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Epidermolysis bullosa (EB) is a group of rare genetic skin diseases of which Dystrophic EB (DEB) is one of the most severe forms. There are two main types of DEB – the dominant form (DDEB) when the affected person inherits the altered gene from only one parent and the recessive form (RDEB) when the affected person inherits one copy of the altered gene from each parent. RDEB tends to be generally more severe than DDEB. People with DEB have blistering of skin and mucosal membranes that line many tracts and structures of the body, such as the mouth, food pipe etc. Children with DEB are often called ‘Butterfly children’ as their skin is as fragile as the wings of a butterfly. This fragility results from a very weak connection between the dermis (inner layer) and the epidermis (outer layer) of the skin.

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People with DEB live with constant pain and have a high risk of malnutrition and infections. Symptoms include poorly healing wounds, skin infections, fusion of fingers and toes (pseudosyndactyly), anemia, gastrointestinal tract problems and with adulthood some develop very aggressive forms of squamous cell carcinoma (skin cancer). What causes DEB? Currently, there are no approved treatments available that target the underlying cause of DEB. Patients receive treatments that focus on disease management, prevention of complications and prevention of the formation of new blisters. There are palliative treatment options focused on wound care (bandaging, prevention of infection, better wound healing), pain management and itch management. Other points of attention are bone care, nutrition (due to eating difficulties), oral care and eye care.

In addition there is a close surveillance for skin cancer, to which some DEB patients are especially vulnerable. ProQR is developing an investigational drug called QR-313 for people that have DEB due to a mutation in a specific part of the COL7A1 gene called exon 73. We estimate there are approximately 2,000 patients in the Western world that have DEB due to a mutation in this specific part of the gene. QR-313 is designed to exclude exon 73 from the COL7A1 RNA. This approach is also known as exon skipping. Edirol super quartet torrent 1. RNA is the 'blueprint' for protein synthesis. Skipping of exon 73 in the 'blueprint' is expected to lead to a shortened but functional C7 protein.

By restoring the functionality of C7 protein QR-313 aims to bring back the anchoring fibrils and strengthen the skin. This should result in better wound healing and prevent blistering.

QR-313 is a water based gel (hydrogel) that will be applied directly onto DEB wounds (topical administration). QR-313 has received orphan drug designation from the U.S.

Food and Drug Administration and European Medicines Agency. Beyond QR-313 we are working on multiple other programs targeting other mutations causing DEB. Clinical trials In 2018 we started WINGS, our first clinical trial of QR-313. Up to 8 patients (6 years and older) that have RDEB due to mutation(s) in exon 73 of the COL7A1 gene will participate in this phase 1/2 trial. The WINGS study is planned to be conducted at specialized centers in the US and selected European countries. We expect the first interim results from this study to be available during 2018. This phase 1/2 clinical trial is necessary to evaluate the safety and tolerability of QR-313.

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Patient benefit will be assessed as well. QR-313 is an experimental medicine that we are developing for people with dystrophic epidermolysis bullosa (DEB) due to mutations in a specific part of the COL7A1 gene called exon 73. QR-313 is a water based gel (hydrogel) that will be applied directly onto DEB wounds (topical administration).

We have moved the program through the early stages of the development and started the first clinical trial of QR-313 called WINGS. For more information about the program please visit this page or the page about the where we will post regular updates. If you have any other questions please read the FAQ below or contact us through the contact form and we will be happy to answer any question you have.

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