The maiden human trial of a potential tuberculosis drug — the first in six years — has now commenced.
Known as TBA-354, the promising drug comes from a class of chemicals known to be effective against drug-sensitive and drug-resistant tuberculosis, deemed a major public health concern because it can derail progress made in TB treatment and care. The proportion of drug-resistant TB of the global TB numbers has stayed at the same level in recent years, but new cases rise by almost half a million annually, according to the World Health Organization.
Although considered a milestone, this news also hints at the sad state of research and development for TB drugs.
“TB, by and large, is a problem of the poorest of the poor,” Dr. Stephen Murray, senior medical officer at TB Alliance, which is spearheading the trial, told Devex. “As such, research for new TB treatments has long been dramatically underfunded.”
WHO pegs TB R&D financing needs at $2 billion per year. But in 2013, funding only amounted to $676.7 million — roughly a third of the requirement — according to the Treatment Action Group’s most recent report on TB research funding trends.
And that’s because more and more pharmaceutical companies are exiting the field. Most of the 2013 funding came from public donors and charitable foundations, most notably the U.S. National Institutes of Health and the Bill & Melinda Gates Foundation.
Murray noted that as a drug candidate progresses through the development process, each successive stage requires more resources and expertise — a commitment that many for-profit drug companies are hesitant to make and expertise that academic institutions don’t have.
Overcoming the financial and expertise gap, though challenging, is not impossible, Murray argued. One way to bridge the gap is to make sure that product development partnerships are sufficiently funded “as they are the groups most willing and qualified to take on this work when those involved in the earlier stages do look to hand off such programs.”
The senior medical officer suggested creating more and better incentives for the pharmaceutical firms to increase their investment in neglected disease R&D. Murray also suggested extending their involvement along the entire drug development chain — including through innovative financing mechanisms — and cited the Gates Foundation’s TB Drug Accelerator Program and the Global Health Innovative Technology Fund as two such initiatives that are helping to stock the global pipeline of TB drug candidates.
TB Alliance, for its part, runs almost 20 drug discovery programs and considers TBA-354 as “the first of a steady stream of clinical stage drug candidates” to be delivered over the next several years.
The alliance is now recruiting nearly 50 U.S. volunteers for the trial, which will involve evaluating the drug’s safety, tolerability, dosing and pharmacokinetics — or how the drug is released, absorbed and metabolized in the body.