The search for a new tuberculosis drug after many decades and first time through a unique model of open drug discovery programme may finally bear fruits in near future, with India all set for the launch of the phase II clinical trial of the drug candidate.
The drug, coming through the Open Source Drug Discovery (OSDD) programme by Council of Scientific and Industrial Research (CSIR), will go for the clinical trials on drug-resistant TB patients in India very soon. The process of filing for permission from the Drug Controller General of India (DCGI) is on and public sector LRS Hospital for Respiratory and Infectious Diseases, New Delhi, has been selected for trials. This phase II trials will involve around 250-300 patients, sources said.
The drug candidate, Pa824, was synthesised in India long ago. After a series of ownership changes, the molecule was licensed to CSIR for further development now.
Besides completing the trials of TB drug, the OSDD programme will be expanded to cover drug discovery activities to malaria and leishmaniasis (Kala-Azar) during the coming years. It would cover open source discovery, open source drug development, open source drug delivery and open source diseases diagnostics in future.
OSDD was launched by the CSIR as a new platform for collaborative research and development, especially to address the diseases of the poor as current intellectual property-based models do not entice pharmaceutical companies to venture into such therapeutic areas.
According to estimates, tuberculosis kills hundreds of Indians daily. Almost all TB drugs currently in use were developed in the 1950s and 1960s. The last one was rifampicin in 1966. Isoniazid and pyrazinamide came in 1952 and ethambutol in 1961, as very few pharma companies showed interest in the area.