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Drug-resistant TB treatment regimen enters phase 3 trial
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A drug regimen designed to treat drug-sensitive and some forms of multi-drug resistant tuberculosis is entering a global phase 3 clinical trial, according to an announcement TB Alliance made during the Global Health Product Development Forum.
PaMZ (Shanghai Fosun Pharmaceutical and Fosun Pharma) is comprised of two candidate drugs, PA-824 and moxifloxacin, in combination with the antibiotic pyrazinamide. Previous study results have shown the regimen has potential to treat both drug-sensitive and drug-resistant TB with the same oral therapy. The regimen significantly shortened treatment time for some patients and early trials have shown the drug is efficacious.
“The results from early phase research suggest that this new drug regimen could provide the breakthrough we need to accelerate progress against this deadly and dangerous disease. PaMZ could dramatically reduce the time required to cure drug-resistant TB from 2 years to just 6 months, and it could cut the cost of curing drug-resistant TB in low-income countries from thousands of dollars to just a fraction of that cost,” Bill Gates, co-chair of the Bill and Melinda Gates Foundation, said during the forum, adding that the Gates Foundation would provide significant funding for the trial.
Patients with drug-resistant TB require a minimum of 18 to 24 months of treatment. Current therapy includes numerous pills and daily injections for at least 6 months. This regimen may explain why only 53% of patients who enter therapy for MDR-TB fully complete treatment.
“TB patients, especially those with drug-resistant TB, urgently need cures that eliminate the need for injectable therapies, require taking fewer pills for a shorter period of time, are less toxic, simpler to administer, and cost much less money. The STAND trial brings us closer to an era of high-impact drug regimens instead of where we are today, relying on the relics of the mid-20th century,” Mel Spigelman, MD, president and chief executive officer of TB Alliance, said at the forum.
The Shortening TB Treatment by Advancing Novel Drugs (STAND) trial will include 50 study sites across Africa, Asia, Eastern Europe and Latin America. The trial aims to evaluate PaMZ as a shorter, simpler, and safer treatment for drug-sensitive and drug-resistant TB.
TB Alliance announced it will collaborate with the drug manufacturers to develop and commercialize PaMZ for use within the People’s Republic of China, Taiwan, and the licensed territory of Hong Kong and Macau.
Approximately 1 million people in China contract TB each year, and an estimated 50,000 of those cases are MDR-TB, according to a report from the National Health and Family Planning Commission of the People’s Republic of China. The report also states China has the second largest TB epidemic in the world.
“This collaboration is emblematic of the type of innovative partnerships needed to truly advance global health technologies. Through this partnership, Fosun Pharma will both help support the global registration of urgently needed new tools for TB, while also retaining the benefits of a traditional product developer within their core market; this is the sort of agreement that product development partnerships are able to achieve to benefit the millions of patients needlessly dying from neglected diseases of poverty such as TB,” Spigelman said.