The following is a guest posting from Joanna Breitstein of the TB Alliance, reporting from Addis Ababa, Ethiopia.
While there were few new TB treatment prospects a few years ago, today there are 10 drugs in the global development pipeline. Noting the sea of change, Wednesday’s Open Forum conference focus shifted from developing drugs to speeding them through development and to the patients that need them. “Having new treatments in and of itself is not enough to impact the TB epidemic,” said Dr. Mel Spigelman, CEO and President of the TB Alliance.
More than 160 regulators, scientists, National Treatment Program (NTP) managers, and other TB stakeholders gathered in Addis Ababa, Ethiopia, to attend the conference and address key issues in developing new drugs for treatment of TB. The two-day meeting was the fourth in a series on the subject, with a special focus on regulatory affairs.
A large focus of the meeting was the Critical Path to TB drug Regimens (CPTR), a new initiative that includes an innovative clinical design structure for TB drug trials, which enables researchers to test regimens instead of just individual compounds, offering the potential to dramatically shorten the drug development timetable.
“The CPTR approach will become the gold standard for rapid, safe, and effective testing and development of new TB drug combinations,” said Jan Gheuens, of the Bill & Melinda Gates Foundation. Researchers noted that there are already several new pre-clinical TB drug combinations in development that look more promising than the current standard of treatment.
However there are still barriers that could slow down approval time of new drug regimens. In particular, many African NTP managers noted that they took guidance from the World Health Organization (WHO) on approval, and stressed the importance of WHO’s development of clear protocol and guidance to evaluate such a new trial structure.
Attendees noted that not nearly enough was being done to tackle TB. Dr. Haileyesus Getahun, from the Stop TB Partnership, said the problem was particularly acute in Africa. When discussing progress with the Millennium Development Goals, “TB treatment success has been reached globally, but not in Africa,” he said.
Dr. Tony Moll, from Tugela Ferry Hospital in Kwazulu-Natal, South Africa, noted the significant challenge posed by TB-HIV co-infection. However, movement is in the right direction and, “We’re now at a point where there is collaboration between TB and HIV treatment providers,” he said. “The next step is treatment integration.”
Many other issues were addressed including the scale-up of multiple drug resistant TB (MDR-TB) treatment. Dr. Hind Satti from Partners in Health shared her experience in Lesotho, where they have implemented an MDR treatment structure.
But perhaps the biggest hot button issue was compassionate use programs and the coming plans for pre-approval access to TMC-207, a Phase II clinical trial drug being developed by Tibotec and the TB Alliance for TB and MDR-TB. Dr. Brian Woodfall of Tibotec noted that there were already discussions underway about how to make this access possible, drawing on the company’s broad experience in early access HIV drug programs. He noted the key was having a reasonable amount of data to understand drug efficacy and ensure the safety of the patient. Woodfall expects more data to be published on TMC-207 before the end of the year.