Dr. Nibedita Rath and her team are conducting a randomized, controlled, open-label Phase III trial to evaluate the efficacy and safety of metformin in improving lung function and resolving pulmonary cavities in patients with pulmonary tuberculosis (PTB) who have completed their drug-sensitive/drug-resistant treatment. This trial builds on previous Phase IIB results, which showed metformin reduced lung inflammation but did not accelerate sputum culture conversion.
The team required the advanced capabilities and expertise of EATRIS through ISIDORe to successfully execute this study. ISIDORe’s advising committee recommended generating a target product profile (TPP) document for metformin to outline its desired characteristics, define the development strategy, design a pivotal Phase III clinical trial protocol, and facilitate dialogue with regulatory authorities.
The committee suggested a double-blind placebo-controlled study with key efficacy endpoints deemed clinically relevant, particularly focusing on the closure of lung cavities. This approach has enabled the team to set up a global trial involving both metformin and N-acetylcysteine (NAC).
The planned trial is a multicentric, global, prospective, parallel-arm, open-label randomized controlled clinical trial. It aims to determine the efficacy of adjuvant treatment with NAC and metformin, alongside anti-TB drugs, in reducing lung function impairment one year post-successful treatment in newly diagnosed sputum-positive drug-sensitive PTB patients.
By following ISIDORe’s expert advice, the trial will contribute to the development of novel treatments for post-TB lung sequelae, ultimately improving patient outcomes worldwide.