*updated 3 p.m.*
The enrollment of nearly 50 volunteers in the United States will launch the first randomized clinical trial of a potential new drug to treat TB in six years, the nonprofit product development partnership TB Alliance announced Wednesday. Assuming the trial yields good news, that means a new TB drug could reach people who need it in 10 to 15 years, a process that could be sped some with adequate funding, according to the organization.
Even with that delayed gratification as a best case scenario, in the world of new treatments for tuberculosis, the step forward this represents is a “major milestone,” the announcement from TB Alliance said. This is a world where the first new anti-TB drug to win regulatory approval in 40 years began clinical trials in the early 2000s, got accelerated approval at the end of 2012, and where work continues now to get the drug into the hands of people who need it. It also is a world where momentum has lagged, with the pharmaceutical industry pulling back from new TB drug development, and the 2013 sequestration of U.S. spending dealing the National Institutes of Health — one of TB Alliance’s funders — a 13 percent funding cut. according to the December-released G-Finder global funding for infectious diseases report. In its October-released 2014 Report on Tuberculosis Research Funding Trends, the research advocacy Treatment Action Group called the state of tuberculosis research and development “shakier” than it has been in the five years the group has been tracking it. Now the quest to fight global epidemics of drug-resistant tuberculosis also is confronting the possibility of a 19 percent, or $45 million cut to USAID’s TB program proposed in the President’s budget for fiscal year 2016.
All this comes at a time, the announcement from TB Alliance points out, when challenges to effective tuberculosis treatment — including its duration and side effects, as well as drug resistance — hobble efforts to control the spread of disease estimated to kill more than one and a half million people yearly.
“What’s exciting is that there was a gaping hole at Phase 1 for a long time,” Erica Lessem of TAG said. She added that having more candidates at Phase 1 is important, because the series of clinical trials necessary to prove a drug is safe and effective, and can be marketed, narrow down the candidates: “sort of like a funnel.”
“We need a number of different candidates, from a number of different drug classes,” Lessem said.
The new drug candidate, called TBA-354, comes from a class of chemicals shown to be effective against both drug-sensitive and drug resistant tuberculosis. It is from the same class as delamanid, a new drug that was approved by the European Medicines Agency at the end of April, as well as pretomanid, another drug currently under development. TBA-354 showed more potency than pretomanid against the bacteria in preclinical testing, according to TB Alliance. Coming from a proven class of drugs is promising, but if resistance to other drugs from that class — at this point delamanid — develops, that resistance also will compromise the effectiveness of the new drug.