ICMR to test efficacy of two new TB drugs in clinical trials

With India set to witness a steep rise in the number of drug-resistant tuberculosis cases, the Indian Council of Medical Research (ICMR) will test the efficacy of two new medicines for tackling the dreaded bug that causes TB.

One of the medicines, Metformin, is widely used to treat type-II diabetes. However, ICMR plans a clinical trial to examine its effectiveness in fighting the TB microbe following encouraging scientific results from Indian biologists.

The second drug is Bedaquiline that received the US Food and Drug Administration’s approval in 2012 for the treatment of drug-resistant tuberculosis cases. It is yet to be used in India’s public-funded national TB control programme.

“The protocol for the Metformin trial is ready and we hope to start the trial within a couple of months. The Bedaquiline Delaminate (another new drug) trial for drug-resistant cases may take about six months to kick off,” ICMR director general Soumya Swaminathan told DH. The Metformin trial would be held in two steps.

First, there would be a phase-II proof-of-concept trial on a limited number of patients to examine the safety of the drug in TB treatment. It would be followed by a larger trial on the medicine’s efficacy as well as for dose determination.