Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SMT19969
Ridinilazole · 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...
Ridinilazole is an investigational small molecule being developed for the treatment of Clostridioides difficile infection, also known as Clostridium 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 Clostridioides difficile, the bacterium that causes Clostridium difficile infection. It is designed to treat this infection by acting against the pathogen, though its specific molecular target has not been disclosed.
Ridinilazole is being developed by Summit Therapeutics Inc., a biopharmaceutical company traded on the NASDAQ 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 in Phase 3 clinical development. A Phase 3 trial, NCT03595553, comparing Ridinilazole to vancomycin for Clostridioides difficile infection has been completed, with 759 participants enrolled. The drug remains investigational and is not yet approved.
Ridinilazole has been studied in two completed clinical trials. NCT02784002 was a Phase 2 study comparing Ridinilazole to fidaxomicin for Clostridium difficile infection, enrolling 27 participants. NCT03595553 was a Phase 3 study comparing Ridinilazole to vancomycin for Clostridioides difficile infection, enrolling 759 participants.
Yes, Ridinilazole is also known as SMT19969. The Phase 2 clinical trial NCT02784002, which studied the drug for Clostridium difficile infection, refers to Ridinilazole as SMT19969 in its title, confirming that both names refer to the same investigational compound.