Positive results for Otsuka's Deltyba for extensively drug-resistant tuberculosis

Japanese drugmaker Otsuka Pharmaceutical (TYO: 4768) says that data from a post-hoc subset analysis of its Phase IIb clinical trials suggesting potential efficacy of Deltyba (delamanid) for the treatment of extensively drug-resistant tuberculosis (XDR-TB) has been reported in the latest issue of the New England Journal of Medicine.

The analysis found that patients receiving delamanid, plus a World Health Organization (WHO)-recommended optimized background regimen (OBR), had a higher proportion of 2-month sputum culture conversion (SCC), a measurement by which patients are no longer infectious, compared to patients receiving placebo plus OBR alone (7/16, 43.8% versus 1/10, 10%, p=0.0989). In this same open-label analysis, mortality trended lower when patients received six months or more of delamanid compared to patients treated for two months or less (0/17, 0% vs 2/9, 22.2%, p=0.11).

"XDR-TB is one of the most deadly and difficult forms of TB to treat,” said Andra Cirule, one of the lead study investigators and a tuberculosis specialist at Riga East University Hospital in Latvia, adding: “More new medicines are urgently needed to prevent XDR-TB from becoming a death sentence and this analysis shows that delamanid may be an effective option to improve the current standard of care.”