Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RIFAFOUR e-275 · 1 trial · 1 indication
The EBA CFU(0-14) as determined by the rate of change in logCFU per ml sputum over the period Day 0 to Day 14 which will be described with at most 3 parameters from a linear, bi-linear or non-linear regression of logCFU on time
| Arm | Type | Description |
|---|---|---|
| Meropenem;amoxycillin/clavulanic acid | EXPERIMENTAL | Meropenem 2g will be administered intravenously 8-hourly; plus amoxycillin/CA 500mg/125mg will be administered orally 8-hourly for 14 days |
| Faropenem; amoxycillin/CA | EXPERIMENTAL | Faropenem 600mg will be administered orally 8-hourly; plus amoxycillin/CA 500mg/125mg will be administered orally 8-hourly for 14 days |
| Rifafour e-275 | ACTIVE_COMPARATOR | Rifafour e-275 will be administered orally once daily for 14 days as per South African National TB Treatment Guidelines |
| Name | Type | Description |
|---|---|---|
| Meropenem | DRUG | To administer 2g daily 8 hourly for 14 days |
| Faropenem | DRUG | To adminster 600mg 8 hourly daily for 14 days |
| Amoxycillin/clavulanic acid | DRUG | To administer 625mg 8 hourly daily for 14 days together with the faropenem and meropenem |
| Rifafour e275 | DRUG | To be taken as per the National TB treatment programme for 14 days |
Inclusion Criteria: 1. Provide written, informed consent prior to all trial-related procedures including HIV testing. 2. Male or female, aged between 18 and 65 years, inclusive. 3. Body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive. 4. Newly diagnosed, previously untr...
RIFAFOUR e-275 is an investigational small molecule therapeutic being developed by GSK plc for pulmonary tuberculosis. It is in Phase 2 clinical development and has been studied in a single completed trial. It is not described as approved, and it remains under clinical investigation for infectious disease.
RIFAFOUR e-275 is being developed for the treatment of pulmonary tuberculosis, an infectious disease. Its clinical evaluation has focused on adult patients with newly diagnosed pulmonary tuberculosis. The drug is investigational and has not been established as an approved therapy.
RIFAFOUR e-275 is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating the drug in pulmonary tuberculosis. The asset is an investigational small molecule in the company's infectious disease pipeline.
RIFAFOUR e-275 is in Phase 2 clinical development. One Phase 2 trial has been completed, and no active trials are ongoing. The program has enrolled 46 participants in total. The drug is investigational and has not been described as approved for any indication.
RIFAFOUR e-275 has been evaluated in the completed Phase 2 trial NCT02349841, titled a Phase 2 trial to evaluate early bactericidal activity, safety and tolerability of meropenem plus amoxycillin/CA and faropenem plus amoxycillin/CA in adults with newly diagnosed pulmonary tuberculosis. The trial enrolled 46 participants in South Africa and was active controlled and randomized.
Yes, RIFAFOUR e-275 is also known as Rifafour e275. The two names refer to the same investigational GSK plc asset in Phase 2 development for pulmonary tuberculosis. Searches using either spelling point to the same drug program and the same completed Phase 2 trial, NCT02349841.