In a step toward shorter tuberculosis treatment, GSK reports positive mid-stage data for antibiotic

16 Nov 2022
endpts.com
Clinical ResultPhase 2Phase 1
GSK says an experimental tuberculosis drug has delivered positive results in a Phase IIa, paving the way for combination regimens that can be tested in Phase IIb/III trials. The candidate, dubbed GSK3036656, originated from a 11-year collaboration with Anacor Pharma. In the mid-stage study, a low, once-daily oral dose of the drug showed early bactericidal activity after 14 days of treatment. It marks the second antibiotic win for GSK in days, after the pharma giant — one of a few still in this space — claimed success in two large clinical trials on a new antibiotic for uncomplicated urinary tract infections. Wrapping the trials up early, GSK said it will be filing for FDA approval next year. In the Phase IIa tuberculosis trial, investigators tracked samples from patients with drug-susceptible pulmonary tuberculosis and found that GSK3036656 lowered the number of viable tuberculosis cells, meeting the primary endpoint. On a key secondary endpoint, the drug also increased the time it took to detect growth in culture. Both were measured over a period of 14 days. Typically, people with tuberculosis are prescribed six months of treatment. “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,” said David Barros-Aguirre, GSK’s head of global health medicines R&D, in a statement. The hope is that GSK3036656, which targets an enzyme on Mycobacterium tuberculosis known as leucyl-tRNA synthetase, can serve as a component to shorter, simpler and better tolerated treatment regimens. A total of four doses were tested in the trial: 1 mg, 5 mg, 15 mg and 30 mg, alongside a control arm given standard of care antibiotics. For those taking the highest dose (which showed the most bactericidal effect), PET CT imaging of the lungs also showed a reduction in TB disease over 14 days. With the threat of drug resistance — public health experts have warned of doomsday scenarios where even simple infections could become deadly — looming over antibiotics. GSK has emphasized that the drug belongs in a new class, which can mean a lower risk of resistance. Together with industry and academic partners, GSK will now look to identify the appropriate drugs to pair with GSK3036656 and put them into late-stage studies.
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