MOBERG DERMA RECEIVES APPROVAL TO INITIATE CLINICAL TRIAL FOR LIMTOP
The German- Federal Institute for Drugs and Medical Devices (BfArM) has granted Moberg Derma approval to initiate a clinical phase I trial for Limtop. Limtop is an innovative formulation of an immunomodulatory compound with potential to treat actinic keratosis, genital warts and basal cell carcinoma. The objective is a product with short treatment duration, an improved safety profile and an efficacy similar to or better than that of competing preparations.
”Limtop has the potential to make a real difference for many patients who currently suffer significant side effects, and we are now looking forward to test the formulation clinically. The results from the Phase I study are expected in the second quarter of 2012”, say Peter Wolpert, CEO and founder of Moberg Derma.
Limtop is based on a patent-pending formulation of a proven compound that results in an optimal dose of the active substance being delivered into the skin. The company's preclinical results show that Limtop has a significantly better capacity than existing preparations to transport the active substance to the target tissue in the skin. Actinic keratosis is sun damage to the skin that is characterised by thickening of the horny layer of the epidermis. The condition has become more common as a result of changed lifestyle and increased exposure to strong sunlight. Actinic keratosis can develop into squamous cell carcinoma and should thus be treated. Prevalence varies, as fair-skinned individuals are affected more. In populations in the northern hemisphere the prevalence is reported as being between 11% and 25%. Over a million cases of basal cell carcinoma are reported every year in the USA and the EU.
For further information, please contact:
Peter Wolpert, President and CEO
Telephone: +46 8 522 307 00
Mobile: +46 735 71 35
Magnus Persson, IR
Mobile: +46 73-355 26 01
About Moberg Derma
Moberg Derma AB (publ), based in Stockholm, develops patented topical pharmaceuticals for the treatment of common disorders through the use of innovative drug delivery. The company’s products are based on proven compounds, which reduce time to market, development costs and risk. Moberg Derma’s first product Nalox™/Emtrix® - for nail disorders - became the Nordic market leader directly after launch in autumn 2010 and international launch is ongoing. The portfolio includes approved and launched products to projects in the preclinical and clinical phase. The company began operations at the Karolinska Institute in Stockholm in 2006. The share of Moberg Derma is quoted on the Small Cap list of the NASDAQ OMX Nordic Exchange Stockholm. For further information, please visit: www.mobergderma.se