Date: 2018-06-28
Type of
information: Clinical trial authorisation
phase: 2
Announcement: clinical trial authorization
Company: InflaRx (Germany)
Product: IFX-1
Action
mechanism:
- monoclonal antibody. IFX-1 is a first-in-class monoclonal anti-complement factor C5a antibody which offers a complete biological blocking activity and high selectivity towards its target, C5a in human blood. Thus, IFX-1 leaves the formation of the membrane attack complex (C5b-9) intact to work as an important defense mechanism, which is not the case for molecules blocking the cleavage of C5. 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 pre-clinical studies. IFX-1 is the first monoclonal anti-C5a antibody introduced into clinical development and has, to date, successfully completed 3 clinical phase II studies. In total, over 150 people have so far been treated with IFX-1 which was well tolerated. IFX-1 is currently being developed for different inflammatory indications.
Disease: ANCA-associated vasculitis (AAV)
Therapeutic
area: Autoimmune diseases - Cardiovascular diseases - Rare diseases
Country:
Trial
details:
Latest
news:
- • On June 28, 2018, InflaRx announced the approval of their Investigational New Drug (IND) application by the FDA. The open IND will allow InflaRx to start their planned phase II study to determine the safety and efficacy of IFX-1, a first-in-class anti-human complement factor C5a antibody, in patients with ANCA-associated vasculitis (AAV).
- The phase II study will enroll approximately 36 patients in approximately 20 sites in the U.S. The main objective of the study is to evaluate the safety and efficacy of two different dose regimens of IFX-1 in comparison with placebo on top of current standard of care.
Is
general: Yes
