Pharmaceutical Business review

Osel initiates two phase II Lactin-V trials

Lactin-V, a capsule containing a natural human bacterial organism, will be studied in a total of eight centers for recurrent urinary tract infection (RUTI) and recurrent bacterial vaginosis (RBV).

Both diseases result from deficiencies in the normal lactobacillus-dominated microflora within the reproductive and urinary tracts of susceptible women. Lactin-V has been optimally formulated to restore the protective microflora to combat infections and is expected to meet an unmet medical need.

Urinary tract infections (UTI) account for almost 11 million physician visits each year in the US, and an equal number in Europe. While a routine UTI is easily treated with a short course of oral antibiotics, treatment of RUTI with multiple courses of antibiotics may lead to resistant strains, diarrhea, and vaginal yeast infections. Thus, there is significant interest amongst women who suffer from RUTI for novel non-antibiotic therapies.