Industry cuts have been especially harmful to TB-drug development, with major companies no longer filling the pipeline with new TB leads. "With drug resistance on the rise, this is particularly worrying. New medicines can take a decade or more to develop. Without a strong backfill of fresh leads, there are worrying consequences for TB control in the future," commented Dr Mary Moran of Policy Cures.
Indeed, the TB world had to wait for 45 years between the introduction of rifampicin (in 1967) and the approval of the next new class drug bedaquiline (in 2012). Over 120 years elapsed between the advent of smear microscopy and the introduction of GeneXpert for the diagnosis of TB. And we are still waiting for a vaccine that can replace/improve the BCG vaccine introduced in 1921.
According to Dr Murray, "As TB was brought under adequate control in most of the developed world, innovation in tools to diagnose, treat, and prevent TB stalled. However, TB continued to be a leading killer in poorer regions. As AIDS emerged, TB exploded and received renewed attention as a global health threat. This led to resurgence in TB drug development, including the launch of TB Alliance in 2000. In the last few years, we have seen the introduction of two new drugs -- Sirturo (bedaquiline) and Deltyba (delamanid). However, these drugs have only been approved for use against MDR-TB and we are yet to see their major impact on the disease. What is needed is therapy that can transform TB treatment, making it short, simple, effective, and affordable for all.
New regimens in development, such as PaMZ, are believed to be able to usher in a new age of TB treatment and have major impact on the TB pandemic. TBA-354 was identified in collaboration with partners -- University of Auckland and University of Illinois Chicago. Once identified, TB Alliance further advanced TBA-354 through pre-clinical development and is now the sponsor of this Phase 1 study.
Shobha Shukla, CNS
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