NIH launches Phase 3 trial for promising TB drug in 12 countries

M Somasekhar Hyderabad | Updated on October 31, 2019

The National Institute of Health (NIH), US, has committed $70 million for the Phase 3 global clinical trials to prevent MDR-TB among people at high risk, especially children and adults who are exposed to members with the disease in households.

The landmark trials have been launched in 12 countries including India (Pune and Chennai). The global effort under a public-private partnership will involve Otsuka Pharmaceuticals Ltd, the Japanese maker of the drug ‘delamanid’, according to Peter Kim, Director at the National Institute for Allergy and Infectious Diseases (NIAID), which is part of the NIH.

Talking to the international media at the ongoing 50th Union World Conference on Lung health (WCOLH). Kim said: “We at NIH believe that global diseases like TB requires global collaboration. India is an important player in the initiative and we have a strong partnership with the Department of Biotechnology (DBT). TB is one of the diseases with the highest mortality”.

The project is called PHOENIx MDR-TB, or Protecting Households on Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients. The study is co-funded by NIAID and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, also part of NIH.

The study will compare the safety and efficacy of delamanid, with the existing TB drug ‘isoniazid’ for preventing active MDR-TB disease in children, adolescents and adults at high risk who are exposed to adult household members with MDR-TB. Study participants are at high risk for MDR-TB because they either have latent TB infection, immune systems suppressed by HIV or other factors, or are younger than age 5 years, and therefore, have a weak immune system, a NIH statement says.

Published on October 31, 2019

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