Japanese drugmaker Otsuka Pharmaceutical (TYO: 4578) has announced Phase IIb clinical trial results on the safety and efficacy of delamanid, the company’s investigational compound for the treatment of multidrug-resistant tuberculosis (MDR-TB), published in the New England Journal of Medicine, which could lead to the first new TB treatment in more than four decades.
Results from the trial showed a 53% increase in sputum culture conversion (SCC) after two months between study subjects receiving delamanid 100mg twice-daily (BID) plus a background regimen (BR) consistent with WHO treatment guidelines compared with subjects receiving placebo plus BR alone.
Study findings
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