New drug brings hope of faster TB cure

The most aanced drug yet for treating multi-drug resistance tuberculosis (MDR-TB)ould be available by 2018.

The TB Alliance has announced that it is aancing the global clinical trial into phase 3 — the last stage of clinical trials — to determine the safety and efficacy of the new TB drug regimen known as PaMZ.

The Phase 3 trials are scheduled to start later this year in Uganda, Tanzania, Kenya, Zambia and South Africa. Other studies will be conducted in Asia, Eastern Europe and Latin America.

PaMZ is expected to significantly reduce the time required to cure drug-resistant TB from two years to just six months, and it could cut the cost of curing drug-resistant TB in low-income countries.

The results from early research suggest that this new drug regimen could provide the breakthrough to finding a cure for this deadly disease. It is expected to save the more than 1.3 million people who die annually from the disease, especially people co-infected with HIV.

In East Africa, Kenya, Tanzania and Uganda are ranked among 45 high TB burden countries in that order. In 2013, the World Health Organisation said that Kenya recorded 225 newly confirmed cases of MDR-TB, followed by Uganda, which recorded 89 new cases, then Rwanda with 58, Tanzania 42, and Burundi with 24.

TB Alliance president Mel Spigelman said the results are expected in 2017 and, if successful, the organisation will pursue registration of the drug combination to make it available to all who need it.

“If the phase 3 trials are completed without delay and results are positive, the PaMZ regimen could reach the market in 2018,” said Dr Spigelman.

The treatment and cure of drug-resistant TB currently takes between six and nine months and the therapy is long, complicated, and can cause severe side effects.

According to Eunice Wahome, a TB specialist at the Kenyatta National Hospital, people with drug-resistant TB require 18 to 24 months of treatment.

“This extensive therapy requires more than 12,000 pills and daily injections for at least six months,” said Dr Wahome. “The long duration of MDR-TB treatment, combined with the pain and side effects that treatment causes, explains why only 53 per cent of patients who enter therapy for MDR-TB complete it.”

PaMZ is a three-drug regimen comprised of two candidate drugs that are not yet licensed for use against TB: PA-824 and moxifloxacin, and one existing antibiotic used in TB treatment today, pyrazinamide. It will be tested in a three-phase clinical trial named STAND (Shortening Treatments by Aancing Novel Drugs).

“If successful, the regimen would eliminate the need for injectable drugs and reduce the cost of MDR-TB therapy in some countries by more than 90 per cent in those patients whose TB organisms are sensitive to the three drugs,” said Dr Spigelman. “It also promises to be compatible with commonly used HIV drugs, helping the millions of people co-infected with TBHIV.”

Earlier studies show PaMZ’s potential to treat both drug-sensitive and drug-resistant patients with the same oral therapy.

In July 2012, a two-week study, whose results were published in The Lancet, showed that PaMZ appeared to kill the patients’ bacteria faster than standard therapy after starting treatment. Findings from a subsequent two-month study are expected to be published later this year.

The TB Alliance is also developing other novel regimens, which are in phase 2 trials. Results of REMox TB, a phase 3 trial testing a new treatment for drug-sensitive TB, are expected later this year.

SOURCE: The East African