- |||||||||| Journal: Next-Generation Anti-IL-17 Agents for Psoriatic Disease: A Pipeline Review. (Pubmed Central) - Feb 21, 2025
Key agents under investigation include netakimab, vunakizumab, xeligekimab, gumokimab, HB0017, CJM 112, JS005, 608, LZM012, ZL-1102, izokibep, sonelokimab, DC-806, DC-853, and LEO 153339. Both preclinical and clinical trial data for each agent are summarized, with an emphasis on their efficacy, adverse effects, immunogenicity, and future outlooks.
- |||||||||| izokibep (ABY-035) / ACELYRIN
Trial termination: Phase 2b Pivotal Study of Izokibep in Non-infectious, Intermediate-, Posterior- or Pan-uveitis (clinicaltrials.gov) - Feb 21, 2025 P2, N=96, Terminated, Both preclinical and clinical trial data for each agent are summarized, with an emphasis on their efficacy, adverse effects, immunogenicity, and future outlooks. Active, not recruiting --> Terminated; Study primary and secondary endpoints did not achieve statistical significance.
- |||||||||| izokibep (ABY-035) / ACELYRIN
Trial completion date, Trial primary completion date: Phase 2b Pivotal Study of Izokibep in Non-infectious, Intermediate-, Posterior- or Pan-uveitis (clinicaltrials.gov) - Jan 22, 2025 P2, N=96, Active, not recruiting, Active, not recruiting --> Terminated; Study primary and secondary endpoints did not achieve statistical significance. Trial completion date: Aug 2025 --> Feb 2025 | Trial primary completion date: Aug 2025 --> Feb 2025
- |||||||||| Review, Journal: Interleukin-17 Inhibitors in the Treatment of Hidradenitis Suppurativa. (Pubmed Central) - Nov 28, 2024
Recently, secukinumab received approval from both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), while bimekizumab received approval from the EMA, for the treatment of moderate-to-severe HS in adults, with ongoing clinical trials aiming to further clarify the efficacy and safety of other drugs within this class...On the other hand, innovative drugs such as sonelokimab and izokibep show promising results and are currently in phase III clinical trials. This review provides a comprehensive overview of current knowledge and scientific advances in HS, focusing on the IL-17 pathway's role and its inhibition as a treatment strategy, alongside examining the most recent and significant clinical studies on various IL-17 inhibitors in the treatment of HS.
- |||||||||| izokibep (ABY-035) / ACELYRIN
Trial termination: Psoriatic Arthritis Study of Izokibep (clinicaltrials.gov) - Oct 18, 2024 P2/3, N=351, Terminated, Active, not recruiting --> Terminated; Per our 13Aug24 press release, we announced discontinuation of internal development in this indication. This decision was not due to safety reasons.
- |||||||||| lonigutamab (VB421) / Pierre Fabre, ACELYRIN
Enrollment change, Trial completion date, Trial primary completion date: Efficacy and Safety of Lonigutamab in Subjects with Thyroid Eye Disease (TED) (clinicaltrials.gov) - Sep 26, 2024 P1/2, N=54, Recruiting, This decision was not due to safety reasons. N=38 --> 54 | Trial completion date: Oct 2024 --> May 2025 | Trial primary completion date: Oct 2024 --> May 2025
- |||||||||| lonigutamab (VB421) / Pierre Fabre, ACELYRIN
A Phase 1/2 Proof of Concept Study of Subcutaneous Lonigutamab (Anti (South Level 1 Lobby: STATION 1) - Sep 24, 2024 - Abstract #AAO2024AAO_1296; P1/2 Patients achieved clinical responses early that were maintained over the time points evaluated, including Week 12 off-treatment, supporting the potential for longer dosing intervals. Evidence from cohort 1 indicates that Loni was well tolerated and displayed clinical efficacy responses, which is further supported by cohort 2 data.
- |||||||||| izokibep (ABY-035) / ACELYRIN
Efficacy and safety of izokibep, a novel IL-17A inhibitor, in moderate-to-severe hidradenitis suppurativa: Week 12 results from a randomized, double-blind, placebo-controlled, multicenter, phase 3 study (Auditorium) - Sep 17, 2024 - Abstract #EADV2024EADV_5536; P3 Additionally, IZO-treated patients demonstrated early improvements at wk 12 across other key disease measurements, including HiSCR90, HiSCR100, pain, and quality of life. IZO treatment was well tolerated, with no new safety signals and a safety profile generally consistent with that of other IL-17A
- |||||||||| Review, Journal: Emerging therapies in the medical management of thyroid eye disease. (Pubmed Central) - Jul 10, 2024
Tocilizumab, a monoclonal antibody of interleukin 6, has played a role in the management of multiple autoimmune and inflammatory conditions and may offer promise in TED...Among the agents under investigation that aim to decrease ocular morbidity associated with TED are agents that IGF-1R, interleukin 6, and the neonatal Fc receptor. The management of TED continues to expand with novel immunologic approaches for disease therapy.
- |||||||||| izokibep (ABY-035) / ACELYRIN
Enrollment closed, Trial completion date, Trial primary completion date: Phase 2b Pivotal Study of Izokibep in Non-infectious, Intermediate-, Posterior- or Pan-uveitis (clinicaltrials.gov) - May 31, 2024 P2, N=96, Active, not recruiting, The management of TED continues to expand with novel immunologic approaches for disease therapy. Recruiting --> Active, not recruiting | Trial completion date: Oct 2024 --> Aug 2025 | Trial primary completion date: Oct 2024 --> Aug 2025
- |||||||||| izokibep (ABY-035) / ACELYRIN
EFFICACY AND SAFETY OF IZOKIBEP, A NOVEL IL-17A INHIBITOR, IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS: WEEK 16 RESULTS FROM A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER PHASE 2b/3 STUDY (C8) - May 16, 2024 - Abstract #EULAR2024EULAR_2828; P2/3 In addition to meeting the primary endpoint of ACR50, a substantial portion of IZO-treated pts achieved responses for the high-hurdle endpoints of ACR70, PASI90, PASI100, and MDA. These findings are consistent with the hypothesis that the IZO molecular construct allows optimal efficacy by IL-17A inhibition, without requiring blockade of IL-17F.
- |||||||||| izokibep (ABY-035) / ACELYRIN
Enrollment change, Trial completion date, Trial primary completion date: Hidradenitis Suppurativa Study of Izokibep (clinicaltrials.gov) - May 6, 2024 P3, N=258, Active, not recruiting, The results of this SLR informed the task force responsible for the 2023 update of the European Alliance of Associations for Rheumatology recommendations for pharmacological management of PsA. N=189 --> 258 | Trial completion date: Dec 2025 --> May 2025 | Trial primary completion date: Jun 2025 --> Jul 2024
- |||||||||| izokibep (ABY-035) / ACELYRIN
Enrollment closed: Hidradenitis Suppurativa Study of Izokibep (clinicaltrials.gov) - Mar 22, 2024 P3, N=189, Active, not recruiting, Herein, we review current and emerging HS therapies. Recruiting --> Active, not recruiting
- |||||||||| izokibep (ABY-035) / ACELYRIN
Trial completion: Hidradenitis Suppurativa Phase 2b Study of Izokibep (clinicaltrials.gov) - Mar 12, 2024 P2, N=176, Completed, Trial completion date: Feb 2024 --> Oct 2024 | Trial primary completion date: Feb 2024 --> Oct 2024 Active, not recruiting --> Completed
- |||||||||| izokibep (ABY-035) / ACELYRIN
Phase classification: Psoriatic Arthritis Study of Izokibep (clinicaltrials.gov) - Feb 23, 2024 P2/3, N=351, Active, not recruiting, Active, not recruiting --> Completed Phase classification: P2b --> P2/3
- |||||||||| Review, Journal: IL-17 Inhibition: A Valid Therapeutic Strategy in the Management of Hidradenitis Suppurativa. (Pubmed Central) - Oct 28, 2023
monoclonal antibody, is the only approved biologic agent for HS, obtaining a therapeutic response in only 50% of HS patients...Both bimekizumab and secukinumab, targeting IL-17 in different manners, have successfully completed phase III trials with promising results; the latter has recently been approved by EMA for the treatment of HS. The aim of this review is to summarize the current state of knowledge concerning the relevant role of IL-17 in HS pathogenesis, highlighting the key clinical evidence of anti-IL-17 agents in the treatment of this disease.
- |||||||||| izokibep (ABY-035) / Affibody, ACELYRIN
Journal: Clinical trial results for treatment of psoriasis with izokibep. (Pubmed Central) - Sep 19, 2023 Izokibep remained well tolerated, with no dose related adverse events and a safety profile generally consistent with approved IL-17A inhibitors. No abstract available
- |||||||||| izokibep (ABY-035) / ACELYRIN
Enrollment closed: Psoriatic Arthritis Study of Izokibep (clinicaltrials.gov) - Sep 15, 2023 P2b, N=351, Active, not recruiting, Higher doses or more frequent dosing could be explored to further enhance response rates. Recruiting --> Active, not recruiting
- |||||||||| izokibep (ABY-035) / Affibody, ACELYRIN
P1 data, Preclinical, Journal: Izokibep: Preclinical development and first-in-human study of a novel IL-17A neutralizing Affibody molecule in patients with plaque psoriasis. (Pubmed Central) - May 15, 2023 P1 In this study, the Affibody technology was used to identify and optimize a novel, small, biological molecule comprising three triple helical affinity domains, izokibep (previously ABY-035), for the inhibition of IL-17A signaling...A therapeutic decrease in joint pain was also observed in a single patient with concurrent psoriatic arthritis. The study suggests that izokibep has the potential to safely treat IL17A-associated diseases such as psoriasis, psoriatic arthritis, axial spondyloarthritis, hidradenitis suppurativa, and uveitis.
- |||||||||| izokibep (ABY-035) / ACELYRIN
Enrollment closed: Hidradenitis Suppurativa Phase 2b Study of Izokibep (clinicaltrials.gov) - May 3, 2023 P2b, N=200, Active, not recruiting, The study suggests that izokibep has the potential to safely treat IL17A-associated diseases such as psoriasis, psoriatic arthritis, axial spondyloarthritis, hidradenitis suppurativa, and uveitis. Recruiting --> Active, not recruiting
- |||||||||| izokibep (ABY-035) / Affibody, ACELYRIN
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: ABY-035 in the Treatment of Subjects With Ankylosing Spondylitis (clinicaltrials.gov) - Sep 22, 2022 P2, N=25, Terminated, Active, not recruiting --> Completed N=300 --> 25 | Trial completion date: Apr 2024 --> Aug 2022 | Recruiting --> Terminated | Trial primary completion date: Dec 2022 --> Jul 2022; The sponsor's development strategy is adjusted.
- |||||||||| izokibep (ABY-035) / Affibody, ACELYRIN
Izokibep, a Novel IL-17A Inhibitor, Improves Patient-reported Outcomes - 16-Week Results from a Placebo-controlled Phase 2 Study in Patients with Active Psoriatic Arthritis (Virtual Poster Hall) - Sep 17, 2022 - Abstract #ACRConvergence2022ACR_CONVERGENCE_1171; P2 Izokibep demonstrated a clinically meaningful, dose-dependent improvement across studied PROs, including SF36 and PsAID subdomains, in patients with active PsA, with notable improvements in sleep, pain, and function. Patients with baseline enthesitis had an even greater benefit.Table 1 - Patient-reported Outcomes at Week 16Figure 1 – SF36 Subdomains at Baseline (descriptive) and Week 16 (adjusted Means)Figure 2 – PsAID-9 Subdomains at Baseline (descriptive) and Week 16 (adjusted Means)
- |||||||||| izokibep (ABY-035) / Affibody, ACELYRIN
Izokibep, a Novel IL-17A Inhibitor, Improves Patient-reported Outcomes - 16-Week Results from a Placebo-controlled Phase 2 Study in Patients with Active Psoriatic Arthritis (Center City Stage) - Sep 17, 2022 - Abstract #ACRConvergence2022ACR_CONVERGENCE_1128; P2 Izokibep demonstrated a clinically meaningful, dose-dependent improvement across studied PROs, including SF36 and PsAID subdomains, in patients with active PsA, with notable improvements in sleep, pain, and function. Patients with baseline enthesitis had an even greater benefit.Table 1 - Patient-reported Outcomes at Week 16Figure 1 – SF36 Subdomains at Baseline (descriptive) and Week 16 (adjusted Means)Figure 2 – PsAID-9 Subdomains at Baseline (descriptive) and Week 16 (adjusted Means)
- |||||||||| izokibep (ABY-035) / Affibody, ACELYRIN
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: LINNAEA: A Trial of the Efficacy and Safety of Izokibep in the Treatment of Non-anterior Uveitis (clinicaltrials.gov) - Jul 20, 2022 P2, N=7, Active, not recruiting, Patients with baseline enthesitis had an even greater benefit.Table 1 - Patient-reported Outcomes at Week 16Figure 1 – SF36 Subdomains at Baseline (descriptive) and Week 16 (adjusted Means)Figure 2 – PsAID-9 Subdomains at Baseline (descriptive) and Week 16 (adjusted Means) Recruiting --> Active, not recruiting | N=20 --> 7 | Trial completion date: Dec 2023 --> Nov 2022 | Trial primary completion date: Dec 2023 --> Aug 2022
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