A 14-day trial enrolling 75 Cape Town South Africa patients, to see if a new investigational drug lowers tuberculosis bacteria counts represents the latest hope for filling the need for treatment options for the disease, the National Institutes of Health announced this week. The NIH is sponsoring the trial led by Case Western Reserve researchers assessing a drug developed by London-based pharmaceutical company AstraZeneca.
Nearly half a century since the last drug targeting the disease was licensed, and two decades after the World Health Organization called the global impact of tuberculosis an emergency, drug resistant strains of the disease have flourished, in part because treatments even for drug-sensitive forms of the disease remain limited, lengthy and harsh, requiring 6-month drug regimens that are difficult to complete. Treatments for drug-resistant strains, extending over two years, are more limited, more punishing. Nearly 9 million people became infected with tuberculosis last year, and 1.4 million people died of the disease.
The progress of a new drug added to the phase II column of the chart above is exciting, Christine Sizemore, Chief of the TB, Leprosy and other Mycobacteria Diseases section of the NIH says.
“Working in the field, where there is relatively little industry participation, we need to expand the toolbox,” she said. Only a handful of drugs with new mechanisms for curing tuberculosis are in development, with drugs already approved for uses against other diseases being tested for effectiveness against tuberculosis making up the rest of the list of potential future treatments. she notes. The logistics of drug development mean that in the event that this most recent investigational drug proves to be safe and effective it likely won’t be available to patients for another five to seven years, she said.
In laboratory testing, the drug has shown effectiveness against drug-sensitive and drug-resistant strains of tuberculosis bacteria and in preliminary clinical testing it has been well-tolerated, according to the NIH. All participants in the Cape Town trial will receive the drug, randomly assigned to study groups receiving different dosages. Some participants in the study will be people who also have HIV, but are not yet receiving anti-retroviral treatment, according to country standards, Sizemore says.