Date: 2017-12-04
Type of
information: Publication of results in a medical journal
phase: 2
Announcement: publication of results in The Journal of Investigative Dermatology
Company: XBiotech (USA - TX)
Product: MABp1 (bermekimab)
Action
mechanism:
- monoclonal antibody. MABp1 is a monoclonal antibody targeting interleukin-1 alpha (IL-1 alpha).
Disease: Hidradenitis Suppurativa
Therapeutic
area: Dermatological diseases - Immunological diseases
Country: Greece
Trial
details:
- The 20-patient double-blind, placebo-controlled study was designed to evaluate the safety and efficacy of MABp1, the Company’s True Human antibody targeting interleukin-1 alpha (IL-1?), in patients with HS not eligible for anti-TNF therapy. Patients were randomized 1:1 to receive either MABp1 or placebo every 2 weeks for 12 weeks. Patients in the study underwent primary assessment of efficacy using Hidradenitis Suppurativa Clinical Response (HiSCR) scores at 12 weeks, continued by a follow up phase to assess time to relapse after an additional 12 weeks without therapy. Efficacy measures include assessment of HiSCR scores, a validated method for evaluating efficacy in HS patients, as well as quality of life assessment and ultrasonographic evaluation.
Latest
news:
- • On December 4, 2017, XBiotech announced the publication of data from its randomized phase 2 study evaluating XBiotech’s True Human™ antibody, MABp1, as a treatment for Hidradenitis Suppurativa (HS). The results have been published in the Journal of Investigative Dermatology in a manuscript titled, “MABp1 Targeting Interleukin-1alpha for Moderate to Severe Hidradenitis Suppurativa not Eligible for Adalimumab: A Randomized Study.” The publication highlights the efficacy of MABp1, in which the study’s primary endpoint was met in 60% of MABp1 treated patients compared to 10% of placebo patients (odds ratio 13.50, 95% confidence intervals 1.19-152.51; p=0.035). The clinical efficacy of MABp1 was maintained until week 24 (12 weeks after discontinuation of treatment) at which time point, no patients treated with placebo had a positive HiSCR score (0%) compared to four out of 10 patients (40%) treated with MABp1. Treatment with MABp1 was also accompanied by better patient-reported outcomes. Decrease of the visual analogue scale (VAS) was found in 30% of placebo patients compared with 70% of patients treated with MABp1.
- • On September 7, 2017, XBiotech announced the presentation of results from a randomized Phase 2 study evaluating XBiotech’s True Human™ antibody, MABp1, at the European Academy of Dermatology and Venereology (EADV) Congress in Geneva Switzerland. Prof. Evangelos Giamarellos-Bourboulis, M.D., Ph.D., who supervises the Outpatients Department for HS of the 4th Department of Medicine at Attikon University Hospital in Greece where the study was conducted and also served as the Principal Investigator of the study.
- XBiotech announced topline results earlier this year (see below), reporting that the study met its primary endpoint and demonstrated a significant improvement in HS patients treated with MABp1 compared to control after 12 weeks of therapy (Response rate of 60% vs 10%, respectively (p=0.035)). The 20 patient double-blind, placebo-controlled study was designed to evaluate the safety and efficacy of MABp1, the Company’s True Human antibody targeting interleukin-1 alpha (IL-1?), in patients with HS not eligible for anti-TNF therapy. Patients were randomized 1:1 to receive either MABp1 or placebo every 2 weeks for 12 weeks. Patients in the study underwent primary assessment of efficacy using Hidradenitis Suppurativa Clinical Response (HiSCR) scores at 12 weeks, continued by a follow up phase to assess time to relapse after an additional 12 weeks without therapy. Efficacy measures include assessment of HiSCR scores, a validated method for evaluating efficacy in HS patients, as well as quality of life assessment and ultrasonographic evaluation.
- • On February 16, 2017, XBiotech announced topline results from an investigator sponsored randomized Phase 2 study evaluating XBiotech’s True Human antibody, MABp1, as a treatment for Hidradenitis Suppurativa, a serious and debilitating chronic inflammatory skin disorder. The study met its primary endpoint, demonstrating significant improvement of Hidradenitis Suppurativa (HS) patients compared to control after 12 weeks of therapy (Response rate of 60% vs 10%, respectively (p=0.035)).
- A 20 patient double-blind, placebo-controlled study was designed to evaluate the safety and efficacy of MABp1, the Company’s True Human antibody targeting interleukin-1 alpha (IL-1 alpha), in patients with HS not eligible for anti-TNF therapy. Patients were randomized 1:1 to receive either MABp1 or placebo every 2 weeks for 12 weeks. Patients in the study underwent primary assessment of efficacy using Hidradenitis Suppurativa Clinical Response (HiSCR) scores at 12 weeks, continued by a follow up phase to assess time to relapse after an additional 12 weeks without therapy. Efficacy measures include assessment of HiSCR scores, a validated method for evaluating efficacy in HS patients, as well as quality of life assessment and ultrasonographic evaluation.
- “The overall response rate observed in the data is, in my opinion, groundbreaking for the treatment of HS,” Dr. Giamarellos-Bourboulis commented, “I am truly encouraged by these results and very much look forward to the future use of MABp1 as a treatment for this devastating condition.” Prof. Giamarellos-Bourboulis is supervising the Outpatients Department for HS of the 4th Department of Medicine of ATTIKON University Hospital in Greece where the study was conducted. This center is a well-recognized European reference center for HS with more than 20 peer-reviewed publications in the field, conduct of four randomized trials with biological therapies and active participation in the PIONEER studies providing registration of adalimumab for HS.
Is
general: Yes
