current therapeutic options involve the use of topical corticosteroids (typically Clobetasol). However, the ways of use available in the market show lack of adherence to the mucosa and there is a high chance that the product is spread to other areas (which results in reduced efficacy and potentially causing undesired topical and systemic side effects). Our Danish company AFYX Therapeutics A/S was founded in 2014 with the aim to develop innovative approaches to treat mucosal diseases such as OLP. We have developed our first product incorporating an innovative technology (using an electrospinning process): the RIVELIN®-CLO patch. It’s the first to have been developed exclusively for the treatment of OLP, and its unique properties include self-adherence to the oral tissues (2h of topical drug application); occlusion of the lesion; lower bystander toxicity (Clobetasol is prevented from being spread by saliva) and the correct dosing every time. Clinical Phase IIb trials of the patch are ongoing with clinics and hospitals across EU and US and through this project we aim to guarantee that RIVELIN®-CLO is a success from a technical, commercial and financial perspectives, before launching it to the international markets. Five years after market launch, we expect to gather 7% of the EU and US combined OLP treatment market share, generating €22.6M revenues to our company and increasing our staff to 40 employees and generate new IP to venture new markets with our technology.