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On 20 February 2023 the headline-results from the PanACEA SUDOCU study were presented at the 30th Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle - the largest and most important conference on HIV and related conditions such as tuberculosis.
SUDOCU investigated safety and efficacy of varying doses of sutezolid – a novel compound in development for treatment of drug-resistant tuberculosis. An innovative trial design was implemented to enable the assessment of sutezolid exposure-response relationship. The study was conducted at four sites in Tanzania and South Africa and found that sutezolid added on top of a background regimen (bedaquiline, delamanid, moxifloxacin) was well tolerated over when given over 12 weeks and improved the treatment efficacy modestly. The results will be instrumental for selection of dose in planned up-coming studies including sutezolid and give hope of replacing linezolid to generate a novel regimen with less toxicity but retained efficacy.
Radboudumc is the coordinator of the PanACEA and UNITE4TB consortia, which aim to shorten and simplify treatment of uncomplicated pulmonary TB. The consortia are renowned for their academic drug development efforts, which includes innovative trial designs for development, repurposing and selection of drugs and regimens especially in the clinical phases of drug development.
Researchers involved were Martin Boeree (Lung diseases), Elin Svensson (Pharmacy), Lindsey te Brake (Pharmacy), Simon Koele (Pharmacy) and Rob Aarnoutse (Pharmacy). All drug management and bioanalysis for determination of drug concentrations were conducted at the department of Pharmacy and Radboud Applied Pharmacometrics group performed the key exposure-response analysis underlying the conclusions for dosing regimens to be carried forward.
