Clinical Trials

Date: 2017-09-07

Type of information: Results

phase: 2a

Announcement: results

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: Greece

Trial details:

• The trial enrolls patients with moderate to severe Hidradenitis Suppurativa (HS). The primary goal of the trial is to evaluate the safety and tolerability of IFX-1 administered over 8 weeks in these patients. In addition the trial aims to characterize the pharmacokinetics and pharmacodynamics of IFX-1 as well as to generate preliminary data on the efficacy of IFX-1 on clinical endpoints (e.g., Hidradenitis Suppurativa Clinical Response (HiSCR), Dermatology Life Quality Index (DLQI), Visual Analog Scale (VAS) for disease, VAS for pain, Hidradenitis Suppurativa - Physician's Global Assessment (HS-PGA), Modified Sartorius Score (mSS)). (NCT03001622)

Latest news:

• • On September 7, 2017, InflaRx announced positive topline data from an exploratory Phase IIa clinical trial with  IFX-1, a first-in-class anti-human complement factor C5a monoclonal antibody, in patients suffering from moderate to severe Hidradenitis Suppurativa.
• This open label, single center study recruited twelve patients with moderate to severe HS, who were not eligible for or failed to respond to previous therapy with biologicals. Patients were treated with weekly intravenous injections of IFX-1 for eight consecutive weeks and were then followed up for an additional period of twelve weeks. The study was conducted to primarily assess the safety and tolerability of IFX-1 in HS patients. Initial efficacy of treatment was assessed through response rate, as measured by the validated and clinically relevant Hidradenitis Suppurativa Clinical Response (HiSCR) score. This score is defined as a reduction of 50% or higher in inflammatory lesion count (abscesses and inflammatory nodules) and no increase in abscesses or draining fistulas when compared with baseline. The severity and extent of HS was assessed using the Hurley Stages scoring system, which describes three distinct clinical stages of HS.
• In the study, all twelve patients were categorized as Hurley Stage III and therefore most progressed diseased patients, demonstrating a mean duration of HS of 19.9 years. Nine out of the twelve patients had previously failed to respond to an anti-TNF-alpha antibody, the only approved biological treatment in this indication. The mean combined number of lesions (abscesses and inflammatory nodules) and draining fistulas at baseline was 6.4. and 11.2, respectively. Assessment of the HiSCR score demonstrated a response rate of 75% (nine out of twelve patients) at the end of the treatment period and 83% (ten out of twelve) at the end of the twelve week follow up period. The weekly intravenous infusions of IFX-1 were well tolerated. No drug-related adverse events were detected and no infusion-related, allergic or anaphylactic reactions were observed.
• In addition, positive trends of clinical improvement were also detected with other relevant parameters, including the dermatology life-quality index, a patient-reported outcome measure.
• InflaRx will present further details on these results at the 16th European Meeting on Complement in Human Disease, taking place in Copenhagen from September 8 to 12 as well as the 26th Meeting of the European Academy of Dermatology and Venerology in Geneva from September 13 to 17.
• • On January 4, 2017, InflaRx,announced enrollment of the first patient into a Phase II trial to assess IFX-1 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.

 

Is general: Yes