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Also known as TMC207 (bedaquiline)
TMC207 · 3 trials · 2 indications
Sputum culture conversion is defined as 2 consecutive negative cultures from sputa collected at least 25 days apart.
The table below shows the median time in days to culture conversion for the modified intent-to-treat (mITT) population up to Week 24. Sputum culture conversion is defined as 2 consecutive sputum cultures negative for multi-drug resistant tuberculosis (MDR-TB) taken at least 25 days apart. Participants who discontinued during the 24-week period were considered non-responders (based on Mycobacteria Growth Indicator Tube \[MGIT\]).
The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment.
The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment.
| Arm | Type | Description |
|---|---|---|
| TMC207 (bedaquiline) + Background Regimen (BR) | EXPERIMENTAL | Participants will receive TMC207 (bedaquiline) 400 milligram (mg) as 4\*100 mg tablets once daily 2 weeks (14 days). From Week 3, participants will receive 200 mg (2 tablets) TMC207 (bedaquiline) 3 times a week up to Week 24 along with background regimen (BR). Based on the discussion with the Pharmaceuticals and Medical Devices Agency (PMDA), the extension of 24-week TMC207 treatment with BR drugs may occur up to Week 48, under certain circumstances, such that many BR drugs which are susceptible at the beginning of the Treatment Phase show resistance during the Treatment Phase. After TMC207 is stopped, the BR will be continued up to 78 weeks after conversion or 102 weeks after day 1 (what happens first). |
| TMC207 | EXPERIMENTAL | TMC207 400mg once daily for 2 weeks then 200mg three times a week for 22 weeks in addition to Background Regimen (BR) for the treatment of multi-drug resistant tuberculosis (MDR-TB). |
| TMC207 Stage 1 | EXPERIMENTAL | TMC207 400mg (4 tablets) once daily for 14 days, 200mg (2 tablets) three times a week for 6 weeks in addition to Background Regimen (BR) for multi-drug resistant tuberculosis (MDR-TB). |
| Placebo Stage 1 | PLACEBO_COMPARATOR | Placebo 4 tablets once daily for 14 days, 2 tablets three times a week for 6 weeks in addition to BR for MDR-TB. |
| TMC207 Stage 2 | EXPERIMENTAL | TMC207 400mg (4 tablets) once daily for 14 days, 200mg (2 tablets) three times a week for 22 weeks in addition to BR for MDR-TB. |
| Placebo Stage 2 | PLACEBO_COMPARATOR | Placebo 4 tablets once daily for 14 days, 2 tablets three times a week for 22 weeks in addition to BR for MDR-TB. |
| Name | Type | Description |
|---|---|---|
| TMC207 (bedaquiline) | DRUG | TMC207 (bedaquiline): Participants will receive TMC207 (bedaquiline) 400 milligram (mg) as 4\*100 mg tablets once daily 2 weeks (14 days) followed by 200 mg (2 tablets) 3 times a week up to Week 24 along with background regimen (BR). Based on the discussion with the Pharmaceuticals and Medical Devices Agency (PMDA), the extension of 24-week TMC207 treatment with BR drugs may occur up to Week 48, under certain circumstances, such that many BR drugs which are susceptible at the beginning of the Treatment Phase show resistance during the Treatment Phase. |
| Background Regimen (BR) | DRUG | Participants will receive anti-bacterial tuberculosis drugs (pyrazinamide \[PZA\], ethambutol \[EB, EMB\], streptomycin \[SM\], kanamycin \[KM, KAN\], enviomycin \[EVM\], ethionamide \[TH\], cycloserine \[CS\], para-aminosalicylic acid \[PAS\], amikacin \[AMK\], levofloxacin \[LVFX\] and other fluoroquinolone. Other drugs are used less commonly, such as amoxicillin-clavulanate, linezolid and clofazimine based on Investigator's decision twice a week from Day 1 up to 78 weeks after conversion or 102 weeks after day 1 (what happens first). |
| TMC207 | DRUG | TMC207 400mg once daily for 2 weeks then 200mg three times a week for 22 weeks. |
| Background Regimen (BR) for MDR-TB | DRUG | Background Regimen (BR) of antibacterial drugs used in the treatment of TB according to national TB program and selected at the baseline visit as specified in the protocol for up to 96 weeks. |
| Placebo | DRUG | Placebo 4 tablets once daily for 14 days, 2 tablets three times a week for 6 or 22 weeks. |
| Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis) | DRUG | Background Regimen (BR) of antibacterial drugs used in the treatment of TB according to national TB program and selected at the baseline visit as speciified in the protocol for up to 96 weeks. |
Inclusion Criteria: * Must have confirmed pulmonary multi-drug resistant tuberculosis (MDR-TB) infection, which is defined as infection by a strain of M. tuberculosis resistant to both rifampicin and isoniazid (RFP and INH) by previous screening from a TB treatment * Must have confirmed positive re...
Top 2 of 3 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT164a1, BNT164b1 |
| GSK plc Sponsored ADR | GSK | 1 | PHASE1 | Ganfeborole |
TMC207 is used for tuberculosis, specifically multidrug-resistant tuberculosis (MDR-TB). It is studied as part of an individualized MDR-TB treatment regimen in participants with sputum smear-positive pulmonary MDR-TB. It is a small molecule in the infectious disease therapeutic area.
TMC207 is developed by Johnson & Johnson, which trades under the ticker JNJ. The company has sponsored Phase 2 clinical trials of the drug in multiple countries, including Japan, China, South Africa, Peru, and Russia.
TMC207 is in Phase 2 clinical development. It is investigational and has not been approved. Two Phase 2 trials are completed, and no active trials are ongoing. The completed trials enrolled a total of 449 participants across both studies.
TMC207 has been studied in Phase 2 trials including NCT02365623, an exploratory study in Japanese participants with pulmonary MDR-TB, and NCT00910871, which evaluated safety, tolerability, and efficacy as part of an individualized MDR-TB treatment regimen. Both trials are completed.
Yes, TMC207 is also known as bedaquiline. TMC207 (bedaquiline) is the same compound, so readers searching either name are looking at the same drug asset developed by Johnson & Johnson for multidrug-resistant tuberculosis.
TMC207 was studied in randomized, double-blind, placebo-controlled Phase 2 trials. NCT00910871 enrolled 241 participants with sputum smear-positive pulmonary MDR-TB, and NCT00449644 enrolled 208 participants with multidrug-resistant Mycobacterium tuberculosis. Both trials are completed.