Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Ridinilazole
SMT19969 · 3 trials · 2 indications
This primary outcome measures the number of participants with Sustained Clinical Response (SCR). SCR is defined as Clinical Response and no recurrence of CDI through 30 days post End of Treatment (EOT). At D40, D70 and D100 the Investigator or medically qualified designee will determine if the patient has a sustained clinical response or experienced RECURRENCE since the previous assessment. The Investigator will assess cure/failure and recurrence based on available information which includes, but is not limited to, improvement from baseline in the number of UBMs, signs \& symptoms of CDI, and the requirement for CDI medication. The Investigator should assess cure/failure in a way that best reflects the Investigator's standard clinical practice.
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 |
|---|---|---|
| ridinilazole | EXPERIMENTAL | ridinilazole 200mg bid |
| vancomycin | ACTIVE_COMPARATOR | vancomycin 125 mg qid |
| Ridinilazole (SMT19969) | EXPERIMENTAL | 200 mg capsule of Ridinilazole (SMT19969) twice a day for 10 days |
| Fidaxomicin | ACTIVE_COMPARATOR | 200 mg tablet of Fidaxomicin twice a day for 10 days |
| SMT19969 | EXPERIMENTAL | 200 mg capsule of SMT19969 twice a day for 10 days with alternating 200 mg placebo twice a day |
| Name | Type | Description |
|---|---|---|
| Ridinilazole | DRUG | ridinilazole (200 mg bid) |
| Vancomycin | DRUG | vancomycin (125 mg qid) |
| Fidaxomicin | DRUG | - |
| SMT19969 | DRUG | - |
Inclusion Criteria Patients are eligible to be included in the study only if all the following criteria apply: 1. Patient must be at least 18 years of age, at the time of signing the informed consent. 2. Have signs and symptoms of CDI including diarrhea such that in the Investigator's opinion, CDI...
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.