Laccure is developing a new product for the treatment and prevention of Bacterial Vaginosis to meet women’s requirements with regard to efficacy, safety and userfriendliness. The new product is based on a proprietary substance that releases lactic acid to establish a physiologic vaginal pH in BV patients.
Bacterial Vaginosis (BV) is caused by an imbalance in the naturally occurring bacterial fl ora of the vaginal mucosa resulting in increased vaginal alkalinity (too high pH), inhibition of the normal lactobacilli growth and discharge with a strong foul fishy odour. It is the most common type of gynaecologic infection and accounts for about half of all vaginal infections. BV has a prevalence of 10-30 % in the developed countries. It often recurs several times per year and many women suffer in silence with these symptoms (international market analyses of 2600 women, data on file). Today‘s treatment consists of antibiotics and shortacting, difficult-to-use pH lowering products.
Laccure’s innovation, product and development to date
Laccure’s innovation is based on a chemical modification of lactic acid resulting in lactic acid release over an extended period of time. The focus is on developing a user-friendly non-smear product which is easy to insert and which can be dosed once a week. The product will be positioned to take advantage of the trend towards non-antibiotic, user-friendly, non-prescription products for bacterial vaginosis.
The product is being developed as a medical device with pharmaceutical quality. The claims will initially relate to pH regulation. The product’s performance, safety and efficacy in patients are currently being documented in a Swedish multicentre trial. Laccure intends to bring the product through all necessary requirements for CElabelling in the EU and then divest the product to an industry partner for further commercialisation.
Laccure AB was founded 2007 and is a project company within the incubator P.U.L.S. AB (www.pulsinvest.se). The large unmet medical need in BV triggered the innovation among Laccure’s founders. The initial development was performed at the Universities of Lund, Sweden, Göteborg, Sweden, and Gdansk, Poland. Further pharmaceutical development and GMP manufacturing for clinical trials as well as preclinical studies have been performed using various contract service providers. The manufacturing of the innovative active substance is performed by PURAC Biomaterials in the Netherlands, one of the largest manufacturers of lactic acid based products. The people behind Laccure are described on www.laccure.com.
Laccure is a P.U.L.S. project company
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