Otsuka announces efficacy results for delamanid for extensively drug-resistant tuberculosis

Data from a post-hoc subset analysis of Phase IIb clinical trials suggests the potential efficacy of Otsuka’s delamanid for the treatment of extensively drug-resistant tuberculosis (XDR-TB).

The analysis found that patients receiving delamanid, plus a World Health Organisation (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. 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.

“XDR-TB is one of the most deadly and difficult forms of TB to treat,” said Dr Andra Cirule, one of the lead study investigators and a tuberculosis specialist at Riga East University Hospital in Latvia. “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.”

WHO has added delamanid to its Essential Medicines List

XDR-TB develops from misuse or mismanagement of second-line TB therapies, which severely limits treatment options. 100 countries have reported at least one case of this dangerous strain, including the US, where contract tracing is currently ongoing after an infected patient exposed individuals in at least three states to the disease.

“The study’s important findings reaffirm Otsuka’s commitment to continued research on this major global health threat,” said Masuhiro Yoshitake, executive operating officer of Otsuka and TB Global Project leader. “For over 40 years, Otsuka has made it a priority to identify new treatment options for even the most challenging TB cases, and we look forward to continued progress against this deadly strain.”

Delamanid is the first compound from a novel drug class is bactericidal and specific to Mycobacterium tuberculosis, including multidrug-resistant (MDR-TB) strains. It has received regulatory approval in the EU, Japan and the Republic of Korea. In October 2014, WHO released its interim policy guidance for the use of delamanid in the treatment of MDR-TB and in May 2015, the WHO added delamanid to its Essential Medicines List, which includes medicines based on the scientific evidence of their comparative effectiveness, safety, and cost-effectiveness.

The trial findings are reported in New England Journal of Medicine.