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Results from a multinational
clinical trial of a novel antibiotic show the drug cleared multidrug-resistant
TB from the lung fluid of 45.4 percent of patients after two months.
Delamanid, developed by Otsuka
Pharmaceutical Co., was given to study volunteers along with a standard TB drug
regimen. Those who received delamanid were much more likely to see the bacteria
eliminated from their sputum - a “conversion” of sputum cultures - than those
who received only the older drugs, said Lawrence Geiter, a vice president at
Otsuka and an author of the study. The trial took place in 17 medical centers
across nine countries.
“We saw what we think is a
reasonable safety profile,” Geiter said. “[So] this could be the first new
class of TB compounds that would be licensed in nearly a half century.”
Geiter noted concern over the 13
percent of patients receiving the highest dose of delamanid who showed
prolonged periods between heartbeats. Ten percent of patients receiving the
lower dose also had a prolonged QT interval, compared with just 3.8 percent in
the placebo group. “This is something we’ll continue to look at,” he said.
In an accompanying editorial, Drs.
Richard Chaisson and Eric Nuermberger of the Johns Hopkins University School of
Medicine called the study results “significant but modest.”
“Any new class of TB drugs is
expected to work against drug-resistant strains because they haven’t had a
chance to become resistant to it. That’s the easier part in making a dent in
TB,” explained Scott G. Franzblau, director of the Institute for Tuberculosis
Research at the University of Illinois-Chicago, who was not affiliated with the
study. “The harder part is, can you really get a drug that will help you
shorten treatment?”
A study examining six months of
delamanid treatment and patient follow-up for 30 months is underway.
[PNU editor’s note: The study,
“Delamanid for Multidrug-Resistant Pulmonary Tuberculosis,” and the editorial,
“Confronting Multidrug-Resistant Tuberculosis,” were published in the New
England Journal of Medicine (2012;366:2151-2160 and 2223-2224, respectively).]
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