Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SMT19969 · 1 trial · 1 indication
Sustained clinical response is defined as clinical cure at the Test of Cure Visit (Day 12) and no recurrence of CDAD within 30 days of End of Therapy
| Arm | Type | Description |
|---|---|---|
| SMT19969 | EXPERIMENTAL | 200 mg capsule of SMT19969 twice a day for 10 days with alternating 200 mg placebo twice a day |
| Vancomycin | ACTIVE_COMPARATOR | 125 mg capsule four times a day for 10 days |
| Name | Type | Description |
|---|---|---|
| SMT19969 | DRUG | - |
| Vancomycin | DRUG | - |
Inclusion Criteria: * Informed consent * Clinical diagnosis of CDAD plus laboratory diagnostic test * No more than 24 hrs antimicrobial treatment for current CDAD episode * No more than 3 episodes of CDAD in prior 12 months * No previous episode of CDAD within 30 days of study enrollment * Female s...
SMT19969 is an investigational small molecule being developed for the treatment of Clostridium difficile infection, also known as Clostridium difficile-associated diarrhoea. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
SMT19969 is a small molecule antibiotic that targets Clostridium difficile bacteria. It is being studied for its ability to treat Clostridium difficile infection, a condition that causes diarrhoea and inflammation of the colon.
SMT19969 is being developed by Summit Therapeutics Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the safety and efficacy of SMT19969 for the treatment of Clostridium difficile infection.
SMT19969 is in Phase 2 clinical development. A Phase 2 trial has been completed, and the drug remains investigational, meaning it has not yet been approved by the FDA or other regulatory agencies for commercial use.
SMT19969 has been studied in a Phase 2 clinical trial with the identifier NCT02092935. This completed trial compared SMT19969 with vancomycin for the treatment of Clostridium difficile-associated diarrhoea and enrolled 100 participants in the United States and Canada.
SMT19969 is also known as ridinilazole. It is being developed by Summit Therapeutics Inc. for the treatment of Clostridium difficile infection. The drug is currently in Phase 2 clinical development.