InflaRx initiates exploratory phase II trial with IFX-1, a first-in-class anti-complement C5a antibody, in patients with Hidradenitis Suppurativa
Jena, Germany, January 4th 2017 - InflaRx, the biopharmaceutical company developing new therapeutics in the terminal complement space, announced today enrollment of the first patient into a Phase II trial to assess InflaRx’ investigational therapy IFX-1, a first-in-class monoclonal anti-complement C5a antibody, in patients with moderate to severe Hidradenitis Suppurativa (HS).
The objective of the trial is to evaluate the safety, tolerability and pharmacokinetics of chronic treatment with IFX-1. The open label, single center study will enroll twelve patients who failed on previous treatment with antibiotics or other biologicals. Patients will receive one weekly dose of IFX-1 over the course of eight weeks. Additional data on pharmacodynamics and clinical parameters are collected to increase the knowledge of treatment of HS with IFX-1. Key results are expected in the third quarter of 2017.
“We are pleased to start this study and evaluate the potential of IFX-1 in this devastating chronic autoimmune disease. There is growing evidence that a dysregulation of the immune system is involved in the pathogenesis of HS”, Othmar Zenker, Head of Clinical Research and Development of InflaRx, explained. “With IFX-1, we are able to block C5a, one of the key molecules in the innate immune system, promoting neutrophil activation and T-cell dysbalance, which both are believed to be involved in this disease”, he continued.
The principle investigator of the study, Professor Giamarellos-Bourboulis of the National and Kapodistrian University of Athens, added, ”Despite some recent progress, the current treatment options for many patients with HS are still limited. There is a high medical need to develop further compounds with new modes of action. We are eager to study whether blocking C5a can become a therapeutic option for these patients.”
About Hidradenitis Suppurativa: Hidradenitis Suppurativa (HS), also known as acne inversa, is a painful, chronic and debilitating inflammatory skin disease characterized by recurrent abscesses, painful nodules and formation of sinus tracts mainly in the axillary and groin areas. HS causes significant physical and psychosocial distress and can have a considerable impact on patients’ quality of life. HS affects approximately 170,000 people in the USA and more than 200,000 in Europe. Currently anti-TNF alpha monoclonal antibody treatment is the only approved biological treatment for moderate to severe HS in the USA and in Europe.
About IFX-1: IFX-1 is a first-in-class monoclonal anti-complement C5a antibody which offers a complete biological blocking activity and selectivity towards its target, C5a. Thus, IFX-1 leaves the formation of the membrane attack complex (C5b-9) intact to work as an important defense mechanism. IFX-1 has been demonstrated to control the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response in different pre-clinical studies. IFX-1 is the first monoclonal anti-C5a antibody introduced into clinical development and has thus far successfully completed a clinical phase IIa study in patients suffering from septic organ dysfunctions in which all primary endpoints were met. IFX-1 is currently being developed in various chronic and acute inflammatory indications.
About InflaRx: InflaRx is a biopharmaceutical company focusing on the development of new breakthrough therapeutics controlling inflammation resulting from terminal complement activation. It ́s lead drug IFX-1 takes a global lead status in the area of targeted complement C5a inhibition, which the company believes to hold vast potential as a game changer in inflammation. The company also develops additional molecules (IFX-2 and IFX-3) targeting chronic inflammatory and inflammation related diseases. InflaRx was founded in 2007 and is headquartered in Jena, Germany. The team consists of renowned experts in complement and clinical research. InflaRx recently closed its series C financing round bringing in EUR 33M. InflaRx is financed by STS, bm-t Beteiligungsmanagement Thüringen Gmbh, KfW banking group and various international family and industrial investment offices.