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.