South African trial milestone signals TB drug breakthrough
Combination of three drugs able to kill TB bacteria within two weeks
A novel anti-tuberculosis (TB) drug cocktail generated encouraging results in a recent Phase II trial funded by the non-profit organisation TB Alliance.
The combination of three drugs (PA-824, a novel TB drug candidate; moxifloxacin, an established antibiotic not yet approved for use in first-line TB therapy and being developed in partnership with Bayer Healthcare; and pyrazinamide, an existing drug) in a two-week study, completed at two centres in South Africa, was able to kill more than 99% of TB bacteria found in saliva within two weeks, according to a study published this week in The Lancet.
The World Health Organization (WHO) says TB infects almost nine million people annually and is responsible for more than one million deaths each year.
The findings raise hope for a treatment breakthrough amid the growing and dangerous epidemic of drug-resistant forms of TB that, in some cases, are becoming untreatable.
The results, presented at the 2012 International AIDS Conference, also revealed progress in the development of an antiretroviral-compatible TB treatment, which is critical to treating the millions of people with TB/HIV co-infection. Today, TB remains the largest killer of people with AIDS, but very often, TB and HIV treatments cannot be given together because of drug interactions and side effects.
These results, along with pre-clinical data, suggest that this novel combination could treat both drug-susceptible and some forms of drug-resistant TB in only four months. Currently, people with multi-drug resistant TB (MDR-TB) require 18 months to two years of treatment. Even those with ordinary TB need six months of taking drugs every day.
‘These findings confirm the promise of novel TB regimens to be shorter, simpler, safer, and, compared with today’s MDR-TB drugs, much less expensive,’ said Mel Spigelman, president and ceo of TB Alliance.
An ongoing Phase IIb trial to study the drug cocktail in a larger population over a two-month treatment regimen is being conducted at eight sites in South Africa, Brazil, and Tanzania.
If the trial produces similar results to the Phase II trial, developers will likely attempt to fast-track FDA approval via the GAIN Act, which prioritises antimicrobial therapies for indications with pressing medical need.
Earlier this month, Johnson & Johnson submitted an application for accelerated FDA approval for bedaquiline, a compound with activity against drug-resistant TB. The novel drug cocktail and Otsuka Pharmaceuticals’ delamanid could soon join bedaquiline in the race to become the first novel TB therapy in almost 50 years.
The TB Alliance is a product development partnership between public and private organisations dedicated to developing novel TB therapies. Since its inception in 2000, the TB Alliance has developed the world’s largest TB drug portfolio and established connections with stakeholders on a global and national scale. The organisation is, therefore, uniquely positioned to develop and distribute novel TB therapies.
