Clinical trials for TB drugs are presently based on standard treatment regimens requiring 6-9 months of therapy, with efficacy evaluation taking another 1-2 years to measure relapse rates in those patients who have not been successfully cured.
In total, clinical trials required to register a TB drug can take a minimum of six years, much longer than trials for other infectious diseases. The result is high drug development costs and long delays in introducing new medicines. The identification of biomarkers could streamline and accelerate the process.
“Biomarkers offer a more predictable and less costly avenue in product development; nowhere is this more badly needed than in developing drugs for TB,” said Dr Pieter Muntendam, president and CEO of BG Medicine.
A biomarker is a quantifiable biochemical characteristic – such as a metabolite, hormone or enzyme – that is measured and evaluated as a pharmacologic response to therapy.
Having such markers facilitates decision-making in the drug development process, enabling earlier decisions, for example, as to whether to terminate a compound’s development or advance it into late stage clinical trials.