IFRX stock rose on October 19, 2021, after the company announced that it received a $50.7 million grant from the German government.
InflaRx awarded up to $50.7M grant by German Government
InflaRx announced that the German Ministry of Education and Research and the German Ministry of Health have notified InflaRx that the Company has been awarded a grant of up to $50.7M to support the development of vilobelimab for the treatment of severely ill, mechanically ventilated COVID-19 patients.
The grant was awarded as part of a government initiative, which the German Federal Government announced earlier this year, to accelerate the development of promising therapeutic options for the treatment of COVID-19 in patients at all stages of disease.
“We are pleased to receive this significant grant from the German Federal Government, which has recognized the need to invest in the late-stage development of new and promising therapies to treat patients with COVID-19. The emergence of new virus variants and COVID-19 outbreaks in unvaccinated populations worldwide are still leading to a significant number of hospitalizations, highlighting the ongoing need for efficacious treatment options,” commented Thomas Taapken, CFO of InflaRx.
“The funding will enable us to speed up certain vilobelimab development activities and initiate several work streams in parallel, including transfer of the manufacturing process to a site in Germany. We believe this will allow us to reduce the time to a potential drug approval, provided positive clinical results are shown in our ongoing Phase III study.” The purpose of the grant is to advance clinical development activities in COVID-19 and to secure manufacturing capacity for vilobelimab in Germany.
The initial tranche amounts to approximately $29.9M and is structured as reimbursement of 80% of certain pre-specified expenses related to the clinical development and manufacturing of vilobelimab. The remainder of the grant will be awarded in three additional subsequent tranches, each conditional on reaching agreed-upon development and manufacturing-related milestones for the preceding tranche and structured as reimbursement for Company expenses. Individual tranches will not be paid if the preceding milestone of a tranche is not met. Payments from this grant to the Company are expected to begin in Q4 2021. The Phase III part of the Phase II/III study with vilobelimab in critically ill, mechanically ventilated COVID-19 patients has been fully enrolled and treatment is ongoing across sites in the EU, South America and other regions worldwide. Top-line results from this study are expected in Q1 2022.
InflaRx (Nasdaq: IFRX) is a clinical-stage biopharmaceutical company focused on applying its proprietary anti-C5a technology to discover and develop first-in-class, potent and specific inhibitors of C5a. Complement C5a is a powerful inflammatory mediator involved in the progression of a wide variety of autoimmune and other inflammatory diseases. InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA.
InflaRx Completes Enrollment of Vilobelimab Phase III Study in Severe COVID-19
On October 12, 2021, InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced the completion of enrollment of the Phase III part of the Phase II/III vilobelimab study in severe COVID-19 patients.
The randomized, double-blind and placebo-controlled Phase III part of the Phase II/III study enrolled 369 mechanically ventilated patients with COVID-19 across sites in the EU, South America and other regions. Patients were randomized 1:1 to receive either vilobelimab or placebo; all patients received standard of care. The primary endpoint is 28-day all-cause mortality; key secondary endpoints include assessment of organ support and disease improvement. Treatment is still ongoing and topline results are expected to be available in Q1 2022.
Dr. Korinna Pilz, Chief Clinical Development Officer, said: “There remains an urgent need for treatments for critically ill patients with severe COVID-19, and we are pleased that enrollment has completed in this trial. Based on our current expectations regarding when we will be able to lock the database and complete the data analyses, we expect to report topline results in Q1 2022. We are hopeful that vilobelimab can make a meaningful difference for COVID-19 patients. Should the data so warrant, we would then discuss with regulatory authorities the next steps.”
The Phase II part of the study evaluated vilobelimab treatment plus best supportive care compared to best supportive care alone for up to 28 days. The Phase II part was randomized, open label and enrolled a total of 30 patients. The 28-day all-cause mortality rate was 13% (n = 2 of 15) in the vilobelimab treatment arm compared to 27% (n = 4 of 15) in the best supportive care arm. All deaths in the best supportive care arm occurred due to COVID-19-induced multi-organ failure. In the vilobelimab treatment arm, fewer patients experienced renal impairment assessed by estimated glomerular filtration rates compared to best supportive care alone, and more patients showed reversal of blood lymphocytopenia and a greater lowering of lactate dehydrogenase concentrations, a sign of reduction in tissue damage. A temporary, but statistically significant, increase in D-dimer levels in the first days following vilobelimab administration was noted, a potential signal for induction of blood clot lysis. No statistically significant group differences in the primary endpoint of relative change (%) from baseline to day 5 in oxygenation index (defined as PaO2/FiO2 ratio) were detected.
IFRX Stock Technical Analysis
The technical rating of IFRX is bad and it also does not present a quality setup at the moment. Price movement has been a little bit too volatile to find a nice entry and exit point. It is probably a good idea to wait for a consolidation. Click HERE to read the full technical analysis and to get an email alert when the stock has a good setup.