Impending New Child-Friendly TB Treatments

TB Alliance has announced a new partnership with the U.S. Fund for UNICEF that will dramatically increase the scope and impact of child and maternal health programs around the world to include the diagnosis and treatment of pediatric tuberculosis (TB), a significant cause of child mortality.

“Pediatric TB has stayed in the shadows for far too long,” said Caryl Stern, President and CEO of the U.S. Fund for UNICEF. “We are thrilled to be working with TB Alliance to deliver new treatments that children around the world so desperately need and that will help us improve child survival.”

The collaboration will help elevate childhood TB as a priority issue to improve child survival and integrate TB within UNICEF’s child health services around the world. It will also facilitate the uptake of the first appropriate, child-friendly TB treatments that TB Alliance and its partners are developing, as part of a broader partnership with the World Health Organization (WHO), and which correspond to WHO’s recommended treatment guidelines.

“Today, there are no appropriate TB treatments for children,” said Mel Spigelman, MD, President and CEO of TB Alliance. “The partnership with the U.S. Fund for UNICEF will help ensure the new treatments coming to market can reach sick children, who can then be treated and cured.”

TB Alliance, in concert with other partners, has been working to better understand the burden of disease in children and address other issues that prevent access to TB treatment. Current estimates highlight that at least 550,000 children suffer from TB and as many as 53 million are latently infected.

UNICEF, TB Alliance, and WHO will now work together to facilitate uptake of the new child-friendly TB treatments, which are expected to reach the market in 2016. The new treatments are expected to be included in the UNICEF supply chain, one of the world’s largest purchaser and supplier of medicines and vaccines for children. The partnership will also connect the health providers in UNICEF’s global network with better educational tools and information on pediatric TB with the goal of integrating TB into existing initiatives that address maternal and child health and pediatric HIV/AIDS.

“Bringing together the relevant partners, we have an extraordinary opportunity to tackle the issue of pediatric TB,” said Mario Raviglione, MD, Director of the WHO's Global TB Programme. “We look forward to this expanded collaboration, and the impact it can have on improving TB treatment and reducing childhood mortality from TB.”

In 2013, with support from UNITAID and USAID, TB Alliance and WHO launched an initiative to improve pediatric TB treatment and reduce child mortality. The initiative aims to deliver new, correctly formulated, child-friendly TB treatments, while enhancing the market understanding needed to accelerate the time in which new and better treatments will reach children in need. This new initiative with UNICEF allows the expansion of this work by leveraging UNICEF’s global reach and presence in countries with high TB burdens.

Posted by Tim Sandle

TB Alliance Advances Next-Generation TB Drug Candidate into Clinical Testing

TBA-354 is the first potential tuberculosis drug to advance to Phase 1 trial in six years

TB Alliance has announced the start of the first human trial of a new tuberculosis (TB) drug candidate, designated TBA-354. It is the first new TB drug candidate to begin a Phase 1 clinical trial since 2009.

“There is a critical gap of new compounds for TB,” said Mel Spigelman, MD, President and CEO of TB Alliance. “The advancement of TBA-354 into clinical testing is a major milestone, not only because of the potential it shows for improving TB treatment, but because it is the first new TB drug candidate to begin a Phase 1 clinical trial in six years.”

TBA-354 comes from the nitroimidazole class of chemicals, known for being effective against drug-sensitive and drug-resistant tuberculosis. The class also includes the experimental TB drug pretomanid (formerly PA-824), which is being tested as a component of other novel regimens in multiple clinical trials.

TBA-354 emerged from studies designed to identify a next generation nitroimidazole for TB. TB Alliance conducted the studies in collaboration with the 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 the Phase 1 study.

In preclinical studies, TBA-354 demonstrated more potent anti-bactericidal and sterilizing activity compared to pretomanid. Recruitment is under way to enroll nearly 50 U.S. volunteers for the randomized, double-blind Phase 1 trial, which will evaluate the safety, tolerability, pharmacokinetics, and dosing of TBA-354.
 

The World Health Organization reported that 1.5 million people die each year from TB, and more than nine million were diagnosed with the disease. The lack of short, simple, and effective treatments is a significant obstacle to TB control. However, because there is little economic incentive to develop new tools, there are not enough promising drugs in the pipeline, which could hinder efforts to develop the appropriate treatments needed to combat the TB epidemic.

Posted by Tim Sandle

Drug resistant TB cases are 'underestimated'

The World Health Organization has estimated that at least three-quarters of drug-resistant tuberculosis cases have not been detected.

The news comes from the World Health Organization's (WHO) latest Global Tuberculosis Report. The report suggests that less than 25 percent of drug resistant cases of tuberculosis have been detected in 2012. This prevalence means that scientists are are still very far away from making real progress against this killer disease.

Tuberculosis (TB) is a common, and in many cases lethal, infectious disease caused by various strains of mycobacteria, usually Mycobacterium tuberculosis. Tuberculosis may infect any part of the body, but most commonly occurs in the lungs. Globally, tuberculosis is the second most common cause of death from infectious disease (after those due to HIV/AIDS).

Commenting on the report, Mario Raviglione, director of the WHO Global TB program, said to Nature magazine: "the debt toll of tuberculosis, a disease that is preventable and curable, is far too high."

There is a positive that can be drawn from the report: the rate of new tuberculosis (TB) cases and the percentage of people who die from the disease has continued to decline.

Posted by Tim Sandle