Delamanid (Otsuka) positive in Phase IIb trial for Tuberculosis

Otsuka Pharmaceutical Co., Ltd. announced clinical trial results on the safety and efficacy of delamanid, the company's investigational compound for the treatment of multidrug-resistant Tuberculosis (MDR-TB).Results from the Phase IIb trial showed a 53% increase in sputum culture conversion (SCC) after two months between study subjects receiving delamanid 100 mg twice-daily (BID) plus a background regimen (BR) consistent with WHO treatment guidelines compared with subjects receiving placebo plus BR alone. Otsuka has already filed the drug at the EU and is in talks with regulators in the U.S. and Japan. If approved this will be the first new drug for Tuberculosis in 40 years.see published in the New England Journal of Medicine online at http://www.nejm.org/doi/full/10.1056/NEJMoa1112433