J&J: Sirturo significantly improved treatment outcomes in patients with rifampicin-resistant tuberculosis.

1. 83% of participants on an oral Sirturo-containing regimen achieved a favorable outcome compared to 71% of patients on the control regimen.
2. Rates of adverse events were more frequent in the control group compared to the Sirturo-containing regimen group.

The Latest

In the international STREAM Stage 2 phase 3 non-inferiority study, 588 patients over the age of 15 with rifampicin-resistant TB were randomized to either a standard 9 months of treatment (control) or a 6-9-month treatment with a Sirturo-containing drug regimen. While 71% of patients on the control regimen achieved a favorable clinical outcome, 83% of participants on the oral Sirturo-containing regimen achieved favorable outcomes. Treatment changes and extensions due to adverse events were more frequent in the control group than in the Sirturo-oral regimen group.

Physician’s Perspective

Tuberculosis (TB) is an infection caused by Mycobacterium tuberculosis and remains one of the leading causes of morbidity and mortality worldwide. Rates of rifampicin-resistant tuberculosis (RR-TB) continue to rise and are incredibly challenging to treat. Most current treatment regimens for RR-TB involve a 20-month regimen. However, only 59% of those starting treatment in 2018 completed it successfully. Therefore, shorter durations and more accessible treatment options are still needed.

Molecular Target of Therapy

Sirturo is a diarylquinoline drug that targets a subunit of ATP synthase in Mycobacterium tuberculosis, thereby inhibiting ATP synthesis and leading to bacterial death. Diarylquinolines are specific to bacterial ATP synthase and do not target ATP synthase in human cells.

Company History

Johnson & Johnson first introduced Sirturo in 2012 and gained accelerated approval by the FDA in December 2012 after a positive Phase 2 study. To ensure that Sirturo is more accessible globally to those living with TB, Johnson & Johnson granted the Stop TB Partnership’s Global Drug Facility (GDF), a license that allows the Global Drug Facility (GDF) to procure and supply generic versions of Sirturo for the majority of low- and middle-income countries.

Further reading: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)02078-5/fulltext

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