[Translation] A randomized, double-blind, placebo-controlled, multicenter phase III clinical study to evaluate the efficacy and safety of AK111 injection in the treatment of active ankylosing spondylitis

主要目的：评估 AK111 注射液对比安慰剂治疗活动性强直性脊柱炎（AS）受试者的有效性。次要目的：评估 AK111 注射液对比安慰剂治疗活动性 AS 受试者的安全性。评估 AK111 注射液对比安慰剂治疗活动性 AS 受试者对生活质量的影响。评估 AK111 注射液治疗活动性 AS 受试者的药代动力学（PK）和免疫原性。探索性目的：探索 AK111 注射液治疗活动性 AS 受试者外周血清中白介素 17A（IL-17A）的水平较基线期的变化情况。

[Translation]

Primary objective: To evaluate the efficacy of AK111 injection versus placebo in the treatment of subjects with active ankylosing spondylitis (AS). Secondary objective: To evaluate the safety of AK111 injection versus placebo in the treatment of subjects with active AS. To evaluate the effect of AK111 injection versus placebo on the quality of life of subjects with active AS. To evaluate the pharmacokinetics (PK) and immunogenicity of AK111 injection in the treatment of subjects with active AS. Exploratory objective: To explore the changes in the level of interleukin 17A (IL-17A) in the peripheral serum of subjects with active AS treated with AK111 injection compared with the baseline period.

Start Date10 Nov 2023

Sponsor / Collaborator

Akeso Biopharma Co., Ltd.

NCT06378697

/ RecruitingPhase 3

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of AK111 in the Treatment of Subjects With Active Ankylosing Spondylitis

This is a randomized, double-blind, placebo-controlled, multi-center phase III clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with active ankylosing spondylitis.

Start Date10 Nov 2023

Sponsor / Collaborator

Akeso Biopharma Co., Ltd.

NCT06061471

/ CompletedPhase 2

A Randomized, Double-blind, Phase II Clinical Study to Evaluate the Efficacy and Safety of AK111 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis

This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with moderate to severe plaque psoriasis.

Start Date22 Sep 2023

Sponsor / Collaborator

Akeso Biopharma Co., Ltd.

100 Clinical Results associated with Gumokimab

100 Translational Medicine associated with Gumokimab

100 Patents (Medical) associated with Gumokimab

Literatures (Medical) associated with Gumokimab

01 Feb 2023·Dermatology and therapy

Efficacy, Safety and Pharmacokinetics of IL-17 Monoclonal Antibody Injection (AK111) in Patients with Moderate-to-Severe Plaque Psoriasis: A Randomized, Double-Blinded, Placebo-Controlled Phase Ib Multidose Escalation Clinical Study

Article

Author: Jin, Hongzhong ; Xia, Yu ; Li, Baiyong ; Jiang, Congjun ; Wang, Guoqin ; He, Zhimei ; Zhang, Wenhui ; Deng, Liehua ; Ni, Xiang ; Zhang, Wanlu ; Chen, Benchao ; Zhou, Huan ; Chen, Rui ; Zhang, Min

OBJECTIVES:

To evaluate the safety, tolerability, immunogenicity, and induced expression of skin biomarkers of AK111 injection after multiple administrations in subjects with moderate-to-severe plaque psoriasis.

METHODS:

This study is a randomized, double-blinded, placebo-parallel-controlled study using a dose escalation mode of multiple doses. A total of 48 subjects were sequentially randomized to receive each AK111 dose regimen (75 mg, 150 mg, 300 mg, 450 mg) or the corresponding placebo. All subjects were treated with the study drug at weeks 0, 1, 4, and 8 and were unblinded at week 12, with the placebo group ending and the AK111 group being followed up to 20 weeks.

RESULTS:

At week 12, compared with placebo, the percentage of subjects achieving Psoriasis Area and Severity Index 75 (PASI75) and static Physician Global Assessment (sPGA) 0/1 in the AK111 75 mg-450 mg dose groups was significantly increased, and higher PASI90 was achieved in the 150 mg, 300 mg, and 450 mg dose groups than in the 75 mg group. All efficacy indicators were maintained at week 20. The incidence of treatment-emergent anti-drug antibodies (ADAs) was 0% (0/48). Neutralizing antibodies (NAbs) were not detected in any subject. The proportion of subjects who reported any treatment-emergent adverse event (TEAE) was 75.0% in the AK111 group, similar to the 66.7% in the placebo group. The most commonly reported adverse events were hyperglycemia, elevated blood pressure, and hypokalemia. The AK111 pharmacokinetics showed approximate dose proportionality with regard to the maximum observed concentration (C_max) and area under the curve from 0 to the time of the last quantifiable concentration (AUC_0-t) following subcutaneous injection doses of 150-450 mg.

CONCLUSIONS:

After moderate-to-severe plaque psoriasis subjects received multiple subcutaneous AK111 injections of 150-450 mg, AK111 exposure increased in a roughly dose-proportional relationship. AK111 was safe and tolerable. In subjects with moderate-to-severe plaque psoriasis, AK111 demonstrated encouraging preliminary efficacy, which was sustained for a relatively long time after the last dose administration.

CLINICAL TRIAL REGISTRATION:

The clinical trial identification number is NCT05504317.

Frontiers in pharmacology

Population pharmacokinetic/pharmacodynamic analysis of AK111, an IL-17A monoclonal antibody, in subjects with moderate-to-severe plaque psoriasis

Article

Author: Ni, Xiang ; Chen, Benchao ; He, Zhimei ; Hu, Pei ; Wang, Max ; Li, Baiyong ; Qiao, Ju ; Wang, Guoqin ; Li, Qian ; Chen, Rui ; Jin, Hongzhong ; Xia, Michelle

AK111 is an innovative IL-17A antibody, presenting high affinity to IL-17A and showing similar pharmacokinetic (PK) characteristics to those of typical immunoglobulin (Ig) G1 antibodies. To optimize the dosage regimen for phase 2/3 clinical trials, PK and pharmacodynamics (PD) of AK111 were first characterized in Chinese moderate-to-severe plaque psoriasis patients in a phase 1b study. AK111 PK serum sample and Psoriasis Area and Severity Index (PASI) score data were collected from 48 moderate-to-severe psoriasis patients in this study. Non-linear mixed-effects modeling was used for the population PK/PD analysis. A one-compartment model with a first-order absorption and a first-order elimination best described the PK behavior of AK111. The apparent systemic clearance was 0.182 L/day, and the central volume was 6.65 L. The exposure–response relationship was characterized using an indirect response model. The pharmacological effect of AK111 was described in the form of inhibiting the formation of psoriatic plaque, whereas placebo was quantified in the form of promoting the degradation of psoriatic skin lesions. The maximum effect of drug effect (Imax) and placebo effect (PLBmax) was 1 and 0.429, respectively. The rate constant for psoriatic plaque production (Kin) was 0.474 PASI/day and psoriatic plaque loss (Kout) was 0.024 day−1. The body surface area (BSA) affected by psoriasis was identified as a significant covariate on Kout. The simulation results confirmed that all of the predicted PASI90 response rates at week 12 were higher than 60% at 150 and 300 mg dose levels with different regimens and could reach higher than 80% at week 24. We hope this first PK/PD study of AK111 in Chinese moderate-to-severe plaque psoriasis patients will be of help in the further clinical development of AK111 and provide a reference to the dosage optimization for similar antibodies with a long half-life.

News (Medical) associated with Gumokimab

27 Jan 2025

·www.prnewswire.com

Akeso's Gumokimab Monoclonal Antibody (IL-17) New Drug Application for the Treatment of Moderate to Severe Psoriasis Accepted by NMPA

HONG KONG, Jan. 26, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that the New Drug Application (NDA) of its internally-developed IL-17-targeting monoclonal antibody gumokimab (AK111) has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of moderate to severe plaque psoriasis. The strategic combination of drugs such as gumokimab and ebronucimab (PCSK9) to address the differentiated treatment needs of psoriasis has further enhanced the company's overall product synergy in the autoimmune disease field. Gumokimab is the eighth successfully approved drug developed independently by Akeso (with six already approved for market), and it is also the third non-oncology innovative drug, following ebronucimab (PCSK9) and ebdarokimab (IL-12/IL-23), to progress to the commercialization stage. Gumokimab has been evaluated in four clinical studies involving patients with moderate to severe plaque psoriasis, including one pivotal Phase III clinical trial (AK111-301) and three supportive studies. Efficacy data show that gumokimab acts quickly, with significant therapeutic improvement observed after just 2 weeks of treatment. S hort-term Efficacy: At week 12, the PASI 75 response rate approached 96%, with an sPGA 0/1 response rate nearing 90%. The PASI 90 response rate was close to 80%, and the PASI 100 response rate exceeded 40%, all efficacy measures significantly superior to the placebo group. Over 80% of patients achieved a PASI 90 response, and approximately 50% achieved a PASI 100 response. Long-term Efficacy: Gumokimab monotherapy demonstrated sustained efficacy over 52 weeks, with continuous improvement and long-lasting maintenance. By week 52, the PASI 75 response rate approached 100%, with stable sPGA 0/1 response rates. The PASI 90 and PASI 100 response rates further improved to nearly 90% and 65%, respectively. Safety: During both the placebo-controlled phase and the overall treatment phase, the incidence of adverse events was comparable between the gumokimab and placebo groups, with the gumokimab group showing slightly lower values across all metrics. Professor Xu Jinhua, the principal investigator of the pivotal registration study of gumokimab, professor at Huashan Hospital, Fudan University, stated: "There is an increasing demand for medications that offer rapid onset, short-term efficacy, long-term stability, and good tolerability. Gumokimab, an IL-17A IgG1 monoclonal antibody, directly targets the IL-17RA pathway, a key driver of psoriasis, providing faster and more effective results. Data from four studies demonstrate its potential to better meet patient needs, particularly in achieving near-clearance of lesions and maintaining disease stability. Moreover, the incidence of adverse events with gumokimab is comparable to that of the placebo, indicating good safety and tolerability. We eagerly anticipate the early availability of Gumokimab as a more efficient treatment option for psoriasis patients in China." Dr. Yu Xia, Founder, Chairwoman, and CEO of Akeso, stated: "We are excited about the outstanding results of gumokimab in clinical trials and the successful submission of its new drug application for market approval. I would like to express my sincere gratitude to all the participants in the project and to all the patients who took part in the clinical trials for their hard work and trust. Psoriasis patients are in urgent need of better treatment options, and Akeso is addressing this with ebdarokimab and gumokimab, which target different disease pathways and complement each other in treatment, allowing us to meet a wide range of patient needs. With the successful launch of products such as ebronucimab (PCSK9), ebdarokimab (IL-12/IL-23) and gumokimab (IL-17), as well as the efficient advancement of innovative non-oncology drugs targeting multiple indications, including manfidokimab (IL-4R), IL-4R/ST2 bispecific antibody, and therapies for neurodegenerative diseases, the vitality and synergy of our product portfolio are growing stronger. This progress significantly enhances Akeso's global competitiveness in the non-oncology business segment. At the same time, with the development and optimization of a more systematic, refined, and efficient commercialization team, we have formulated a comprehensive and scientific commercialization strategy for our non-oncology products. This strategy is designed to accelerate market expansion, positioning our non-oncology business as a powerful driver of the company's high-quality growth." About gumokimab Gumokimab is an innovative, humanized IL-17 (interleukin-17) monoclonal antibody developed by Akeso for the treatment of autoimmune diseases such as psoriasis and ankylosing spondylitis. IL-17 is a pro-inflammatory cytokine primarily secreted by activated Th17 cells, which binds to its receptor (IL-17R) on cell surfaces, mediating immune-inflammatory responses and playing a critical role in the pathogenesis of psoriasis and ankylosing spondylitis. Gumokimab specifically targets IL-17, blocking the IL-17/IL-17R signaling pathway to inhibit the onset and progression of related immune-inflammatory responses. Currently, the NDA for gumokimab in moderate-to-severe plaque psoriasis has been accepted by the NMPA, and a phase III clinical trial for ankylosing spondylitis is ongoing. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit and follow us on Linkedin, and X . SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3NDADrug ApprovalClinical ResultPhase 2

28 Dec 2021

·www.biospace.com

Akeso's IL-17A Monoclonal Antibody (Gumokimab) Completion of Patient Enrollment in Phase II Clinical Trial For The Treatment Of Ankylosing Spondylitis

Today, Akeso, Inc. (09926.HK) announces that Gumokimab (IL-17A monoclonal antibody, AK111), an innovative drug independently developed by the Company for the treatment of active ankylosing spondylitis has been completed. Such clinical trial aims to evaluate the efficacy and safety of Gumokimab for the treatment of patients with active ankylosing spondylitis. Ankylosing spondylitis is a chronic inflammatory disease that affects the medial joints and can lead to spinal deformity and loss of function to patients.IL-17, a key inflammatory cytokine in the pathogenesis of ankylosing spondylitis, has demonstrated good commercial value with its unique efficacy and safety advantages, and has become a new therapeutic target. Secukinumab and Ixekizumab, which have the same drug targets as AK111, have been approved by the Food and Drug Administration of the United States (FDA) for the treatment of ankylosing spondylitis. The global sales of IL-17A monoclonal antibody drugs amounted to approximately US$5.783 billion in 2020. At present, there is no independently developed monoclonal antibody drugs against IL-17 approved for marketing in China, resulting in strong clinical demand. Gumokimab, being an independently developed and innovative drug in China, is expected to bring new hope to patients with ankylosing spondylitis in the future. INFORMATION ABOUT GUMOKIMAB (IL-17A MONOCLONAL ANTIBODY, AK111) Gumokimab is a novel drug targeting IL-17A of autoimmune treatment diseases independently developed by the Company. Gumokimab is intended to be used for the treatment of diseases such as psoriasis and ankylosing spondylitis. Through combination of competitive blockers, namely IL-17A and IL-17R, and blocking the biological activities of IL-17, Gumokimab has reached the efficacy in immune-related diseases in clinical therapies.The clinical trial of Gumokimab, which involves multiple subcutaneous injections of escalating doses to subjects with moderate-to-severe plaque psoriasis, has completed. The clinical trial results have shown that Gumokimab can significantly improve the condition of subjects with psoriasis, including the proportion of patients with Psoriasis Area and Severity Index (PASI) reaching 100, showing Gumokimab is of good safety and tolerability.Currently, the assessment of primary endpoints of Gumokimab for treatment of all subjects with moderate-to-severe plaque psoriasis has been completed, and it is expected to advance to phase III clinical trial in early 2022.

AntibodyInnovative Drug

18 Jun 2021

·www.globenewswire.com

Axial Spondyloarthritis Pipeline: Drug Pipeline, Regulatory Events and Clinical Trials in the Spotlight| Insights by DelveInsight

Los Angeles, June 17, 2021 (GLOBE NEWSWIRE) -- Axial Spondyloarthritis Pipeline: Drug Pipeline, Regulatory Events and Clinical Trials in the Spotlight| Insights by DelveInsight The report offers the most up-to-date information on Axial Spondyloarthritis pipeline products being developed by notable companies such as Pfizer, Suzhou Zelgen Biopharmaceuticals, Clover Biopharmaceuticals, FunPep Co Ltd., Kinevant Sciences, Izana Bioscience, Mycenax Biotech, and UCB Biopharma, among others. DelveInsight’s ‘Axial Spondyloarthritis (axSpA) Pipeline Insights’ report offers exhaustive coverage of the emerging therapies in different stages of development from pre-clinical till late-stage, along with dormant, inactive, and abandoned therapeutic agents. Some of the important takeaways from the Axial Spondyloarthritis Pipeline report: Request for Sample to know more about the therapies expected to make grab the maximum patient pool @ Axial Spondyloarthritis Emerging Therapies and Forecast The Axial Spondyloarthritis Pipeline reports lay down a thorough coverage of the ongoing clinical trials, collaborations taking place in the domain, recent happenings in the Axial Spondyloarthritis pipeline space, and growth prospects across the Axial Spondyloarthritis domain. Axial Spondyloarthritis: Overview Axial Spondyloarthritis is a chronic, inflammatory rheumatic disease that affects primarily the axial joints leading to severe pain, stiffness, and fatigue. It starts with an early inflammatory phase in which there is no structural damage in the sacroiliac joints (non-radiographic disease) progressing to later stages in which structural damage is visible on X‑ray scans of the sacroiliac joints as erosions, sclerosis, or bony bridges (radiographic disease; also known as Ankylosing Spondylitis). Discover more about the disease, treatments, and pipeline therapies @ axSpA Pipeline Assessment Axial Spondyloarthritis Pipeline Drugs Request for Sample to know more @ Axial Spondyloarthritis Pipeline Analysis, Key Companies, and Futuristic Trends Axial Spondyloarthritis Therapeutics Assessment The Axial Spondyloarthritis Pipeline report presents a kaleidoscopic view of the axSpA emerging novel therapies segmented by Stage, Product Type, Route of Administration (RoA), Molecule Type, Target, and Mechanism of Action. By Product Type By Stage By Molecule Type By Route of Administration By Mechanism of Action By Targets For rich insights into merging therapies and assessment, visit Axial Spondyloarthritis Pipeline: Emerging Novel Therapies Scope of the Axial Spondyloarthritis Pipeline Report Coverage: GlobalKey Players: Izana Bioscience, UCB, Sun Pharma Global, Akeso Biopharma, Kinevant Sciences, Jiangsu Hengrui Medicine Co., Suzhou Zelgen Biopharmaceuticals, Clover Biopharmaceuticals, Mycenax Biotech, Boehringer Ingelheim, and Qyuns Therapeutics among others.Key Axial Spondyloarthritis Pipeline Therapies: Namilumab , Bimekizumab, Tofacitinib, Tildrakizumab, AK-111, NDI 031232, Gimsilumab, QX002N, SHR-0302, Jaktinib, SCB-808, FPP003, KIN-1901, ENIA11, BI 730357, and QX002N among others. Discover more about the report offerings @ axSpA Emerging Therapies, Treatments, and Ongoing Clinical Trials Table of Contents Get in touch with our Business executive for Regulatory Analysis, Licensing Services, and Consulting Solutions Related Reports Axial Spondyloarthritis MarketDelveInsight's "Axial Spondyloarthritis Market Insights, Epidemiology, and Market Forecast-2030" report. Non-Radiographic Axial Spondyloarthritis MarketDelveInsight's "Non-Radiographic Axial Spondyloarthritis (nr-AxSpA) Market Insights, Epidemiology, and Market Forecast-2030" report. Spondylolisthesis Market InsightsDelveInsight's “Spondylolisthesis Market Insights, Epidemiology, and Market Forecast-2030" report. Ankylosing Spondylitis MarketDelveInsight’s ‘Ankylosing Spondylitis Market Insights, Epidemiology, and Market Forecast–2030’ report. Global Kinase Inhibitor In Autoimmune Diseases MarketDelveInsight’s ‘Global Kinase Inhibitor in Autoimmune Diseases Market Insights and Market Forecast – 2030’ report. Adenosine Deaminase Severe Combined Immunodeficiency MarketDelveInsight's "Adenosine Deaminase-Severe Combined Immunodeficiency Market Insights, Epidemiology, and Market Forecast-2030" report. Adult-Onset Still Disease MarketDelveInsight’s “Adult-onset Still’s Disease Market Insights, Epidemiology, and Market Forecast – 2030” report. Browse through our posts ABSSSI Pipeline Analysis Parkinson's Disease Risk FactorsWearable Healthcare Devices Market About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. For more insights, visit Pharma, Healthcare, and Biotech News

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100 Deals associated with Gumokimab

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Psoriasis	NDA/BLA	CN	Akeso Biopharma Co., Ltd.	27 Jan 2025
Ankylosing Spondylitis	Phase 3	CN	Akeso Biopharma Co., Ltd.	10 Nov 2023
Plaque psoriasis	Phase 3	CN	Akeso Biopharma Co., Ltd.	31 Mar 2023
Axial Spondyloarthritis	Phase 2	CN	Akeso Biopharma Co., Ltd.	07 Jun 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06066125 (AK111-301, NEWS) Manual	Phase 3	Plaque psoriasis	-	古莫奇单抗	lxqmntozlf(mvzipuoulz) = qtubeltcnq yrygnzpnsx (taycbxzvia ) View more	Positive	28 Oct 2024
				Placebo	-
NCT05096364 (NEWS) Manual	Phase 2	Plaque psoriasis	250	古莫奇 300mg (W0/1/3/4 + 第1组)	tdqquyaoyp(jocpjiltxr) = umcswcjhob nmfiastjcl (tgxpdcwoun ) View more	Positive	02 Oct 2024
				古莫奇 300mg (W0/2/4/6/8 + 第2组)	tdqquyaoyp(jocpjiltxr) = vfwgabalnx nmfiastjcl (tgxpdcwoun ) View more
NEWS Manual	Phase 3	Psoriasis	-	AK111	lnhfogwumw(mufeybltnq) = 与对照组相比,显著提高达到PASI 75的患者比例 yccfrxwmeq (sgwmwlphhl ) View more	Positive	02 Dec 2023
				placebo

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