In short
CR9114 is an investigational protein-based antibody designed to be given as a nasal spray. It is being studied for its ability to protect against influenza virus infection. One completed Phase 2a trial enrolled 140 healthy adult participants to test whether intranasal CR9114 could reduce the incidence of mild to moderate influenza disease after exposure to an influenza A virus. CR9114 has no marketing authorisation and remains an experimental medicine.
Key points
- CR9114 is a broadly neutralising antibody against influenza viruses, given intranasally as a solution.
- One Phase 2a trial tested CR9114 in 140 healthy adults.
- The trial used a wild-type influenza A H3N2 virus as a challenge to see whether CR9114 could reduce illness.
- The main goal was the incidence of mild to moderate influenza disease, measured with the FLU-PRO Plus patient-reported outcome tool.
- The trial also measured treatment-emergent adverse events and serious adverse events.
- The study is completed, and CR9114 has no marketing authorisation.
What is CR9114?
CR9114 is an investigational, protein-based antibody that targets influenza viruses. It is a broadly neutralising anti-influenza antibody, meaning it is designed to recognise and block many different influenza virus strains. In the product records of the European Union Clinical Trials Information System, CR9114 is listed as a solution for intranasal use, supplied by Leyden Laboratories B.V. It has no marketing authorisation, so it is not an approved medicine and remains experimental.
How does CR9114 work?
CR9114 is a broadly neutralising antibody. Broadly neutralising anti-influenza antibodies bind to parts of the influenza virus that change very little between strains, which allows them to recognise many different influenza viruses. In the Phase 2a trial, CR9114 was given intranasally, meaning it was sprayed into the nose, before participants were exposed to a wild-type influenza A virus. The aim was to see whether the antibody could reduce the chance of developing illness after the virus entered the body. Preclinical and Phase 1 work has also examined the safety, pharmacokinetics, and efficacy of intranasal delivery of CR9114.
Which conditions is CR9114 studied for?
- Influenza virus infection — the completed Phase 2a trial tested whether CR9114 could reduce the incidence of mild to moderate influenza disease after exposure to an influenza A virus.
How is CR9114 given?
CR9114 is formulated as a 50 mg/ml solution for intranasal use, meaning it is delivered as a spray into the nose. In the Phase 2a trial, participants received CR9114 intranasally. A placebo nasal solution with the same concentration was used as a comparison.
What do the clinical trials show?
One completed Phase 2a trial investigated CR9114 in 140 healthy adult participants. The study was interventional and used a controlled design in which participants received either CR9114 or a placebo nasal solution, and were also exposed to a wild-type influenza A virus, specifically A/Belgium/4217/2015 (H3N2).
The primary outcomes were the incidence of mild to moderate influenza disease, measured with the InFLUenza Patient Reported Outcome (FLU-PRO) Plus tool, and the frequency and severity of treatment-emergent adverse events and serious adverse events. The FLU-PRO Plus is a patient-reported questionnaire used to capture influenza symptoms from the participant's perspective.
In addition to this Phase 2a trial, earlier Phase 1 and preclinical studies have been reported, covering the safety, pharmacokinetics, and efficacy of intranasal delivery of CR9114.
What side effects are known?
The Phase 2a trial measured treatment-emergent adverse events and serious adverse events as primary outcomes. Published Phase 1 and preclinical studies have also reported on the safety of intranasal delivery of CR9114. Detailed side-effect profiles from these studies are not summarised in the registry record or the supplementary sources provided here.