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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.[3] 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.[1] It has no marketing authorisation, so it is not an approved medicine and remains experimental.[1]
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.[3] 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.[1] Preclinical and Phase 1 work has also examined the safety, pharmacokinetics, and efficacy of intranasal delivery of CR9114.[2]
CR9114 is formulated as a 50 mg/ml solution for intranasal use, meaning it is delivered as a spray into the nose.[1] In the Phase 2a trial, participants received CR9114 intranasally. A placebo nasal solution with the same concentration was used as a comparison.[1]
One completed Phase 2a trial investigated CR9114 in 140 healthy adult participants.[1] 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).[1]
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.[1] 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.[2]
The Phase 2a trial measured treatment-emergent adverse events and serious adverse events as primary outcomes.[1] Published Phase 1 and preclinical studies have also reported on the safety of intranasal delivery of CR9114.[2] Detailed side-effect profiles from these studies are not summarised in the registry record or the supplementary sources provided here.
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