Janssen Research & Development has partnered with the International Union Against Tuberculosis and Lung Disease (The Union) to include Sirturo (bedaquiline) in the Stream study.
The Stream study is an ongoing, multi-centre international randomised controlled study to assess a standardised treatment regimen of anti-tuberculosis drugs for patients with multidrug-resistant tuberculosis (MDR-TB).
Bedaquiline is a diarylquinoline antimycobacterial drug, indicated as part of a combination therapy in adults with pulmonary MDR-TB.
Janssen noted it is working with The Union and the trial’s principal investigators from the UK Medical Research Council (MRC) on an amendment to their current protocol and to evaluate a new treatment regimen, including an all-oral option.
The amendment, including two bedaquiline-containing treatment arms, will be known as Stream 2. It is part of the post-approval requirements for bedaquiline from both US Food and Drug Administration (FDA) and European Medicines Agency (EMA), and is accepted as an alternative to the initially planned Phase III trial of Sirturo.
Sirturo received accelerated approval in the US, conditional approval in the European Union, in addition to approval in South Korea, South Africa and the Philippines.
It is registered in the Russian Federation through a partner for the Russian Federation and Commonwealth of Independent States (CIS), JSC Pharmstandard.
The company filed regulatory applications in China, Colombia, India, Peru, Thailand and Vietnam.
Image: Photomicrograph of a sputum sample containing Mycobacterium tuberculosis. Photo: courtesy of CDC/ TimVickers/ Bawolff.