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Also known as Pseudomonas Aeruginosa, IC43 Pseudomonas Aeruginosa
IC43 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| IC43 100 mcg | ACTIVE_COMPARATOR | IC43 100 mcg intramuscular injection, IC43 is a recombinant Pseudomonas aeruginosa fusion protein |
| Placebo | PLACEBO_COMPARATOR | phosphate buffered saline solution containing 0,9 % NaCL |
| IC43 200 mcg | ACTIVE_COMPARATOR | IC43 200 mcg with Aluminum hydroxide |
| IC43 100 mcg w/o | ACTIVE_COMPARATOR | IC43 100 mcg without Aluminum hydroxide |
| Name | Type | Description |
|---|---|---|
| IC43 | BIOLOGICAL | 100 mcg |
| Placebo | DRUG | phosphate buffered saline (PBS) solution containing 0,9 % NaCl |
Inclusion Criteria: * male or female patients admitted to an intensive care unit (ICU) with need for mechanical ventilation for at least 48 hours, aged between 18 and 80 years at Visit 0 * written informed consent or waiver according to the national regulations * no childbearing potential or negati...
IC43 is being developed for the prevention of Pseudomonas aeruginosa infections, including ventilator-associated pneumonia, in intensive care patients. It is a monoclonal antibody candidate from Valneva SE. The program has completed Phase 2 testing in adults aged 18 and older, including patients requiring mechanical ventilation.
IC43 is developed by Valneva SE, a biopharmaceutical company listed under the ticker VALN. Valneva has sponsored the clinical development of IC43, including a completed Phase 2/3 study in Pseudomonas aeruginosa infection and a Phase 2 study in intensive care patients with ventilator-associated pneumonia.
IC43 is in Phase 2 development. Two completed Phase 2 trials have evaluated the candidate: a Phase 2/3 study in Pseudomonas aeruginosa infection and a Phase 2 study in intensive care patients with ventilator-associated pneumonia. No active trials are currently listed, and IC43 is investigational rather than approved.
IC43 has been studied in two completed trials. NCT01563263 was a confirmatory Phase 2/3 study assessing efficacy, immunogenicity, and safety in 803 patients with Pseudomonas aeruginosa infection across Austria, Belgium, Czechia, Germany, Hungary, and Spain. NCT00876252 assessed immunogenicity and safety in 400 intensive care patients with ventilator-associated pneumonia in Austria.
IC43 is a monoclonal antibody candidate designed to target Pseudomonas aeruginosa, the bacterium responsible for the infections studied in its clinical program. By binding to the pathogen, it is intended to support the immune response against Pseudomonas aeruginosa in intensive care patients, including those with ventilator-associated pneumonia.