Laccure AB has developed a breakthrough product for treatment and prevention of bacterial vaginosis (BV) with a proven cure rate of 80 per cent already after one vaginal tablet. The product recently got CE marking as a Class IIa medical device.
Addressing the unmet needs of the 300 million women suffering from BV infection, the new treatment represents a considerable commercial potential in the OTC market.
Laccure’s novel, non-prescription vaginal tablet has been tested in randomized controlled clinical multicenter studies including 126 women. The results show a cure rate of 80 per cent following a single administration of one vaginal tablet. Along with a good safety profile and by fully meeting women’s need for user-friendly comfort, this represents a major improvement in the treatment of BV. Moreover, the use of this new treatment might significantly reduce the need for antibiotics and consequently limit the risk of antibiotic resistance. The product is based on a proprietary substance that releases lactic acid over an extended period of time to decrease elevated vaginal pH.
“Showing such high cure rates already a week after single administration exceeded our ambitious expectations for this product. The study results have been confirmed in two independent studies which led to the successful CE marking, says Dr Jeanette Robertsson, CEO of Laccure AB.
“As there is a lack of effective and user-friendly treatment that is also effective in preventing recurrent episodes of bacterial vaginosis, this product will truly fill an unmet need in the market. Product launch in early 2013 is entirely possible if we can find the right marketing partner,” says Dr Lennart Bruce, board member of Laccure AB.
Bacterial Vaginosis (BV) is the most common vaginal infection in women of childbearing age. BV is caused by an imbalance in the naturally occurring bacterial flora of the vaginal mucosa resulting in lack of vaginal acidity, discharge with a pronounced foul, fishy odor and inhibition of the normal lactobacilli growth. Many women suffer from frequent recurrences. Today, there is a lack of effective and safe products that are also user-friendly. Women are often embarrassed having BV and quality of life is negatively affected.
Initial product research was carried out at the University of Lund, Sweden, and University of Gdansk, Poland. Further pharmaceutical development and GMP manufacturing for clinical trials as well as preclinical and clinical studies have been performed in collaboration with a number of contract development organisations.
Laccure was founded in 2007 and is a Swedish project company of the life-science incubator P.U.L.S. AB. Initial product research was carried out at the University of Lund, Sweden, and University of Gdansk, Poland.