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Hope for resistant TB as Otsuka's delamanid shows efficacy

Results come as report demonstrates rise in number of multidrug resistant cases of TB

With multidrug resistant (MDR) strains of tuberculosis reaching alarming levels in some areas of the globe, positive results from a phase II trial of Otsuka's delamanid have provided hope that a new treatment option may be on the way.

A phase II trial of the new drug, published in the New England Journal of Medicine (June 7), found that 45 per cent of patients treated with delamanid achieved a TB cure rate - defined as negative sputum culture  - compared to 29.6 per cent of the placebo group. The treatment was given on top of a background regimen of anti-tubercular drugs.

There were no dose-limiting toxicities with delamanid, although some patients on the drug showed evidence of a heart effect known as QT interval prolongation, according to the authors.

Delamanid is a new agent derived from the nitro-dihydro-imidazooxazole class of compounds that inhibits mycolic acid synthesis, and if approved would be the first new drug for tuberculosis in the last 40 years.

"Existing TB treatment regimens are long and cumbersome, which can lead to incomplete treatment, resulting in an increased risk of relapse and developing drug resistance," commented Manfred Danilovits of Tartu University Hospital in Estonia, the lead investigator in the trial.

"This study shows that delamanid … may help achieve earlier sputum conversion thereby reducing infectiousness and enhancing overall treatment options for MDR-TB," he added.

The study is published alongside another article in the NEJM which gives an indication of the pressing need for new anti-tubercular drugs. 

A survey of almost 4,000 new and previously-treated cases of tuberculosis in China in 2007 has found that 1 in 10 cases had MDR tuberculosis, and 8 per cent of these had a strain that was extensively drug resistant (XDR) to at least four of the most effective current treatments.

The authors also note that the true indigence of MDR tuberculosis has probably been under-estimated in their survey as it excluded patients in hospital who are more likely to have resistant disease.

Recognising the seriousness of the MDR-TB epidemic, Otsuka has said it intends to strictly control the distribution of delamanid - focusing initially on specialist treatment centres - in order to safeguard its effectiveness and prevent resistance from developing. Sales are predicted to be modest as a result.

According to Otsuka's latest pipeline update, delamanid has been filed for approval in its first indication in the EU, while phase III trials are ongoing in the EU, US and Japan.

Other drugs for MDR-TB coming through the pipeline include Johnson & Johnson/Tibotec's bedaquiline (phase III), the TB Alliance's PA-824 (phase II) and Sequella/PanACEA's SQ 109 (phase I).

8th June 2012

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