ebdarokimab (AK101) / Akesobio - LARVOL DELTA

Akeso's Ebdarokimab ( IL - 12/IL - 23 Dual - Targeted Monoclonal Antibody) Approved in China for Moderate - to - Severe Plaque Psoriasis (PRNewswire) - "Akeso, Inc...has received marketing approval from the National Medical Products Administration (NMPA) for the treatment of moderate-to-severe plaque psoriasis in adult patients....Two pivotal Phase III studies demonstrated ebdarokimab's efficacy and safety at both 16 weeks and 52 weeks in these patients."

China approval • Psoriasis

Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=330 | Completed | Sponsor: Akeso | Phase classification: P2b ➔ P2

Phase classification • Dermatology • Immunology • Psoriasis

…blockbuster new drugs expected to be approved for marketing in China in 2025 [Google translation] (Sohu.com) - "Kangfang Biopharma's ebdarokimab (AK101) : This is a monoclonal antibody targeting IL-12/IL-23, used to treat moderate to severe plaque psoriasis. The drug's marketing application has been accepted by the CDE and is expected to be approved in the first quarter of 2025....Hengrui's ivarmacitinib (JAK1 inhibitor) : This is an oral JAK1 inhibitor used to treat moderate to severe active rheumatoid arthritis and other autoimmune diseases. The drug's marketing application has been accepted by the CDE and is expected to be approved in the first to second quarter of 2025."

China approval • Psoriasis • Rheumatoid Arthritis

Long-term Safety and Efficacy of Ebdarokimab in Patients with Moderate to Severe Plaque Psoriasis: Results from a Single Arm, Open Label, Multicenter Phase III Clinical Study (EADV 2024) - "AK101 was generally safe and well tolerated, with good improvement in PASI 75 and sPGA0/1 response in Chinese subjects with moderate to severe plaque psoriasis."

Clinical • P3 data • Dermatology • Immunology • Inflammation • Psoriasis • IL12A • IL23A

Prioritizing drug targets in systemic lupus erythematosus from a genetic perspective: a druggable genome-wide Mendelian randomization study. (PubMed, Clin Rheumatol) - "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."

Journal • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • BLK • HSPA1A • IL12A • NEU1

Open Label Study to Evaluate the Safety and Efficacy of AK101 Injection Subcutaneously in Subjects With Psoriasis (clinicaltrials.gov) - P3 | N=950 | Completed | Sponsor: Akeso | Recruiting ➔ Completed | Trial completion date: Jan 2023 ➔ Nov 2023 | Trial primary completion date: Jan 2023 ➔ Nov 2023

Trial completion • Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis

Efficacy and safety of AK101 in Patients with Moderate to Severe Plaque Psoriasis: Results from a Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study (EADV 2023) - "AK101 was generally safe and able to improve PASI and sPGA0/1 response, as well as DLQI score in Chinese subjects with moderate to severe plaque psoriasis. There was no significant difference in the incidence of AEs between the AK101 group and the placebo group."

Clinical • P3 data • Dermatology • Dyslipidemia • Immunology • Infectious Disease • Inflammation • Psoriasis • Respiratory Diseases • IL12A • IL23A

Akeso Announced NDA Acceptance of IL-12/lL-23 Monoclonal Antibody Ebdarokimab for Moderate-to-severe Plaque Psoriasis by China NMPA (PRNewswire) - "Akeso Inc...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....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."

Non-US regulatory • Immunology • Psoriasis

Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2b | N=330 | Completed | Sponsor: Akeso | Unknown status ➔ Completed | Trial completion date: Jul 2022 ➔ Mar 2022

Trial completion • Trial completion date • Dermatology • Immunology • Psoriasis

A Phase 3 Study of Efficacy and Safety of AK101 in Subjects With Psoriasis (clinicaltrials.gov) - P3 | N=452 | Completed | Sponsor: Akeso | Active, not recruiting ➔ Completed | Trial completion date: Feb 2022 ➔ Sep 2022 | Trial primary completion date: Feb 2022 ➔ Sep 2022

Trial completion • Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis

A Phase I Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Immunogenicity of Ebdarokimab in Patients with Moderate to Severe Plaque Psoriasis: Withdrawn (ACR Convergence 2022) - No abstract available

Clinical • P1 data • PK/PD data • Dermatology • Immunology • Psoriasis

Open Label Study to Evaluate the Safety and Efficacy of AK101 Injection Subcutaneously in Subjects With Psoriasis (clinicaltrials.gov) - P3 | N=950 | Recruiting | Sponsor: Akeso

New P3 trial • Dermatology • Immunology • Psoriasis

Akeso Reported 2021 Annual Results (PRNewswire) - "In non-oncology therapeutic area, AK101 (IL12/23) entered into Phase III clinical study for the treatment of moderate-to-severe plaque psoriasis."

Trial status • Immunology • Psoriasis

A Phase 3 Study of Efficacy and Safety of AK101 in Subjects With Psoriasis (clinicaltrials.gov) - P3; N=450; Active, not recruiting; Sponsor: Akeso

Clinical • New P3 trial • Dermatology • Immunology • Psoriasis

Akeso gets approval for AK101 investigational New Drug Application in China (Reuters) - “Announces approval for AK101 Investigational New Drug Application for ulcerative colitis in China”

Non-US regulatory • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2b; N=280; Not yet recruiting; Sponsor: Akeso

Clinical • New P2b trial

A Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P1/2; N=96; Completed; Sponsor: Akeso

Clinical • New P1/2 trial