Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IFX-1+ BSC · 1 trial · 1 indication
Relative change (%) from baseline in Oxygenation Index (OI; partial pressure of oxygen in the arterial blood (PaO2) / fractional inspired oxygen (FiO2)) in supine position for ≥2 hours at day 5 (FAS)
Number and percentage of deaths (all-cause) until Day 28 (FAS)
| Arm | Type | Description |
|---|---|---|
| Phase II: IFX-1 + BSC | EXPERIMENTAL | Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care |
| Phase II: BSC | OTHER | Phase II study part: BSC: Best supportive care |
| Phase III: IFX-1 + SOC | EXPERIMENTAL | Phase III study part: IFX-1: 800mg intravenously administered, SOC: Standard of care |
| Phase III: Placebo + SOC | PLACEBO_COMPARATOR | Phase III study part: Placebo: placebo infusion intravenously administered, SOC: Standard of care |
| Name | Type | Description |
|---|---|---|
| IFX-1 + BSC | DRUG | Phase II study part: IFX-1 + BSC |
| BSC | DRUG | Phase II study part: BSC |
| IFX-1 + SOC | DRUG | Phase III study part: IFX-1 + SOC |
| Placebo + SOC | DRUG | Phase III study part: Placebo + SOC |
Phase II Inclusion Criteria: * At least 18 years of age or older * Clinically evident or otherwise confirmed severe pneumonia * SARS-CoV-2 infection confirmation (tested positive in last 14 days before randomization with locally available test system) Exclusion Criteria: * Known history of progr...
IFX-1 is an investigational small molecule being studied for hidradenitis suppurativa, granulomatosis with polyangiitis, severe COVID-19 pneumonia, and systemic inflammatory response syndrome. It is in Phase 2 clinical development and is not approved by the FDA.
IFX-1 is being developed by InflaRx N.V., a biopharmaceutical company traded on the NASDAQ under the ticker IFRX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in several inflammatory and autoimmune conditions.
IFX-1 is in Phase 2 clinical development. All four clinical trials listed for the drug are Phase 2 studies and have been completed. The drug remains investigational and has not received regulatory approval for any indication.
IFX-1 has completed four Phase 2 trials: NCT02866825 in systemic inflammatory response syndrome, NCT03487276 in hidradenitis suppurativa, NCT03895801 in granulomatosis with polyangiitis, and NCT04333420 in severe COVID-19 pneumonia. These trials enrolled a total of 399 participants.
IFX-1 is a small molecule that targets the complement system, specifically the C5a receptor, to modulate inflammatory responses. By blocking this receptor, the drug aims to reduce the excessive inflammation seen in conditions like hidradenitis suppurativa and COVID-19 pneumonia.