Peptide education
Murepavadin
POL7080
Murepavadin is an investigational peptide-like antibiotic studied against Pseudomonas aeruginosa. Researchers investigated intravenous and inhaled formulations in separate programs.
The intravenous pneumonia trials stopped after a safety review; the sponsor reported more kidney injuries than expected. An inhaled form was studied separately.
Overview
Quick answer
The kidney-safety signal concerns the intravenous pneumonia program. It does not by itself establish the safety or risk of the separately studied inhaled formulation.
Is murepavadin FDA-approved?
Exact openFDA active-ingredient and brand-name searches found no matches for murepavadin or POL7080. Other names and jurisdictions require separate checks.
What did the healthy-volunteer study show?
A small intravenous study measured drug exposure and adverse events in healthy men. It did not test whether the drug cures infection.
Was it studied in people with pneumonia?
Yes. An uncontrolled phase 2 study enrolled 25 people with ventilator-associated pneumonia and gave murepavadin alongside standard care. An investigator abstract reported clinical cure in 10 of 12 patients in the confirmed-infection analysis. Without a comparison group, the result cannot establish added benefit from murepavadin.
Why did the intravenous pneumonia studies stop?
The phase 3 registry lists termination after safety review. The sponsor reported a higher-than-expected frequency of acute kidney injury in the intravenous program.
Is the inhaled formulation the same evidence?
No. The sponsor reported a completed inhaled phase 1 study in 39 healthy volunteers and no serious adverse events in preliminary blinded data. This is not evidence of efficacy or established patient safety.
Is the inhaled cystic fibrosis program still active?
The Cystic Fibrosis Foundation lists its inhaled murepavadin program as discontinued, with no active development in cystic fibrosis. That listing does not establish the program's status in other conditions.
Evidence
Evidence snapshot
Testing against bacterial isolates evaluates susceptibility in the laboratory, not whether patients recover from pneumonia.
The study assessed pharmacokinetics and early safety, not treatment of an infection.
Investigators reported clinical cure in the confirmed-infection analysis. All received standard care alongside murepavadin, and there was no comparison group.
The registry lists 41 participants in PRISM-MDR. The sponsor reported a higher-than-expected frequency of acute kidney injury.
Claims
Common claims vs evidence
| Claim | Human evidence | Mechanistic evidence | Verdict |
|---|---|---|---|
| Laboratory activity proves murepavadin treats resistant infection. | A small uncontrolled patient study reported clinical outcomes with standard care, but cannot isolate the drug's effect. The phase 3 registry does not provide a completed efficacy result. | A laboratory study tested activity against resistant Pseudomonas isolates. A susceptibility result is not a patient outcome. | Clinical benefit is not established by these sources. |
| The kidney signal proves that inhaled murepavadin has the same risk. | The sponsor described the signal during intravenous pneumonia research. A separate inhaled study reported preliminary findings in healthy volunteers, not comparative safety in patients. | The two formulations require separate safety evidence. |
Bottom line
Main takeaway
Murepavadin is an experimental antibiotic and is not an established pneumonia treatment.
A kidney-safety signal stopped the intravenous program; inhaled safety is a separate question.
The termination is in the trial registry; the kidney-injury description is sponsor-reported.
Identity
What it is
Murepavadin, or POL7080, is a cyclic peptidomimetic designed to act against Pseudomonas aeruginosa. It was investigated intravenously for serious lung infections and separately in an inhaled formulation.
Research
Research evidence
The intravenous healthy-volunteer study measured exposure and safety. An uncontrolled phase 2 pneumonia study reported patient outcomes with concurrent standard care, while the later phase 3 trial stopped early. The sponsor reported preliminary findings from a separate inhaled study.
| Study / evidence area | Population | Design | Product context | Main outcome | Limitations | Weight |
|---|---|---|---|---|---|---|
| IV phase 1 | Healthy adult men, including 52 who received murepavadin | Randomized, double-blind, placebo-controlled dose escalation | Single or repeated intravenous infusions | Exposure and adverse events were measured; one repeated-dose participant withdrew after a severe infusion-site reaction. | Not an infection study and too small to exclude uncommon or population-specific harms. | Early human pharmacokinetic and safety evidence |
| IV phase 2 pneumonia study | 25 patients with suspected or documented Pseudomonas ventilator-associated pneumonia | Open-label, uncontrolled, multicenter phase 2 study | Intravenous murepavadin with standard-of-care antibiotics | An investigator conference abstract reported clinical cure at the test-of-cure visit in 10 of 12 patients in the microbiological intention-to-treat analysis. | The confirmed-infection group was small. There was no comparison group, so the outcomes cannot establish murepavadin's added benefit. | Early uncontrolled patient evidence, reported in a conference abstract |
| PRISM-MDR | Adults with suspected or confirmed Pseudomonas ventilator-associated pneumonia | Randomized, open-label phase 3 study stopped early after safety review | Intravenous murepavadin plus another antipseudomonal antibiotic versus two antipseudomonal antibiotics | The sponsor reported higher-than-expected acute kidney injury. The registry lists 41 participants and no posted efficacy results. | The safety statement is sponsor-reported, not a completed comparative analysis. Early termination prevents a confirmatory efficacy conclusion. | Terminated study and sponsor safety report |
| Inhaled phase 1 research | 39 healthy adults | Randomized, double-blind, placebo-controlled single-ascending-dose phase 1 study | Inhaled murepavadin, separate from the IV formulation | The sponsor reported no serious adverse events in preliminary blinded data and described drug exposure in blood and lung fluid. | Sponsor-reported preliminary findings in healthy people do not establish patient efficacy or comparative safety. | Sponsor-reported preliminary human safety and exposure findings |
Use context
Reported use context
The dose below belongs to healthy-volunteer intravenous research. It is not a pneumonia regimen or an inhaled dose.
Study and label context
Single ascending doses ranged from 0.05 to 4.5 mg/kg; most infusions lasted three hours.
Study-reported only, not a recommendation.Cautions
Safety and unknowns
- The sponsor reported a higher-than-expected frequency of acute kidney injury in the intravenous phase 3 program, which was closed after a safety review. The report does not establish the same outcome for the inhaled formulation.
- In the healthy-volunteer study, a participant withdrew after a severe infusion-site reaction. Early tolerability in healthy people cannot rule out harm in critically ill patients.
- In the separate inhaled phase 1 study, the sponsor reported no serious adverse events in preliminary blinded data from healthy volunteers. Those findings do not establish safety in patients or exclude uncommon harms.
Product quality
Product identity and quality
Intravenous and inhaled investigational formulations are not interchangeable. A name on an unrelated product does not verify its identity, concentration, or sterility.
U.S. approval
The exact-name FDA search covered murepavadin and POL7080, not every name or jurisdiction.
Mechanism
How it is proposed to work
Murepavadin targets a bacterial outer-membrane protein called LptD, involved in moving a component of the bacterial surface.
Laboratory activity against Pseudomonas isolates supports research interest, but does not establish a cure rate in people.
FAQ
Common questions
Does activity against Pseudomonas in a laboratory prove it treats pneumonia?
No. Laboratory activity is not evidence of clinical cure, and the intravenous phase 3 program was stopped after a safety review.
Details
Technical details
Sources
References
- 1.
doi:10.1128/AAC.02355-17 PMID:29437621
Intravenous phase 1 pharmacokinetic and safety study in healthy men, not an infection efficacy trial.
- 2.
ClinicalTrials.gov. Pharmacokinetics, safety and efficacy of POL7080 in patients with ventilator-associated Pseudomonas aeruginosa pneumonia
NCT02096328
Completed open-label phase 2 study of intravenous murepavadin with standard care in 25 patients.
- 3.
Critical Care conference abstract P445. Efficacy of murepavadin co-administered with standard-of-care in a phase 2 study in patients with ventilator-associated pneumonia due to Pseudomonas aeruginosa infection
Investigator conference abstract reports clinical cure in a confirmed-infection subset; the study was uncontrolled and used concurrent standard care.
- 4.
ClinicalTrials.gov. Pivotal study in ventilator-associated pneumonia suspected or confirmed to be due to Pseudomonas aeruginosa
NCT03409679
The phase 3 intravenous study was terminated after a safety data review; no results are posted in the registry.
- 5.
Study sponsor. Closure of the intravenous phase 3 PRISM studies
Sponsor-reported higher-than-expected acute kidney injury in the intravenous program; not a published comparative analysis.
- 6.
UK Health Research Authority. Safety, tolerability and pharmacokinetics study of inhaled murepavadin in healthy subjects
Research authority summary describes a separate planned inhaled phase 1 study; it does not report outcomes.
- 7.
Study sponsor. First-in-human study of inhaled murepavadin: sponsor-reported safety and pharmacokinetics
Sponsor reports completion in 39 healthy volunteers and preliminary blinded safety findings, not patient efficacy or a full comparative safety analysis.
- 8.
Cystic Fibrosis Foundation. Inhaled murepavadin cystic fibrosis development pipeline
The foundation lists its cystic fibrosis program as discontinued; this does not establish status in other indications.
- 9.
PubMed. Murepavadin activity tested against contemporary clinical isolates of XDR Pseudomonas aeruginosa
doi:10.1093/jac/dky227 PMID:29901750
Laboratory isolate study and LptD mechanism; in vitro activity is not a clinical cure rate.
- 10.
FDA. Drugs@FDA approved drug products database
Search murepavadin and POL7080 in Drugs@FDA. This link opens the search page, not a saved result.
- 11.
FDA. FDA information about Drugs@FDA coverage
Exact openFDA active-ingredient and brand-name queries for murepavadin and POL7080 found no matches. This page describes database coverage, not the saved results; other names and jurisdictions are not assessed.