https://www.cidrap.umn.edu/news-perspective/2022/11/gsk-reports-positive-phase-2-results-new-tb-drug
GSK reports positive phase 2 results for new TB drug
Filed Under:
Tuberculosis;
Antimicrobial Stewardship
British drugmaker GSK announced yesterday that its investigational tuberculosis (TB) drug produced positive results in a phase 2a study.
GSK said the results of the single-center, open-label trial showed that GSK3036656, a first-in-class antitubercular agent that suppresses protein synthesis in Mycobacterium tuberculosis, demonstrated early bactericidal activity and was well tolerated after 14 days in patients with drug-sensitive pulmonary TB. The trial involved four cohorts of 12 to 20 patients who were randomized to receive 1, 5, 15, or 30 milligrams (mg) of GSK3036656 or the standard-of-care drug.
Anti-mycobacterial activity for doses of 5 to 30 mg was demonstrated in terms of reducing the number of viable TB cells and an increase in the time to detect bacterial growth in culture. Positron emission tomography also showed a reduction in TB disease in participants who received 30 mg.
Company officials say the findings suggest GSK3036656 could be part of a shorter and simpler TB treatment regimen.
"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," David Barros-Aguirre, PhD, GSK's Head of Global Health Medicines R&D, said in a company press release. "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."
GSK reports positive phase 2 results for new TB drug
Filed Under:
Tuberculosis;
Antimicrobial Stewardship
British drugmaker GSK announced yesterday that its investigational tuberculosis (TB) drug produced positive results in a phase 2a study.
GSK said the results of the single-center, open-label trial showed that GSK3036656, a first-in-class antitubercular agent that suppresses protein synthesis in Mycobacterium tuberculosis, demonstrated early bactericidal activity and was well tolerated after 14 days in patients with drug-sensitive pulmonary TB. The trial involved four cohorts of 12 to 20 patients who were randomized to receive 1, 5, 15, or 30 milligrams (mg) of GSK3036656 or the standard-of-care drug.
Anti-mycobacterial activity for doses of 5 to 30 mg was demonstrated in terms of reducing the number of viable TB cells and an increase in the time to detect bacterial growth in culture. Positron emission tomography also showed a reduction in TB disease in participants who received 30 mg.
Company officials say the findings suggest GSK3036656 could be part of a shorter and simpler TB treatment regimen.
"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," David Barros-Aguirre, PhD, GSK's Head of Global Health Medicines R&D, said in a company press release. "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."