An Open-label, Single-arm, Multi-center Study to Evaluate the Long-term Safety and Efficacy of AK101 Injection in Subjects With Moderate-to-severe Plaque Psoriasis

This is an open-label Phase III clinical study to evaluate the long-term safety and efficacy of AK101 injection in subjects with moderate-to-severe plaque psoriasis.

Start Date08 Apr 2022

Sponsor / Collaborator

Akeso Biopharma Co., Ltd.

CTR20220206 / CompletedPhase 3

单臂、开放、多中心评价AK101注射液治疗中、重度斑块型银屑病受试者长期安全性和有效性临床研究

[Translation] A single-arm, open, multicenter clinical study to evaluate the long-term safety and efficacy of AK101 injection in the treatment of moderate to severe plaque psoriasis

主要目的：评价AK101注射液治疗中国中、重度斑块型银屑病受试者的长期安全性。次要目的：评估AK101注射液治疗中国中、重度斑块型银屑病受试者的长期有效性；评估AK101注射液治疗中国中、重度斑块型对银屑病受试者的长期生活质量的影响；评估AK101注射液治疗中国中、重度斑块型银屑病受试者的长期药代动力学（PK）和免疫原性（ADA）。

[Translation]

Primary objective: To evaluate the long-term safety of AK101 injection in the treatment of Chinese subjects with moderate to severe plaque psoriasis. Secondary objectives: To evaluate the long-term effectiveness of AK101 injection in the treatment of Chinese subjects with moderate to severe plaque psoriasis; To evaluate the effect of AK101 injection in the treatment of Chinese subjects with moderate to severe plaque psoriasis on the long-term quality of life; To evaluate the long-term pharmacokinetics (PK) and immunogenicity (ADA) of AK101 injection in the treatment of Chinese subjects with moderate to severe plaque psoriasis.

Start Date28 Mar 2022

Sponsor / Collaborator

Akeso Biopharma Co., Ltd.

NCT05120297 / CompletedPhase 3

A Study to Evaluate the Efficacy and Safety of AK101 in Subjects With Moderate-to-severe Plaque Psoriasis

This is a randomized, double-blind, placebo-controlled, multicentered phase III clinical study to evaluate the efficacy and safety of AK101 in the treatment of subjects with moderate-to-severe plaque psoriasis.

Start Date29 Nov 2021

Sponsor / Collaborator

Akeso Biopharma Co., Ltd.

100 Clinical Results associated with Ebdarokimab

100 Translational Medicine associated with Ebdarokimab

100 Patents (Medical) associated with Ebdarokimab

Literatures (Medical) associated with Ebdarokimab

01 Sep 2024·CLINICAL RHEUMATOLOGY

Prioritizing drug targets in systemic lupus erythematosus from a genetic perspective: a druggable genome-wide Mendelian randomization study

Article

Author: Wu, Haiyang ; Lin, Zikai ; Xie, Yingying ; Gao, Yuan ; Chen, Fengzhen ; Peng, Chusheng ; Zhou, Youtao

Abstract:

Objectives:

Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease with an unsatisfactory state of treatment. We aim to explore novel targets for SLE from a genetic standpoint.

Methods:

Cis-expression quantitative trait loci (eQTLs) for whole blood from 31,684 samples provided by the eQTLGen Consortium as well as two large SLE cohorts were utilized for screening and validating genes causally associated with SLE. Colocalization analysis was employed to further investigate whether changes in the expression of risk genes, as indicated by GWAS signals, influence the occurrence and development of SLE. Targets identified for drug development were evaluated for potential side effects using a phenome-wide association study (PheWAS). Based on the multiple databases, we explored the interactions between drugs and genes for drug prediction and the assessment of current medications.

Results:

The analysis comprised 5427 druggable genes in total. The two-sample Mendelian randomization (MR) in the discovery phase identified 20 genes causally associated with SLE and validated 8 genes in the replication phase. Colocalization analysis ultimately identified five genes (BLK, HIST1H3H, HSPA1A, IL12A, NEU1) with PPH4 > 0.8. PheWAS further indicated that drugs acting on BLK and IL12A are less likely to have potential side effects, while HSPA1A and NEU1 were associated with other traits. Four genes (BLK, HSPA1A, IL12A, NEU1) have been targeted for drug development in autoimmune diseases and other conditions.

Conclusions:

.This study identified five genes as therapeutic targets for SLE. Repurposing and developing drugs targeting these genes is anticipated to improve the existing treatment state for SLE. Key Points• We identified five gene targets of priority for the treatment of SLE, with BLK and IL12A indicating fewer side effects.• Among the existing drugs that target these candidate genes, Ustekinumab, Ebdarokimab, and Briakinumab (targeting the IL12 gene) and CD24FC (targeting HSPA1A) may potentially be repurposed for the treatment of SLE.

News (Medical) associated with Ebdarokimab

08 Jan 2024

·www.biospace.com

Akeso to Present at the 42nd Annual J.P. Morgan Healthcare Conference and Share Its Corporate & Innovative Clinical Development Roadmap

HONG KONG, Jan. 8, 2024 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso," "we," or the "Company") today announced that Michelle Xia, Ph.D, the founder, chairwoman, president, and CEO of Akeso, will deliver a keynote speech focusing on the Company's achievements in the development of new bispecific antibody drug therapeutics and the Company's 2024 key milestones at the 42nd Annual J.P. Morgan Healthcare Conference, to be held January 8-11, 2024 in San Francisco, California. The presentation will take place on Tuesday, January 9, at 4:30 PM PST. Thanks to clear strategic vision and efficient execution by our leadership and team,we delivered yet another exceptional performance, surpassing expectations and successfully achieving all of our stated goals in 2023. We are seeking to achieve the followings potential milestones that may take place in 2024 and into early 2025: Approval of four NDAs/sNDAs across five indications NDAs/sNDAs filing across four indications for three drugs Topline data readout from up to five registrational trials Completing enrollment for up to four registrational trials Initiating up to five new Phase III trials In addition, Akeso continues to plan for first-in-human clinical trials for a range of products currently in preclinical evaluation, including, for the first time, an antibody-drug conjugate (ADC). Updated Clinical Data and Milestone Outlook for Ivonescimab (PD-1/VEGF Bispecific) We currently have three Phase III clinical trials for ivonescimab at varying stages of progress: AK112-301, for which the NDA has been submitted for approval to the CDE, AK112-303, for which enrollment has completed AK112-306, for which we are currently enrolling. We are presenting updated data from our Phase II clinical trials, supporting our rapid development of ivonescimab across multiple indications. Updated Data for AK112-201 (NCT04736823) AK112-201 is an open-label, Phase II study evaluating ivonescimab plus chemotherapy across three cohorts. The patients with tumors of squamous histology in Cohort 1 help support our decision to initiate the AK112-306 Phase III clinical trial comparing ivonescimab against tislelizumab plus chemotherapy; the patients in Cohort 2 supported our earlier decision to enter into AK112-301 comparing ivonescimab plus chemotherapy against chemotherapy alone. * Confirmed responses for patients with at least one post-baseline scan; SQ-NSCLC n=60; EGFR-TKI n=19 ** NE – Not Established For Cohort 1, the frequency of treatment-emergent adverse events (TEAEs) leading to discontinuation of ivonescimab was 11%; there were no treatment-related adverse events (TRAEs) leading to the death of a patient. The most frequent treatment-emergent adverse events were anemia, decreased neutrophil counts, and decreased white-blood cell counts. In Cohort 2, ivonescimab had an acceptable safety profile. There were no TRAEs leading to permanent discontinuation of therapy or patient death. Key Near-Term Milestones of Ivonescimab: For the NDA for ivonescimab based on AK112-301, a decision from the Chinese Center for Drug Evaluation (CDE) is expected in Q2 2024, along with a read-out of topline data from the study. Ivonescimab is expected to become the world's first bispecific drug combining immunotherapy and anti-angiogenesis. Phase III data readout of ivonescimab monotherapy versus pembrolizumab monotherapy as first-line treatment for NSCLC patients with positive PD-L1 expression is expected in Q2 2024. Based on this data, the Company will submit an NDA for this indication as appropriate. Phase III enrollment completion of ivonescimab in combination with chemotherapy versus tislelizumab in combination with chemotherapy for first-line treatment of advanced or metastatic squamous NSCLC is expected in the second half of 2024. Phase III completion by Summit of the global enrollment of ivonescimab (AK112/SMT112) combined with chemotherapy in patients with EGFR-mutated, locally advanced or metastatic nsq-NSCLC who have progressed after treatment with a third-generation EGFR -TKI is expected in the second half of 2024. Potential initiation of Phase III clinical trials for ivonescimab in additional tumor types in 2024. Milestone Outlook for Cadonilimab (PD-1/CTLA-4 Bispecific) Following the Company's benchmark sales of cadonilimab, the world's first PD-1/CTLA-4 bispecific antibody, in 2023, the Company is poised to achieve additional important breakthroughs in 2024 that will significantly enhance clinical and commercial value. In January 2024, the NMPA accepted the sNDA for cadonilimab in combination with chemotherapy as first-line treatment for recurrent or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. NDA submission of cadonilimab + chemotherapy ± bevacizumab for first-line treatment for advanced cervical cancer is expected in Q1 2024. Phase III enrollment completion of cadonilimab for adjuvant treatment of hepatocellular carcinoma (HCC) is expected in Q4 2024. Phase III data readouts for first-line GC/GEJ cancer and first-line cervical cancer in 2024. Potential initiation of Phase III clinical trials for cadonilimab in additional tumor types in 2024. Other Potential Milestones for Oncology Products In terms of other significant oncology drug milestones, the Company is expected to reach several important milestones in 2024 to early 2025. Two bispecific antibodies, AK129 (PD-1/LAG3) and AK130 (TIGIT/TGFβ), are anticipated to enter Phase II, while ADC and neurodegenerative diseases candidates will undergo human clinical trials for the first time. Additionally, the CDE will also make a decision on the NDA for penpulimab for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). Finally, additional combination therapy data is anticipated to be announced. Key Near-Term Milestones of Non-Oncology Products NDA decision expected in 2024 on ebronucimab (PCSK9) for the treatment of hypercholesterolemia and heterozygous familial hypercholesterolemia. NDA decision expected in 2024 on ebdarokimab (IL-12/IL-23) for the treatment of moderate-to-severe psoriasis. Phase III enrollment completion of gumokimab (IL-17) for ankylosing spondylitis. Phase III data readout of gumokimab (IL-17) for Moderate-to-severe psoriasis. Based on this data, an NDA submission for gumokimab (IL-17) for the treatment of moderate-to-severe psoriasis. Potential initiation of a Phase III clinical trial for manfidokimab (IL-4R) for the treatment of moderate atopic dermatitis. Over the next five years, Akeso has high expectations of launching around 10 internally developed blockbuster drugs, both in China and worldwide, thereby achieving successful commercialization. Akeso has established and continuously advances its integrated and efficient system of discovery, development, production, and sales of its innovative drugs and pipeline candidates. About Akeso, Inc. Akeso (HKEX: 09926) is a commercial-stage biopharmaceutical company committed to discovering, developing, manufacturing, and commercializing innovative medicines that address significant medical needs globally. Since our inception, we have established a distinctive and 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 fundamental components, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode. Akeso is actively developing a diverse pipeline of over 30 innovative assets in areas such as cancer, autoimmune disease, inflammation, metabolic disease, and other therapeutic fields. Among these, 19 assets have entered the clinical stage, with 3 innovative drugs already approved, 13 Phase III studies ongoing. Utilizing its proprietary Tetrabody technology, Akeso has successfully developed the first-in-class PD-1/CTLA-4 bispecific antibody drug for the market. Additionally, the company has five other innovative bispecific antibody drugs in the clinical stage, including ivonescimab (PD-1/VEGF), PD-1/LAG-3, TIGIT/TGF-Beta, PD-1/CD73, and claudin18.2/CD47 bispecific antibodies. In June 2022, cadonilimab was approved by the NMPA and became the first commercialized bispecific IO drug globally. Another Akeso internally discovered and developed oncology product, penpulimab (a PD-1 antibody), was granted marketing approval in China in August 2021. In December 2022, Akeso entered into a collaboration and license agreement for up to US$5 billion with Summit Therapeutics to accelerate global development and commercialization of ivonescimab. In August, the NDA submission of ivonescimab was accepted by China's NMPA with priority review. Akeso is listed on the Main Board of the Stock Exchange of Hong Kong Limited. For more information, please visit and follow us on X (formerly Twitter) @AkesoInc Company Codes: HongKong:9926

Phase 3Phase 2NDALicense out/inClinical Result

30 Aug 2023

·www.prnewswire.com

Akeso Announced 2023 Interim Results: First Profit, Growing Sales of PD-1/CTLA-4 Bispecific Antibody and Priority Review of PD-1/VEGF

—During the reporting period, Akeso's revenue was RMB3,676.9 million, an increase of 2,154.4% from 2022H1; Akeso recorded a profit of RMB2,489.5 million. —RMB2,915.2 million was recognized by Akeso as license fee income during the reporting period due to the receipt of an upfront payment equivalent to US$500 million for Akeso's PD-1/VEGF bispecific antibody (ivonescimab) out-licensing agreement with Summit Therapeutics Inc. —The total product sales were RMB794.7 million. —The New Drug Application (NDA) of ivonescimab (PD-1/VEGF bispecific antibody) has been accepted and granted priority review by China NMPA; 2 NDAs for non-oncology segment products have been accepted: 2 indications for PCSK9 monoclonal antibody ebronucimab for the treatment of hypercholesterolemia, and IL-12/IL-23 monoclonal antibody ebdarokimab for the treatment of moderate-to-severe plaque psoriasis. HONG KONG, Aug. 29, 2023 /PRNewswire/ -- Akeso (9926. HK) released its 2023 interim performance: the Company achieved financial profitability for the first time in the first half of 2023, reaping success in new drug development, commercialization and globalization. Currently, Akeso has a total of 13 registrational Phase III clinical trials underway for 4 products, 3 drugs are approved. Cadonilimab (PD-1/CTLA-4) Patient enrollment was completed on the registrational Phase III clinical trials of PD-1/CTLA-4 bispecific antibody cadonilimab for the first-line treatment of advanced cervical cancer and gastric/gastroesophageal junction (G/GEJ) adenocarcinoma. The Phase III clinical trial of cadonilimab for the adjuvant treatment of hepatocellular carcinoma is undergoing efficiently. The clinical development for lung cancer, pancreatic cancer, esophageal squamous cancer and other major tumor diseases is also in orderly progress. In addition, 40+ Investigator initiated trials (IITs) for cadonilimab are underway. Ivonescimab(PD-1/VEGF) Ivonescimab(PD-1/VEGF) is Akeso's another bispecific antibody. 1 NDA of ivonescimab has been accepted and granted priority review by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). There are 4 Phase III clinical trials been initiated/are underway globally, of which 3 are Phase III clinical trials with PD-1 monoclonal antibody as the positive control drug, 2 are international multicenter Phase III clinical trials; 9 Phase II clinical trials for Ivonescimab have been conducted. 4 Phase III trials of ivonescimab: Patient enrollment was complete in the registrational Phase III clinical trial of ivonescimab versus pembrolizumab for the first-line treatment of PD-L1 positive NSCLC; Ivonescimab in combination with chemotherapy for patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC progressing on third-generation EGFR-TKI therapy (HARMONi / AK112-301) is enrolling patients; An international Phase III clinical trial of ivonescimab in combination with chemotherapy versus pembrolizumab in combination with chemotherapy as first-line treatment for metastatic squamous NSCLC has also been initiated； In China, a registrational Phase III clinical trial of ivonescimab in combination with chemotherapy versus tislelizumab in combination with chemotherapy as first-line treatment for advanced squamous NSCLC is underway. In December 2022, Akeso out-licensed Summit Therapeutics exclusive rights to ivonescimab (PD-1/VEGF) for the development and commercialization in the United States, Canada, Europe, and Japan in. Akeso is to receive a US$500 million upfront payment and the total potential deal value is up to US$5 billion including regulatory and commercial milestone payments. And Akeso will also receive a low double-digit percentage of royalties on net product sales of ivonescimab . Ivonescimab is engaged in many clinical trials for multiple types of lung cancer, gastric cancer, biliary tract cancer, pancreatic cancer, triple-negative breast cancer, head and neck squamous cell carcinomas, ovarian cancer and other gynecologic cancer, colorectal cancer, hepatocellular carcinoma, as well as other solid tumors. It is noteworthy that Akeso announced clinical progress and new products and therapies. In addition to the two bispecific antibodies mentioned above, AK129 (PD-1/LAG-3 bispecific antibody) and AK130 (TIGIT/TGF-β bispecific antibody) have already entered into the clinical trial, and AK131 (PD-1/CD73 bispecific antibody) and AK132 (Claudin18.2/CD47 bispecific antibody) are about to be approved for the clinical trial. Akeso also announced that a number of ADC drugs will soon enter clinical trials, including bispecific antibody ADC drugs. The clinical development of CD47, IL-4R, IL-17, CD73, TIGIT and other phase II and III target products is also in orderly progress. "We are very encouraged to see that our team has continued to achieve excellent results.In the first half of 2023 we had our best results since the company's inception in terms of financial performance, commercialization of new drugs, clinical development, and operation." Said Dr. Michelle Xia, founder, Chairwoman, CEO, and President of Akeso. "Such achievements do not come easily in a complex and difficult external situation. We would like to thank Akeso's team for their ten years of continual pursuit of excellence and improvement. We have put into practice the concept of new drug development driven by clinical value, maintain a forward-looking strategic layout and exceptional managerial efficiency, calmly respond to market changes, seize development opportunities, and grow on an ongoing basis. In the future, with successive approval of our innovative core products and their broad indications, and the further increase in our operational and managerial capabilities, Akeso will enter another period of rapid growth. We will continue to work diligently, professionally, and effectively to promote the more rapid, thorough, and wide-ranging translation of new drug innovations into global value, and we look forward to seeing the company enter a new stage of commercialization and sustained profitability in the coming years, to better deliver innovative clinical value to patients, and reward society and investors."Dr. Michelle Xia said. SOURCE Akeso, Inc.

Phase 3NDALicense out/inPhase 2

24 Aug 2023

·www.prnewswire.com

Akeso Announced NDA Acceptance of IL-12/lL-23 Monoclonal Antibody Ebdarokimab for Moderate-to-severe Plaque Psoriasis by China NMPA

HONG KONG, Aug. 24, 2023 /PRNewswire/ -- Akeso Inc. ("Akeso", the "Company"; 9926.HK), a commercial-stage biopharmaceutical company focused on developing and commercializing first-in-class and best-in-class innovative medicines globally, announced today that the New Drug Application (NDA) for its fully human IgG1 monoclonal antibody, ebdarokimab (IL-12/lL-23, AK101) has been accepted by the National Center for Drug Evaluation of the State Drug Administration of the People's Republic of China (NMPA CDE) for the treatment of adult patients with moderate-to-severe plaque-type psoriasis. Ebdarokimab is Akeso's 6th self-developed innovative drug that has been successfully approved for marketing/NDA submitted, the first patented domestic innovative drug targeting IL-12/IL-23. Ebdarokimab is also the company's 2nd innovative drug in non-oncology segment that has been filed for marketing. The NDA's acceptance of ebdarokimab reflects the strength of the company's R&D in the development of new non-oncology drugs in addition to oncology. A total of 5 clinical trials were conducted with ebdarokimab in patients with moderate-to-severe plaque psoriasis. Two pivotal Phase III clinical trials provided essential efficacy data for ebdarokimab in patients with moderate-to-severe plaque psoriasis at weeks 16 and 52, respectively. The results showed that ebdarokimab had significant efficacy in the treatment of moderate-to-severe plaque psoriasis at both 16 and 52 weeks with a favorable safety profile. Ebdarokimab was effective in improving patients' quality of life while improving skin lesions. As a number of competitive products from Akeso such as ebronucimab (PCSK9), ebdarokimab(IL-12/lL-23), gumokimab (IL-17), manfidokimab (IL-4R) and others are approved for the market consecutively, the Company's activity outside of the field of oncology will pave the way for commercialization. Akeso continues to integrate its beneficial resources to build its marketing capacity in non-oncology products with creativity and a strong market development capability, formulate targeted marketing strategies, in order for the non-oncology segment to become a powerful driver for the Company's overall successful growth. About Ebdarokimab (IL-12/lL-23 Monoclonal Antibody, AK101) Ebdarokimab is a novel fully human Interleukin-12/Interleukin-23 monoclonal antibody independently developed by Akeso. The pathogenesis of psoriasis is associated with an aberrant immune response. IL-12 and IL-23 are cytokines that are naturally produced during inflammation and immune reactions, sharing the common p40 subunit, where IL-12 induces Th1 cells (helper T cells 1) to proliferate and release interferon and TNF-α (tumor necrosis factor-α), and IL-23 induces Th17 cells (helper T cells 17) to proliferate and release IL-17 (interleukin-17), etc. These cytokines are crucial for inflammatory and immune responses. By targeting and binding to the p40 subunit of IL-12 and IL-23, and hampering the interaction of IL-12 and IL-23 with cell surface receptors, ebdarokimab reduces the release of cytokines such as interferon, TNF-alpha, IL-17 and other related cytokines from T-cells, and blocks their respective mediated cellular immune responses, thus achieving the objective of treating psoriasis by inhibiting the aberrant psoriasis immune response. About Akeso Inc. Akeso (HKEX: 09926) is a commercial-stage biopharmaceutical company committed to discovering, developing, manufacturing, and commercializing innovative medicines that address significant medical needs globally. Since our inception, we have established a distinctive and 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 fundamental components, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode. Akeso is internally working on a robust pipeline of over 30 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease, and other major therapeutic areas. 19 assets have entered the clinical stage and 3 innovative drugs have been approved. Leveraging in-house developed bispecific platform technology ("Tetrabody technology"), the company has advanced four potential first-in-class bispecific antibody drugs into market or clinical development, including cadonilimab (PD-1/CTLA-4), ivonescimab (PD-1/VEGF), PD-1/LAG-3, and TIGIT/TGF-Beta bispecific antibodies. In June 2022, cadonilimab was approved by the NMPA and became the first commercialized PD-1 based bispecific drug globally. Another Akeso internally discovered and developed oncology product, penpulimab (a PD-1 antibody), was granted marketing approval in China in August 2021. In December 2022, Akeso entered into a collaboration and license agreement for up to US$5 billion with Summit Therapeutics to accelerate global development and commercialization of ivonescimab. In August, the NDA submission of ivonescimab was accepted by China's NMPA. Akeso is listed on the Main Board of the Stock Exchange of Hong Kong Limited. SOURCE Akeso, Inc.

License out/inPhase 3Drug ApprovalNDAClinical Result

100 Deals associated with Ebdarokimab

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Plaque psoriasis	NDA/BLA	CN	Akeso Biopharma Co., Ltd.	23 Aug 2023
Psoriasis vulgaris	Phase 3	CN	Akeso Biopharma Co., Ltd.	29 Nov 2021
Colitis, Ulcerative	Phase 2	CN	Akeso Biopharma Co., Ltd.	30 Jan 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05509361 (AK101-303, Company_Website) Manual	Phase 3	Psoriasis	950	依若奇（AK101） (第1组)	zfqhchdxto(oumwnvozhk) = cepbasrmci elzvxiexhj (fveqywdkjx ) View more	Positive	02 Oct 2024
				依若奇（AK101） (对照药16周治疗后，第16周切换到依若奇治疗)	zfqhchdxto(oumwnvozhk) = hguxcamtzx elzvxiexhj (fveqywdkjx ) View more
Phase III Clinical Study (EADV2023)	Phase 3	Plaque psoriasis IL-12 \| IL-23	450	AK101 135mg	xccguxhzei(odnnyxfoxh) = No adverse events with special interest ( AESI ) and no AEs leading to death of subjects in this study rwplvdrems (jwgropkxyk ) View more	Positive	11 Oct 2023
				Placebo

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