Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ridinilazole · 2 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.
| 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 |
| Name | Type | Description |
|---|---|---|
| Ridinilazole | DRUG | ridinilazole (200 mg bid) |
| Vancomycin | DRUG | vancomycin (125 mg qid) |
| Fidaxomicin | 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...
Ridinilazole is an investigational small molecule being developed for the treatment of Clostridium Difficile Infection, also known as Clostridioides Difficile Infection. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Ridinilazole is a small molecule antibiotic that targets Clostridium Difficile, the bacterium responsible for Clostridioides Difficile Infection. It is designed to treat this infection, which is a significant cause of antibiotic-associated diarrhea.
Ridinilazole is being developed by Summit Therapeutics Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol SMMT. The company is conducting clinical trials to evaluate the drug's safety and efficacy for treating Clostridioides Difficile Infection.
Ridinilazole is currently in Phase 3 clinical development. It has completed a Phase 3 trial (NCT03595553) comparing it to vancomycin for the treatment of Clostridioides Difficile Infection, and a Phase 2 trial (NCT02784002) comparing it to fidaxomicin.
Ridinilazole has completed two clinical trials. The Phase 2 trial NCT02784002 compared it with fidaxomicin in 27 patients with Clostridium Difficile Infection. The Phase 3 trial NCT03595553 compared it with vancomycin in 759 patients with Clostridioides Difficile Infection across multiple countries.
Yes, Ridinilazole is also known as SMT19969. The Phase 2 clinical trial NCT02784002, which studied the drug for Clostridium Difficile Infection, explicitly refers to Ridinilazole as SMT19969 in its official title.