Date: 2016-01-26
Type of
information: Results
phase: 2
Announcement: results
Company: InflaRx (Germany)
Product: IFX-1
Action
mechanism:
- monoclonal antibody. 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 various different acute and life-threatening inflammatory indications.
Disease: severe sepsis, septic shock
Therapeutic
area: Inflammatory diseases
Country: Germany
Trial
details:
- This phase II randomized, placebo-controlled, double-blind, dose controlled trial enrolls patients with early severe sepsis or septic shock displaying at least one newly developed organ dysfunction and showing clinical evidence of pulmonary or abdominal infection. The primary goal of the trial is to assess the pharmacokinetics and pharmacodynamics of the new monoclonal antibody CaCP29 and to characterize safety and tolerability as well as evaluate parameters of efficacy. (NCT02246595)
Latest
news:
- • On January 28th 2016, InflaRx, a biopharmaceutical company developing new therapeutics in the terminal complement space, announced results from its SCIENS phase IIa clinical trial of IFX-1, a first-in-class monoclonal anti-C5a antibody. IFX-1 highly statistically significantly reduced and effectively blocked C5a in a dose dependent manner. 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. In addition, the data showed positive trends in various 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. 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 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 represents a first-in-class clinical trial in the infectious acute care space, as it enrolled focus-selected patients with early organ dysfunction within only 3.5 hours after screening, to evaluate the benefits of an early intervention. InflaRx will use these data to tailor its planned phase 2b trial.
Is
general: Yes
