Effective tuberculosis (TB) combination therapies could reach patients much sooner under an initiative announced this week.
The Critical Path to TB Drug Regimens (CPTR) initiative — launched yesterday (18 March) — seeks to unite academics with private and public sector organisations to test promising combination therapies for TB.
Drugs combined in potentially winning formulas will be tested and approved together rather than going through the usual lengthy process of approving them one at a time. The new combinations will be selected from old and new drugs that have passed initial safety and dosing tests but have not undergone prolonged treatment trials in patients.
CPTR is liaising with the US Food and Drug Administration to ensure new combinations are given rapid approval at the end of the development process.
The initiative is the logical way forward and in everybody's best interests, said Melvin Spigelman, president and CEO of the Global Alliance for TB Drug Development, the organisation that co-created CPTR.
TB drugs are particularly suitable for the initiative's fusion approach to drug development as combination therapies are essential in the treatment of TB to avoid multidrug resistance. Moreover, therapies developed under the initiative are expected to cost hundreds of millions of dollars as opposed to the billions normally required to develop a single new drug as running combination trials reduces costs when compared with running one trial at a time.
Spigelman says he is optimistic that one or two new drug combinations could revolutionise the treatment of TB — and these combinations may well come from one of nine drugs currently working their way through the development pipeline.
A new TB therapy would normally take around 24 years to develop, but through CPTR, an effective combination could be available in the developing world in six to seven years, Spigelman told SciDev.Net.
But Spigelman added that it is still important to "continuously fill the pipeline and put new drugs into clinical development".
Initial funding for CPTR has come from organisations including the Bill & Melinda Gates Foundation — a co-creator of the initiative — the US Agency for International Development, the UK Department for International Development and pharmaceutical companies involved in TB-related research. Spigelman said more funds will be sought.
Nani Nair, the WHO's Regional TB Advisor for South-East Asia, said that although at present the use of old drugs in fixed-dose combinations is helping to keep resistance at bay, "if [CPTR] could come up with a new drug combination that could be given once a day for a shorter duration without too many side effects, that would be a significant step forward in TB control".