A first-in-class investigational antitubercular agent has shown early bactericidal activity with a low, once-daily oral dose after 14 days of treatment.
The Phase IIa study evaluated GSK’s GSK3036656 in participants with drug-susceptible pulmonary tuberculosis. The company hopes GSK3036656 could be a component of simpler treatment regimens in the future which could help address the TB epidemic.
Over the last decade TB was the leading cause of death due to an infectious disease globally, causing approximately 1.5 million deaths annually. Earlier this year, GSK made a commitment to invest £1bn over the next decade to accelerate R&D on infectious diseases, including TB, that disproportionately impact lower-income countries.
David Barros-Aguirre, Head of Global Health Medicines R&D, GSK, said: “Existing treatments for TB can be complicated, of long duration and have serious side effects which significantly impact the lives of patients with TB around the world. Today’s encouraging data provide a good foundation from which to investigate GSK3036656 in different combinations in Phase IIb/c studies, with the aim of contributing to shorter, simpler and better tolerated treatment regimens for patients with TB.”
The drug will now be tested in Phase IIb/c studies in different drug regimens to determine the appropriate partner agents and the optimal regimen durations. The studies will be conducted in collaboration with industry and academic partners and will be co-funded by the European Union’s IMI2 programme.