InflaRx (NASDAQ:IFRX) has announced the third phase of Phase II/III study with IFX-1 in severe coronavirus induced pneumonia. The company initiated the first enrolment in a clinical site in the Netherlands.
InflaRx receives approval for Phase III study in Germany
In connection with the commencement of the trial, the German regulatory authority, the Paul-Ehrlich-Institut (PEI), has approved the commencement of the Phase III clinical study in Germany. The double-blind, randomized, and placebo-controlled third phase part of Phase II/II study will enroll around 360 intubated, severely ill COVID-19 induced pneumonia in sites in the EU, US, and South America well as other regions. The study will randomize patients 1:1 who receive IFX-1 or placebo with all patients also receiving standard care.
The trial’s primary endpoint is 28-day all-cause mortality with key secondary endpoints, including evaluating disease improvement and organ support. The company plans an interim analysis after the first 180 patients’ enrollment with the possibility of a preliminary stop for futility or efficacy.
Phase II data published in The Lancet Rheumatology Journal
InflaRX’s R&D Global Head Korinna Pilz said that they were encouraged by the initial second phase results, and now they are rolling out the global Phase III part of the study. Pilz stated that the InflaRx is driven by the possibility of adding to international efforts in the fight against COVID-19 through the advancement of the development of a possible therapy to the severely sick COVID-19 patients. Phase II part data of the trial that assessed IFX-1 in combination with supportive care and as best supportive care in 30 patients will be published in The Lancet Rheumatology peer-reviewed Journal.
The study’s principal investigator Dr. Alexander Vlaar stated that they were delighted that a reputable peer-reviewed journal has recognized the significance of Phase II data in the treatment of critically ill COVID-19 induced pneumonia patients. Vlaar said that preliminary results show promising efficacy signs that include lower organ dysfunction and mortality rates.