In short
N-[2-[(1S)-1-(3-ETHOXY-4-METHOXYPHENYL)-2-(METHANESULFONYL)ETHYL]-3-OXO-2,3-DIHYDRO-1H-ISOINDOL-4-YL]CYCLOPROPANECARBOXAMIDE (also referred to as CC11050) is an investigational substance with no marketing authorisation. It is being studied as a potential host-directed therapy for multidrug-resistant pulmonary tuberculosis. The only registered trial is a completed Phase 2 study involving 330 participants that compared this substance and metformin against a control arm.
Key points
- Investigational substance with no marketing authorisation in the product records
- Studied in multidrug-resistant pulmonary tuberculosis as a host-directed therapy
- One completed Phase 2 trial with 330 participants
- Given as a 400 mg hard gelatin capsule by oral use
- Trial measured lung function recovery and eradication of M. tuberculosis infection at month 6
- Supplied by The Aurum Institute for the clinical study
What is this substance?
N-[2-[(1S)-1-(3-ETHOXY-4-METHOXYPHENYL)-2-(METHANESULFONYL)ETHYL]-3-OXO-2,3-DIHYDRO-1H-ISOINDOL-4-YL]CYCLOPROPANECARBOXAMIDE is an investigational substance with no marketing authorisation in the product records. The substance is also referred to by the development code CC11050 in the trial documentation. It is classified under respiratory tract diseases in the therapeutic area coding of the registry records. The product is supplied by The Aurum Institute for the clinical study. In one product record, the substance is part of a fixed combination.
How does it work?
The clinical trial describes this substance as one of two adjunctive host-directed therapies, specifically an anti-inflammatory agent. Host-directed therapy aims to modify the body's own immune response rather than attacking the tuberculosis bacteria directly. The brief summary states that the trial investigated one anti-inflammatory and one antimicrobial therapy as adjuvants to standard treatment. CC11050 was the anti-inflammatory arm of the study.
Which conditions is it studied for?
- Multidrug-resistant pulmonary tuberculosis — a form of tuberculosis affecting the lungs that does not respond to rifampicin and at least one other first-line drug
The trial condition is recorded as multidrug-resistant pulmonary tuberculosis, also described in the title as rifampin-resistant tuberculosis. The study focuses on patients whose tuberculosis is resistant to rifampicin, one of the main antibiotics used to treat the disease.
How is it given?
The substance is formulated as a hard gelatin capsule for oral use. In the trial, the dose used was 400 mg taken orally. The capsule is swallowed, and the substance is absorbed through the digestive tract.
What do the clinical trials show?
There is one registered clinical trial investigating this substance: a completed Phase 2 randomised controlled trial with 330 participants. The trial compared two adjunctive host-directed therapies — CC11050 and metformin 1500 mg — each against a control arm. The study had two co-primary objectives that both had to be met for a treatment to be considered successful: forced expiratory volume in one second (FEV1) at month 6, a measure of lung function, and the probability of stable sputum culture conversion by month 6, meaning the tuberculosis bacteria could no longer be grown from patient samples. The primary outcome also included measures of lung function recovery and eradication of Mycobacterium tuberculosis infection, with assessment at month 6, where a nominal month is defined as 4 weeks. The trial status is completed, meaning the study has finished collecting data.
Who can take part in these trials?
The trial enrolled 330 participants with multidrug-resistant pulmonary tuberculosis. The participants were patients with pulmonary tuberculosis resistant to rifampicin. As the trial is completed, no new participants are being recruited.