Clinical Trials

Date: 2016-06-07

Type of information: Treatment of the first patient

phase: 2

Announcement:

Company: InflaRx (Germany)

Product: IFX-1

Action mechanism:

monoclonal antibody. 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, 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 currently being developed in four different indications.

Disease: patients undergoing complex cardiac surgery

Therapeutic area: Cardiovascular diseases

Country: Germany

Trial details:

The “CARDIAC” trial is a four-arm, prospective, randomized, double blind, placebo-controlled multicenter study that will enroll 100 patients in 10 centers across Germany. The patients must undergo a complex cardiac surgery defined as “invasive open heart” and / or “aortic trunk surgical procedures” requiring the use of a heart-lung-machine, otherwise known as cardiopulmonary bypass (CPB).
The reduction of interleukin (IL)-6 levels, as one of the key inflammatory markers, is the primary endpoint. Secondary endpoints include clinical efficacy, safety, and pharmacokinetic parameters.(NCT02866825)

Latest news:

• On June 7th 2016, InflaRx announced that the first patient has been dosed preventively in a phase II clinical trial of IFX-1, a first-in-class monoclonal anti- complement C5a antibody, in patients undergoing complex cardiac surgery. The aim is to evaluate whether the prophylactic treatment with IFX-1 protects patients from severe systemic inflammation and subsequent organ dysfunction. After the recent successful completion of the first phase IIa SCIENS trial, this is the second indication in which IFX-1 is being tested in a phase II clinical trial. IFX-1 has demonstrated an exceptional ability to specifically bind and completely block free complement C5a.