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- ||||||||| izokibep (ABY-035) / ACELYRIN
Trial termination: Psoriatic Arthritis Study of Izokibep (clinicaltrials.gov) - Oct 18, 2024
P2/3, N=351, Terminated, Sponsor: ACELYRIN Inc.
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.
- 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
- || 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, Sponsor: ACELYRIN Inc.
IZO treatment was well tolerated, with no new safety signals and a safety profile generally consistent with that of other IL-17A 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.
- | Journal: Efficacy and safety of pharmacological treatment of psoriatic arthritis: a systematic literature research informing the 2023 update of the EULAR recommendations for the management of psoriatic arthritis. (Pubmed Central) - May 15, 2024
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. 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.
- ||||| 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, Sponsor: ACELYRIN Inc.
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
- | Journal: An Update on Current Clinical Management and Emerging Treatments in Hidradenitis Suppurativa. (Pubmed Central) - Apr 8, 2024
However, HS is often refractory to traditional treatments, prompting the need for newer and more effective therapies. Herein, we review current and emerging HS therapies.
- |||| izokibep (ABY-035) / ACELYRIN
Enrollment closed: Hidradenitis Suppurativa Study of Izokibep (clinicaltrials.gov) - Mar 22, 2024
P3, N=189, Active, not recruiting, Sponsor: ACELYRIN Inc.
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, Sponsor: ACELYRIN Inc.
Recruiting --> Active, not recruiting 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, Sponsor: ACELYRIN Inc.
Active, not recruiting --> Completed Phase classification: P2b --> P2/3
- | izokibep (ABY-035) / ACELYRIN
Phase classification: Hidradenitis Suppurativa Phase 2b Study of Izokibep (clinicaltrials.gov) - Feb 15, 2024
P2, N=176, Active, not recruiting, Sponsor: ACELYRIN Inc.
Phase classification: P2b --> P2/3 Phase classification: P2b --> P2
- | izokibep (ABY-035) / ACELYRIN
Phase classification: Phase 2b Pivotal Study of Izokibep in Non-infectious, Intermediate-, Posterior- or Pan-uveitis (clinicaltrials.gov) - Nov 29, 2023
P2, N=100, Recruiting, Sponsor: ACELYRIN Inc.
Phase classification: P2b --> P2 Phase classification: P2b --> P2
- || 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
Izokibep, a Unique IL-17A Inhibitor, Improves Patient-Reported Outcomes in Patients with Active Psoriatic Arthritis up to Week 46 (Poster Hall; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_3496;
P2
The GRAPPA validated PsAID-9 showed clinically important improvements in patient reported quality of life across all subdomains over weeks 16, 32 and 46. More than 70% of patients achieved marked pain control.
- izokibep (ABY-035) / Affibody, ACELYRIN
Izokibep Demonstrates Major Disease Control on ACR70, PASI100 and Enthesitis Resolution in Patients with Active Psoriatic Arthritis Treated Through 46 Weeks (Ballroom 20A; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_1891;
P2
Izokibep 80 mg demonstrated high levels of disease control with ACR70 in 52%, PASI100 in 71% and enthesitis complete resolution in 89% at week 46. Izokibep remained well tolerated, with no dose related adverse events and a safety profile generally consistent with approved IL-17A inhibitors.
- | 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) / Affibody, ACELYRIN
P2 data, Journal: Izokibep for the treatment of moderate-to-severe plaque psoriasis: a phase II, randomized, placebo-controlled, double-blind, dose-finding multicentre study including long-term treatment. (Pubmed Central) - Sep 18, 2023
Data from this phase II study indicate that izokibep is well tolerated and efficacious in the treatment of plaque psoriasis. Higher doses or more frequent dosing could be explored to further enhance response rates.
- ||| izokibep (ABY-035) / ACELYRIN
Enrollment closed: Psoriatic Arthritis Study of Izokibep (clinicaltrials.gov) - Sep 15, 2023
P2b, N=351, Active, not recruiting, Sponsor: ACELYRIN Inc.
Higher doses or more frequent dosing could be explored to further enhance response rates. Recruiting --> Active, not recruiting
- |||||||||| izokibep (ABY-035) / ACELYRIN
New P3 trial: Hidradenitis Suppurativa Study of Izokibep (clinicaltrials.gov) - Jun 15, 2023
P3, N=250, Recruiting, Sponsor: ACELYRIN Inc.
- || 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, Sponsor: ACELYRIN Inc.
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
Izokibep, a Novel IL-17A Inhibitor, Demonstrates HiSCR100 Responses in Moderate-to-Severe Hidradenitis Suppurativa: Open-Label Part A Results of a Phase 2b/3 Study (New Orleans Theater B) - Mar 4, 2023 - Abstract #AAD2023AAD_3196;
- izokibep (ABY-035) / Affibody, ACELYRIN
Trial completion: LINNAEA: A Trial of the Efficacy and Safety of Izokibep in the Treatment of Non-anterior Uveitis (clinicaltrials.gov) - Feb 1, 2023
P2, N=7, Completed, Sponsor: ACELYRIN Inc.
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- |||||| izokibep (ABY-035) / ACELYRIN
New P2b trial: Psoriatic Arthritis Study of Izokibep (clinicaltrials.gov) - Nov 21, 2022
P2b, N=300, Recruiting, Sponsor: ACELYRIN Inc.
- ||||| izokibep (ABY-035) / Affibody, ACELYRIN
Clinical: Behrens et al Izokibep (novel IL-17i fusion protein) in PsA. 16 week RCT demonstrates efficacy. No safety concerns @RheumNow #ACR22 Abstr#1597 https://t.co/PW1ESxcc0U (Twitter) - Nov 13, 2022
- | 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, Sponsor: Inmagene Biopharmaceuticals
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
Achievement of Different Treatment Targets with Izokibep Demonstrates Efficacy Benefits in Patients with Active Psoriatic Arthritis: Results from a 16-Week Randomized, Placebo-Controlled Phase 2 Clinical Trial (Room 201) - Sep 17, 2022 - Abstract #ACRConvergence2022ACR_CONVERGENCE_3329;
P2
Izokibep showed consistently high levels of response across multiple disease measures of joint and skin improvement, beginning early and with ongoing improvement. The safety profile of izokibep was generally consistent with other IL-17A inhibitors, and in this trial, event rates were mostly similar to placebo.Table 1 – Efficacy Composite Endpoint Results at Weeks 4 and Week 16Figure 1 – Minimal Disease Activity (MDA) Response at Week 12 and Week 16 Figure 2 – Mean DAS28-CRP Course by Visit until Week 16 (descriptive)
- izokibep (ABY-035) / Affibody, ACELYRIN
Izokibep Demonstrates Clinically Relevant Efficacy Benefits on Enthesitis, Dactylitis and Nail Outcomes in Active PsA Patients: A 16-week Randomized, Placebo-controlled Trial (Virtual Poster Hall) - Sep 17, 2022 - Abstract #ACRConvergence2022ACR_CONVERGENCE_2531;
P2
Patients with enthesitis at baseline had the largest improvements in PsAID. The izokibep safety profile was generally consistent with other IL-17A inhibitors; in this trial, events were mostly similar to placebo.Table 1 – Enthesitis, Dactylitis and NAPSI Efficacy Endpoints at Week 16Figure 1 – PsAID in Full Population and Those with LEI Enthesitis at Baseline
- izokibep (ABY-035) / Affibody, ACELYRIN
Izokibep Demonstrates Clinically Relevant Efficacy Benefits on Enthesitis, Dactylitis and Nail Outcomes in Active PsA Patients: A 16-week Randomized, Placebo-controlled Trial (Center City Stage) - Sep 17, 2022 - Abstract #ACRConvergence2022ACR_CONVERGENCE_2037;
P2
Patients with enthesitis at baseline had the largest improvements in PsAID. The izokibep safety profile was generally consistent with other IL-17A inhibitors; in this trial, events were mostly similar to placebo.Table 1 – Enthesitis, Dactylitis and NAPSI Efficacy Endpoints at Week 16Figure 1 – PsAID in Full Population and Those with LEI Enthesitis at Baseline
- 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, Sponsor: ACELYRIN Inc.
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
- |||| Another #IL17A molecule #Izokibep for #PsA. Also #Bimekizumab IL17A and F. Move on over #Ixekizumab, #Secukinumab and #Brodalumab. No idea what drug will win except brodalumab is not enter #psoriatic arthritis market. (Twitter) - Jun 24, 2022
- ||||||| izokibep (ABY-035) / Affibody, ACELYRIN
Clinical, P2 data: Izokibep - potent and small molecule IL-17A inhibitor Phase 2 study in PsA patients Fast onset, met ACR50 primary endpoint AE included site reaction and candida infection @RheumNow #EULAR2022 ABST#OP0258 (Twitter) - Jun 3, 2022
- |||| izokibep (ABY-035) / Affibody, ACELYRIN
Behrens et al. Izokibep (small molecular size IL17Ai, suggested to abrogate issues with tissue distribution of monoclonal abs) in PsA. ACR50 52% in 80mg, 48% in 40mg, 13% in PBO. @RheumNow #EULAR2022 https://t.co/FUS50ax79C (Twitter) - Jun 3, 2022
- ||||| izokibep (ABY-035) / Affibody, ACELYRIN
Clinical, P2 data: Izokibep Phase 2 in active PsA at Wk 16 results (80mg dose): ⭐️ACR50 52% ⭐️PASI 90 50% ⭐️Resolution of enthesitis LEI 88% ⭐️Safety profile similar to what observed in PsO. Promising for the enthesitis domain! @RheumNow OP0258 #EULAR2022 (Twitter) - Jun 3, 2022
- ||||| izokibep (ABY-035) / ACELYRIN
New P2b trial: Phase 2b Pivotal Study of Izokibep in Non-infectious, Intermediate-, Posterior- or Pan-uveitis (clinicaltrials.gov) - May 20, 2022
P2b, N=120, Recruiting, Sponsor: ACELYRIN Inc.
- | izokibep (ABY-035) / ACELYRIN
New P2b trial: Hidradenitis Suppurativa Phase 2b Study of Izokibep (clinicaltrials.gov) - May 1, 2022
P2b, N=180, Recruiting, Sponsor: ACELYRIN Inc.
- izokibep (ABY-035) / Affibody, ACELYRIN
Izokibep (ABY-035) in patients with active psoriatic arthritis – 16-week results from a phase 2 study (Congress Hall D1) - Apr 4, 2022 - Abstract #EULAR2022EULAR_985;
P2
Overall, izokibep was well tolerated. These data strongly support further clinical development.
- |||| izokibep (ABY-035) / Affibody, ACELYRIN
Enrollment open: ABY-035 in the Treatment of Subjects With Ankylosing Spondylitis (clinicaltrials.gov) - Mar 21, 2022
P2, N=300, Recruiting, Sponsor: Inmagene Biopharmaceuticals
These data strongly support further clinical development. Not yet recruiting --> Recruiting
- ||| izokibep (ABY-035) / Affibody, ACELYRIN
Enrollment change: LINNAEA: A Trial of the Efficacy and Safety of Izokibep in the Treatment of Non-anterior Uveitis (clinicaltrials.gov) - Mar 3, 2022
P2, N=20, Recruiting, Sponsor: Affibody
Not yet recruiting --> Recruiting N=110 --> 20
- ||| izokibep (ABY-035) / ACELYRIN
Trial completion, Trial completion date: AFFIRM-35: A Study to Evaluate ABY-035 in Subjects With Moderate-to-severe Plaque Psoriasis (clinicaltrials.gov) - Feb 2, 2022
P2, N=108, Completed, Sponsor: Affibody
N=110 --> 20 Active, not recruiting --> Completed | Trial completion date: Dec 2022 --> Nov 2021
- ||| izokibep (ABY-035) / Affibody, ACELYRIN
Enrollment open: LINNAEA: A Trial of the Efficacy and Safety of Izokibep in the Treatment of Non-anterior Uveitis (clinicaltrials.gov) - Jan 27, 2022
P2, N=110, Recruiting, Sponsor: Affibody
Active, not recruiting --> Completed | Trial completion date: Dec 2022 --> Nov 2021 Not yet recruiting --> Recruiting
- || izokibep (ABY-035) / Affibody, ACELYRIN
Trial initiation date: LINNAEA: A Trial of the Efficacy and Safety of Izokibep in the Treatment of Non-anterior Uveitis (clinicaltrials.gov) - Sep 26, 2021
P2, N=110, Not yet recruiting, Sponsor: Affibody
Not yet recruiting --> Recruiting Initiation date: Apr 2021 --> Oct 2021
- izokibep (ABY-035) / Affibody
[VIRTUAL] Izokibep, a novel molecule in the systemic treatement of plaque-type psoriasis - 24-week results of AFFRIM-35 study () - Sep 24, 2021 - Abstract #EADV2021EADV_2824;
- ||||| izokibep (ABY-035) / Affibody, ACELYRIN
New P2 trial: ABY-035 in the Treatment of Subjects With Ankylosing Spondylitis (clinicaltrials.gov) - Mar 12, 2021
P2, N=300, Not yet recruiting, Sponsor: Inmagene Biopharmaceuticals
- ||| izokibep (ABY-035) / Affibody
Affibody and Inmagene announce IND Clearance for Izokibep (ABY-035) for the treatment of Ankylosing Spondylitis https://t.co/miUI4PePjQ (Twitter) - Feb 10, 2021
- |||| izokibep (ABY-035) / Affibody, ACELYRIN
New P2 trial: LINNAEA: A Trial of the Efficacy and Safety of Izokibep in the Treatment of Non-anterior Uveitis (clinicaltrials.gov) - Jan 12, 2021
P2, N=110, Not yet recruiting, Sponsor: Affibody
- || izokibep (ABY-035) / Affibody, ACELYRIN
Trial completion: A Study to Investigate the Safety, Tolerability, Pharmacokinetic, and Efficacy of ABY-035/AFO2 (clinicaltrials.gov) - Nov 30, 2020
P1, N=33, Completed, Sponsor: Affibody
Initiation date: Apr 2021 --> Oct 2021 Recruiting --> Completed
- | izokibep (ABY-035) / Affibody, ACELYRIN
Trial completion date, Trial primary completion date: A Study to Investigate the Safety, Tolerability, Pharmacokinetic, and Efficacy of ABY-035/AFO2 (clinicaltrials.gov) - Jul 9, 2020
P1, N=30, Recruiting, Sponsor: Affibody
Recruiting --> Completed Trial completion date: Mar 2020 --> Oct 2020 | Trial primary completion date: Feb 2020 --> Sep 2020