Modeling and Analysis to support early decision-making and regulatory submission for a TB antibiotic
According to the WHO, TB kills 1.6 million people a year, about 500,000 of whom suffer from extensively drug-resistant strains (XDR-TB). The standard of care for patients with XDR-TB can include a combination of 8 drugs for 18+ months. But the drugs can have serious side-effects, such as deafness, and up to 2/3 patients with XDR TB don’t survive.
The TB Alliance needed to characterize the dose- exposure-response relationship for pretomanid, an investigational TB antibiotic. Certara provided pharmacometrics expertise to facilitate programmatic decision-making and support the regulatory submission by utilizing popPK, PK/PD, and QTc modeling and analysis to inform dose/regimen selection and justification.
Using this information, a clinical trial was conducted for patients with XDR TB and treatment-intolerant or nonresponsive multidrug-resistant (TI/NR-MDR) TB. Approximately 90% of patients receiving this newly-approved regimen recovered after six months of treatment—almost 3X the success rate of prior treatment options. This groundbreaking work also resulted in the award of a tropical disease priority review voucher and sets the stage for a new approach to creating the next-generation of antibiotics for neglected diseases like TB.
The TB Alliance was the first not-for-profit organization to both develop and register an antibiotic. In 2019, the FDA approved pretomanid, only the third new drug for TB in almost 50 years.
TB Alliance is a not-for-profit organization dedicated to the discovery, development and delivery of better, faster-acting and affordable tuberculosis drugs that are available to those who need them.