GSK3036656 demonstrates early bactericidal activity with a low, once-daily oral dose after 14 days of treatment.
Results from a phase 2 study, investigating a first-in-class investigational antitubercular agent, GSK3036656 (GSK), demonstrated that the drug was well tolerated and showed early bactericidal activity with a low, once-daily oral dose after 14 days of treatment for individuals with drug-susceptible pulmonary tuberculosis (TB).
The results demonstrate the potential for the drug to be a component of future treatments to address the TB epidemic, investigators said.
“The data show that GSK3036656 is a potential new antibiotic for [TB] that can be used in low, once daily doses. This can help reduce [adverse events (AEs)] and is an important characteristic of any new TB drug,” Andreas Diacon, MD, PhD, chief scientific officer at TASK, said in a statement.
“GSK3036656 is of a completely new class of antibiotics which makes the chance of drug resistance very low,” he said.
Results showed that the anti-mycobacterial activity reduced the number of viable TB cells, which can multiply, and increased the time to detect bacterial growth in culture.
Additionally, positron emission tomography-computed tomography scan imaging of the lungs showed a reduction in disease over 14 days for all individuals taking the drug in the 30-mg dosage.
GSK3036656 was offered in doses ranging from 5 to 30 mg, which all showed bactericidal activity by the 14-day endpoint, with the 30-mg dosage having the highest bactericidal activity.
“Existing treatments for TB can be complicated, of long duration, and have serious [AEs] 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 2b/c studies, with the aim of contributing to shorter, simpler, and better-tolerated treatment regimens for patients with TB,” David Barros-Aguirre, head of global medicines research and development at GSK, said in the statement.
Investigators found that the drug was generally well tolerated, with no serious AEs identified during the study. The percentage of individuals who reported AEs was similar between the standard of care and the investigational drug. There were also no significant differences between the investigational drug and the standard of care or the investigational drug dose-related trends.
The antitubercular agent will be evaluated in phase 2b/c studies in different drug regimens to determine the appropriate agents that will complement the anti-TB action and achieve the optimal regimen durations.
Investigators hope to identify a GSK3036656-containing regimen with sufficient tolerability, efficacy, and a short enough duration to move the drug to phase 3 trials with a high probability of success.
A selection of data was presented as an oral large breaker session at the Union World Conference on Lung Health.
GSK will work in partnership to develop new TB medicines and vaccines, focusing on research and early development as well as partnering with world-leading organizations and funders on late development, manufacturing, and access to maximize the impact for individuals with TB.
GSK announces positive phase 2a study results for a new first-in-class candidate medicine for patients with tuberculosis. News release. GSK. November 14, 2022. Accessed November 14, 2022. https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-phase-iia-study-results-for-a-new-first-in-class-candidate-medicine/