Cape Town - Local tuberculosis experts are optimistic that a novel TB antibiotic, which is being tested on multidrug-resistant TB sufferers in a Cape Town hospital, could revolutionise treatment of the killer disease.
Delamanid, which was tested on about 70 patients in the Brooklyn Chest Hospital, showed impressive results within the first two months of treatment.
It was provisionally approved for marketing by the European Medicines Agency following its positive results in more than 500 MDR TB patients on which it was tested around the world.
It has not yet been registered by South Africa’s regulatory body, the Medicines Control Council.
Used in combination with other anti-TB medicines, Delamanid was the second new TB drug to receive a positive opinion from the US Food and Drug Administration and the European Medicines Agency after Bedaquiline in several decades.
Dr Florian von Groote-Bidlingmaier, director of the Stellenbosch University Task Applied Science, tested the new drug on patients at the Brooklyn hospital.
Early results were so promising that it could potentially be part of the new regimen for MDR patients.
“South Africa has one of the highest burdens of tuberculosis in the world. New drug regimens are urgently needed to treat patients, especially patients with drug resistant tuberculosis.
“Delamanid could potentially be part of a new regimen which would be available to patients in South Africa.”
Specifically developed by the Japanese pharmaceutical company Otsuka to treat TB which is resistant to existing drugs, Delamanid’s early results after a two-month treatment period showed that 45 percent of patients on it showed positive results compared to only 30 percent on placebos.
The phase 3 trial, which has just completed recruiting patients, is expected to be completed in 2016.