Jena, Germany – InflaRx, a biopharmaceutical company developing new therapeutics in the terminal complement space, announced positive resultstoday from its SCIENS phase II‑a clinical trial of IFX‑1, a first-in-class monoclonal anti-C5a antibody. The trial reached all primary endpoints and demonstrated safety, tolerability and biological proof of concept of IFX‑1 in patients suffering from early septic organ dysfunction.
IFX‑1 is highly statistically-significant in reducing and effectively blocking C5a in a dose-dependent manner. In addition, the data showed positive trends in several other clinically relevant efficacy endpoints, such as organ dysfunction score (SOFA score), need for ventilator support and length of stay on the ICU. IFX‑1 is the first monoclonal anti-C5a antibody introduced into clinical development, which has now successfully completed a clinical phase II study in patients.
Prof. Niels Riedemann, co-founder and CEO of InflaRx commented, “After 15 years of focused research and development around C5a, one of the most promising targets in inflammation, we are excited that we can now demonstrate the power of our technology in patients. We developed IFX‑1 to become a game-changer in the intensive care field and these new results bring us a big step closer to this goal.”
The SCIENS trial enrolled 72 patients suffering from early septic organ dysfunction in a placebo–controlled, double-blinded dose escalation design and was conducted within the SepNet study trial group in 15 German ICUs (intensive care units). The study investigated the pharmacokinetics/pharmacodynamics (PK/PD), safety and tolerability of IFX‑1 as well as various exploratory secondary clinical endpoints. Furthermore, it represented a first-in-class clinical trial in the infectious acute care space, as it enrolled focus-selected patients suffering from early organ dysfunction within only 3.5 hours of screening to evaluate the benefits of an early Intervention.
“We designed this study to gain in-depth knowledge about IFX‑1 consumption and complement activation in this patient population. We will use the upcoming weeks to carefully analyze all data in order to tailor the planned phase II‑b trial in this vital area of unmet medical need,” noted Dr. Othmar Zenker, Head of Clinical R&D at InflaRx.
“InflaRx has taken a highly innovative clinical trial approach in investigating this very promising antibody to tackle one of the most life-threatening events within the entire acute care field: inflammation-induced organ failure. Based on these encouraging results, we are optimistic that the further development of IFX‑1 could be of significant benefit to patients with this devastating condition and their doctors, where thus far no therapy is available,” concluded Prof. Michael Bauer, who serves as study PI, Chairman of Anesthesiology and Intensive Care Medicine and Chairman of the Center for Sepsis Control and Care at Jena University Hospital.
About septic organ dysfunction and complement C5a:
In serious infections, the body’s immune system activates inflammatory response mechanisms which have been described as the cause of self-induced tissue and organ damage, such as oxygen radical formation and enzyme and cytokine release by activated blood cells. This damage quickly leads to organ dysfunction and, ultimately, organ failure, which is the lead cause of death of patients in most ICUs worldwide. Similar mechanisms have been described in other infectious diseases, such as malaria and dengue fever, as well as in non-infectious inflammation, such as large operations, burns or trauma. Several international scientific groups and the founders of InflaRx have identified C5a as a key “amplifying factor” of most acute inflammatory responses. In experimental models, early blockade of C5a resulted in the preservation of organ function and improved survival by down-regulation of the immune cell-induced tissue damage and various other inflammatory responses.
IFX‑1 is a first-in-class, monoclonal, anti-human complement C5a antibody which demonstrates a complete biological blocking activity and selectivity towards its target, C5a, leaving the important defense mechanism of C5b‑9 formation intact. IFX‑1 is thought to control the inflammatory response-driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response. IFX‑1 is currently in clinical phase II development for several different acute and life-threatening inflammatory indications.
InflaRx is a biopharmaceutical company focusing on the development of new therapeutics to control the body’s inflammatory response, based on its proprietary technology. InflaRx has developed a pipeline of first-in-class antibodies directed against the terminal complement component C5a. While IFX‑1 focuses on the acute care space, its product candidates, IFX‑2 and IFX‑3, are being developed in chronic inflammatory disease indications. InflaRx was founded in 2007 and is headquartered in Jena, Germany, with long-standing research collaborations in the US and China. The team consists of renowned experts in complement research and clinical acute care. InflaRx is privately owned and financed by bm‑t beteiligungsmanagement thüringen Gmbh, KfW Banking Group and various international family offices.