Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
lefamulin · 1 trial · 1 indication
ECR was defined as survival with improvement in at least 2 signs and symptoms of CABP (relative to baseline), no worsening of any CABP sign or symptom, and no use of concomitant antibiotics (other than adjunctive linezolid, as allowed by the study protocol) for the treatment of CABP through the ECR assessment.
| Arm | Type | Description |
|---|---|---|
| Lefamulin | EXPERIMENTAL | Intravenous lefamulin with potential step-down to oral lefamulin |
| Moxifloxacin +/- Linezolid | ACTIVE_COMPARATOR | Intravenous moxifloxacin with potential step-down to oral moxifloxacin +/- linezolid |
| Name | Type | Description |
|---|---|---|
| lefamulin | DRUG | antibacterial agent |
| Moxifloxacin | DRUG | antibacterial agent |
| Linezolid | DRUG | antibacterial agent |
Inclusion Criteria: 1. Be male or female at least 18 years of age. 2. Provide written informed consent and be willing and able to adhere to the study-specified procedures and restrictions. 3. Have an acute illness (7 days duration) with at least 3 of the following symptoms consistent with a lower r...
Lefamulin is an investigational small molecule being studied for the treatment of Community Acquired Pneumonia (CAP) in adults. It is currently in Phase 3 clinical development and has not been approved by the FDA. The drug is being evaluated as a potential therapy for this infectious disease indication.
Lefamulin is a small molecule antibiotic that works by inhibiting bacterial protein synthesis. It targets the 50S ribosomal subunit of bacteria, binding to the peptidyl transferase center and preventing the formation of peptide bonds. This mechanism of action is distinct from other antibiotic classes, potentially offering an alternative treatment option for Community Acquired Pneumonia.
Lefamulin is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker symbol YCBD. The company is conducting clinical trials to evaluate the drug's safety and efficacy for the treatment of Community Acquired Pneumonia in adult patients.
Lefamulin is currently in Phase 3 clinical development. It has completed one Phase 3 trial for Community Acquired Pneumonia, with a total enrollment of 551 participants. The drug remains investigational and has not yet received FDA approval, as it is still undergoing clinical evaluation.
Lefamulin has one completed Phase 3 clinical trial registered under NCT02559310, titled 'Study to Compare Lefamulin to Moxifloxacin (With or Without Linezolid) for the Treatment of Adults With Pneumonia.' This randomized, double-blind, active-controlled study enrolled 551 adults with Community Acquired Pneumonia across multiple countries including the United States, Argentina, Brazil, and Russia.
Lefamulin is a distinct antibiotic with a unique mechanism of action compared to other drug classes. It is being studied as a monotherapy and in combination with linezolid in clinical trials, but it is not the same as moxifloxacin or linezolid. Lefamulin targets the bacterial ribosome in a way that differs from fluoroquinolones and oxazolidinones.