Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Viatris, Inc. | VTRS | 1 | PHASE3 | Bedaquiline |
| Johnson & Johnson | JNJ | 1 | PHASE2 | Bedaquiline, Background Regimen |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT164a1, BNT164b1 |
TMC207 is an investigational small molecule being developed for the treatment of tuberculosis, including multidrug-resistant tuberculosis (MDR-TB). It is studied in patients with pulmonary MDR-TB as part of combination therapy. As of the available data, TMC207 is in Phase 2 clinical development and is not yet approved.
TMC207 targets mycobacterial ATP synthase, an enzyme essential for energy production in Mycobacterium tuberculosis. By inhibiting this enzyme, TMC207 disrupts bacterial energy metabolism, leading to bacterial cell death. This mechanism is distinct from many existing TB drugs, making it potentially effective against drug-resistant strains.
TMC207 is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with tuberculosis, including multidrug-resistant forms.
TMC207 is in Phase 2 clinical development. All three completed trials listed for TMC207 are Phase 2 studies. These trials have been completed, and the drug remains investigational, meaning it has not yet received regulatory approval for any indication.
TMC207 has been studied in three completed Phase 2 trials. NCT00449644 enrolled 208 participants with MDR-TB across multiple countries. NCT00910871 enrolled 241 participants with sputum smear-positive pulmonary MDR-TB. NCT02365623 was an exploratory study in 6 Japanese participants with pulmonary MDR-TB.
TMC207 is also known as bedaquiline, a drug approved for the treatment of multidrug-resistant tuberculosis. In clinical trials, TMC207 was the investigational name used during development. The drug is now marketed under the brand name Sirturo by Johnson & Johnson.