Date: 2018-03-08
Type of
information: Recruitment of the first patient
phase: 2b
Announcement: recruitment of the first patient
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: moderate to severe Hidradenitis Suppurativa (HS)
Therapeutic
area: Dermatological diseases - Inflammatory diseases
Country: Bulgaria, Canada, Denmark, France, Germany, Greece, The Netherlands, Poland, USA
Trial
details:
- Hidradenitis suppurativa (HS) is a chronic devastating skin disorder affecting areas rich in apocrine glands. HS is diagnosed by its clinical features and its chronicity. It is recognized by the presence of recurrent, painful, deep-seated, rounded nodules usually ending in abscesses and sinus tracts with suppuration and hypertrophic scarring. As complement C5a is involved in the underlying acute inflammatory responses, this study is set up based on the hypothesis that IFX-1 might be able to block C5a induced pro-inflammatory effects such as neutrophil activation and cytokine generation, potentially contributing to the local skin inflammation and tissue damage.
- The study’s primary goal is to evaluate the dose-response signal of IFX-1 in patients with HS according to the Hidradenitis Suppurativa Clinical Response (HiSCR) at week 16 during the study period. Secondary goals are assessment of further efficacy and patient-reported outcome parameters, as well as the safety and tolerability of IFX-1. After the placebo-controlled double-blind phase, the study will be extended into an open label extension phase to assess long-term efficacy and safety. The study will be coordinated by the principal investigator Prof. Dr. med. Evangelos J. Giamarellos-Bourboulis at the ATTIKON University Hospital in Athens, Greece. (NCT03487276)
Latest
news:
- • On March 8, 2018, InflaRx announced enrollment of the first patient in its Phase IIb study with IFX-1, a first-in-class anti-human complement factor C5a antibody, in patients suffering from moderate or severe Hidradenitis Suppurativa (HS). The randomized, double-blind, placebo-controlled, multicenter study will be conducted in approximately 50 sites in several countries, including the United States, Germany, Greece, Denmark and the Netherlands. Approximately 175 patients will be enrolled in five dose groups. After a placebo-controlled, double-blind period of 16 weeks, the study will be extended to a 28-week open-label extension phase to assess long-term efficacy and safety. The main objective of the study is the evaluation of a dose response signal, assessed by the Hidradenitis Suppurativa Clinical Response (HiSCR) score at week 16 as the primary endpoint. Additional objectives include the evaluation of safety and tolerability of IFX-1 as well as an assessment of additional efficacy and patient-reported outcome parameters.
- • On January 9, 2018, InflaRx announced the acceptance of their Investigational New Drug (IND) application by the FDA. The open IND will allow InflaRx to conduct a phase IIb study to determine efficacy and safety of IFX-1, a first-in-class anti-human complement factor C5a antibody, in patients with moderate or severe Hidradenitis Suppurativa. The randomized, double-blind and placebo-controlled multicenter study is planned to be conducted at approximately 50 sites in several countries and expected to enroll approximately 175 patients, divided equally into five cohorts. InflaRx intends to initiate the study in the first quarter of 2018.
Is
general: Yes
