Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LFF571 · 1 trial · 1 indication
Safety assessments will include vital signs, laboratory tests, electrocardiograms (ECG), pharmacokinetic (PK) samples and adverse events. (Cohorts 1 and 2)
Clinical cure is resolution or improvement of symptoms and signs of C. difficile infection such that additional or alternative antimicrobial therapy or other theraperutic intervention is not needed. In addition, patient must have absence of fever for two consecutive days and \<3 non-lliquid stools per day for two consecutive days
Clinical cure is resolution or improvement of symptoms and signs of C. difficile infection such that additional or alternative antimicrobial therapy or other theraperutic intervention is not needed. In addition, patient must have absence of fever for two consecutive days and \<3 non-lliquid stools per day for two consecutive days.
Safety assessments will include vital signs, laboratory tests, electrocardiograms (ECG), pharmacokinetic (PK) samples and adverse events.
| Arm | Type | Description |
|---|---|---|
| LFF571 (POC) | EXPERIMENTAL | - |
| Vancomycin (POC) | ACTIVE_COMPARATOR | - |
| LFF571 Dose level 1 (cohort 2) | EXPERIMENTAL | - |
| LFF571 Dose level 2 (cohort 2) | EXPERIMENTAL | - |
| LFF571 Dose level 3 (cohort 2) | EXPERIMENTAL | - |
| LFF571 Dose level 4 (cohort 2) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| LFF571 | DRUG | - |
| Vancomycin (POC) | DRUG | - |
Inclusion Criteria: * Males and females between 18 and 90 years of age, inclusive. * Diagnosed with primary episode or first relapse of moderate C. difficile infection. Received ≤24 hours of therapy effective for C. difficile infection prior to enrollment. Exclusion Criteria: * Severe C. diffici...
LFF571 is an investigational small molecule being developed for the treatment of moderate Clostridium difficile infection, a bacterial infection that causes diarrhea and colitis. It is administered orally and is currently in clinical development, having completed a Phase 2 trial.
LFF571 is a small molecule antibiotic that targets the bacterial protein synthesis machinery. It binds to the elongation factor Tu, inhibiting protein synthesis in Clostridium difficile bacteria, thereby stopping bacterial growth and treating the infection.
LFF571 is being developed by Novartis AG, a multinational pharmaceutical company headquartered in Switzerland. Novartis is publicly traded on the New York Stock Exchange under the ticker symbol NVS.
LFF571 is in Phase 2 of clinical development. It has completed a Phase 2 clinical trial, but it is not yet approved by regulatory authorities. The drug remains investigational and is not available for commercial use.
LFF571 has been studied in one completed Phase 2 clinical trial with the identifier NCT01232595. This trial evaluated the safety and efficacy of multiple daily dosing of oral LFF571 in patients with moderate Clostridium difficile infections, enrolling 109 participants in the United States and Canada.
No, LFF571 is not the same as fidaxomicin. LFF571 is a distinct investigational small molecule developed by Novartis, while fidaxomicin is a marketed antibiotic. LFF571 has a different mechanism of action, targeting elongation factor Tu, and is being studied specifically for moderate Clostridium difficile infection.