TB Alliance launches five-country phase 2 clinical trial evaluating next-generation TB drug
TB Alliance press release (11/16)
TB Alliance has launched a new pan-phase 2 clinical trial to evaluate the safety and efficacy of replacing bedaquiline with a new experimental compound, TBAJ-876, in the organization’s three-drug BPaL regimen. The new regimen, composed of novel compounds with minimal pre-existing resistance, could provide a method to treat all patients with active tuberculosis (TB), including drug-sensitive and drug-resistant TB, with a universal treatment that is shorter, simpler, and more people-friendly than current regimens. Results from the preclinical and phase 2 studies showed that TBAJ-876, compared to bedaquiline, eliminated TB bacteria faster and was potentially safer. The study aims to enroll 300 participants with drug-sensitive TB at 21 trial sites in Georgia, the Philippines, South Africa, Tanzania, and Uganda.
No more needles? Gates Foundation funds patch-style vaccine technology
Reuters (11/16), features the Bill & Melinda Gates Foundation
Last week, the Bill & Melinda Gates Foundation announced a $23.6 million grant to US-based life science company Micron Biomedical to fund the first-ever mass production of needle-free vaccine technology. The technology, which uses dissolvable microneedles attached to the skin via a patch-like device, has the potential to boost the uptake of a variety of injectables, particularly in low-income countries, because it is simpler to transport and easier to administer. Specifically, the funding will support the development of a manufacturing facility that can make around 10 million doses annually for large clinical trials and hopefully wider use, subject to approval from regulatory authorities.
Study: Common antibiotic reduces risk of drug-resistant tuberculosis
A phase 3 clinical trial in South Africa found that a widely available oral antibiotic, levofloxacin, was safe and substantially reduced the risk of children and adults developing multidrug-resistant tuberculosis (MDR-TB). The trial is the first high-quality study to look at a preventive treatment for MDR-TB in children—there are currently no preventive MDR-TB treatments for adults or children. The researchers hope the new results will lead to updated guidelines from the World Health Organization that will lead to the rapid scale-up of levofloxacin because the drug is already widely available and relatively affordable, with child-friendly formulations already available through procurement agencies.