manfidokimab (AK120) / Akesobio - LARVOL DELTA

A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AK120 in Subjects With Atopic Dermatitis (clinicaltrials.gov) - P1/2 | N=427 | Completed | Sponsor: Akeso | Recruiting ➔ Completed | Trial completion date: Oct 2024 ➔ Jun 2024 | Trial primary completion date: Sep 2024 ➔ Jun 2024

Trial completion • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=79 | Terminated | Sponsor: Akesobio Australia Pty Ltd | Recruiting ➔ Terminated; Clinical study and development strategy adjustment

Trial termination • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - P3 | N=198 | Not yet recruiting | Sponsor: Akeso

New P3 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis (AD) (clinicaltrials.gov) - P2 | N=24 | Not yet recruiting | Sponsor: Akeso

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Evaluate the Efficacy and Safety of AK120 in Subjects With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=450 | Recruiting | Sponsor: Akeso

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Evaluate the Safety and Efficacy of AK120 in Subjects With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=180 | Completed | Sponsor: Akeso | Not yet recruiting ➔ Completed | Trial completion date: May 2025 ➔ Nov 2024

Trial completion • Trial completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Phase III Study to Evaluate the Efficacy and Safety of AK120 in Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P3 | N=420 | Recruiting | Sponsor: Akeso

New P3 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Phase II Study to Evaluate the Safety and Efficacy of AK120 in Subjects With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=180 | Not yet recruiting | Sponsor: Akeso

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Safety, Pharmacokinetics, and Pharmacodynamics of AK120 in subjects with Moderate- to- Severe Atopic Dermatitis:Results from a Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study (EADV 2023) - "AK120 administered as a multiple dose via SC injection ranged from 75 mg to 600 mg were safe and well tolerated in AD subjects. Mild to moderate drug accumulation was observed in 75 mg QW,150 mg QW and 300 mg QW dose groups."

Clinical • P1 data • PK/PD data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Infectious Disease • Pain • IL13 • IL4 • IL4R

A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AK120 in Subjects With Atopic Dermatitis (clinicaltrials.gov) - P1/2 | N=416 | Recruiting | Sponsor: Akeso

New P1/2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Safety, Pharmacokinetics and Preliminary Efficacy of IL4-Rα Monoclonal Antibody AK120 in Both Healthy and Atopic Dermatitis Subjects: A Phase I, Randomized, Two-Part, Double-Blind, Placebo-Controlled, Dose-Escalation, First-In-Human Clinical Study. (PubMed, Dermatol Ther (Heidelb)) - P1 | "AK120 exhibited an acceptable safety profile in healthy and AD subjects, and showed preliminary efficacy. These findings support the continued investigation of AK120 for treating AD."

Journal • P1 data • PK/PD data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • IL13 • IL4 • IL4R

A Study to Evaluate the Efficacy and Safety of AK120 in the Treatment of Subjects With Moderate-to-severe Asthma (clinicaltrials.gov) - P2 | N=1 | Terminated | Sponsor: Akeso | N=180 ➔ 1 | Trial completion date: Apr 2023 ➔ Aug 2022 | Not yet recruiting ➔ Terminated; The clinical development strategy has been changed

Enrollment change • Trial completion date • Trial termination • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A phase 1, randomized, double-blind, placebo-controlled, dose-escalation, first-in- human study to evaluate the safety, tolerability, PK/PD of AK120 in healthy subjects (EADV 2022) - No abstract available

Clinical • P1 data • PK/PD data

A Study of AK120 (IL-4Rα) in Healthy Subjects and Subjects With Moderate- to- Severe Atopic Dermatitis (clinicaltrials.gov) - P1 | N=80 | Completed | Sponsor: Akesobio Australia Pty Ltd | Recruiting ➔ Completed | Trial completion date: Jul 2021 ➔ Oct 2021 | Trial primary completion date: Apr 2021 ➔ Oct 2021

Trial completion • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=105 | Recruiting | Sponsor: Akesobio Australia Pty Ltd | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2022 ➔ Jan 2024 | Trial primary completion date: Nov 2022 ➔ Oct 2023

Enrollment open • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Evaluate the Efficacy and Safety of AK120 in the Treatment of Subjects With Moderate-to-severe Asthma (clinicaltrials.gov) - P2; N=180; Not yet recruiting; Sponsor: Akeso

Clinical • New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Akeso is Rapidly Advancing The Phase II Clinical Trial of IL-4R Monoclonal Antibody (AK120) for the Treatment of Atopic Dermatitis and Asthma (PRNewswire) - "Akeso, Inc...announces that...IL-4R monoclonal antibody (AK120), was approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of the People's Republic of China to initiate a phase II clinical trial for the treatment of moderate-to-severe asthma. Meanwhile, the first patient enrollment for the global phase II clinical trial of AK120 for the treatment of moderate-to-severe atopic dermatitis in the first research center in the United States has been completed and the trial is progressing rapidly."

New P2 trial • Trial status • Asthma • Atopic Dermatitis • Immunology

Kangfang Bio-B (09926.HK): AK120 was approved to carry out a global phase II clinical study for the treatment of moderate to severe atopic dermatitis [Google translation] (Finet Group) - P1, N=70; NCT04256174; Sponsor: Akesobio Australia Pty Ltd; "Kangfang Bio-B...announced...(R&D code: AK120) has been approved by the US Food and Drug Administration...phase II clinical study...atopic dermatitis. This is a multi-center, randomized, double-blind, placebo-controlled, parallel grouping, dose exploration phase II clinical study to evaluate the efficacy and safety of AK120 in adult subjects with moderate to severe atopic dermatitis....AK120 has completed a single-dose escalation phase Ia clinical study in healthy subjects and a multi-dose escalation phase Ib clinical study for the treatment of atopic dermatitis in New Zealand and Australia....AK120 is safe and well tolerated when administered subcutaneously in a single dose of up to 600 mg in healthy adult subjects....AK120 also shows good safety and tolerability at a dose of up to 300 mg administered subcutaneously per week."

New P2 trial • P1 data • Atopic Dermatitis • Immunology

Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P2; N=105; Not yet recruiting; Sponsor: Akesobio Australia Pty Ltd

Clinical • New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Osaikang Vice Chairman and Director Zhao Jun resigns. Eli Lilly’s Erbitux new drug regimen is approved by the US FDA [Google translation] (Sina Corp) - "On April 8, the CDE official website showed that Kangfang Biologics Class 1 new drug AK120 injection was approved for clinical use, and the indication is moderate to severe atopic dermatitis. This is the first time that the drug has been approved for clinical use in China."

New trial • Atopic Dermatitis • Immunology

Kangfang Bio-IL-4R monoclonal antibody (AK120) phase Ib clinical trial completed the first patient enrollment [Google translation] (Sina Corp) - "Kangfang Bio-B...announced that the company’s self-developed IL-4R monoclonal antibody injection (R&D code: AK120) was launched in New Zealand and Australia for the treatment of moderate to severe atopic. The first patient was enrolled in the phase Ib clinical trial...Phase Ia clinical study in healthy subjects has climbed to the highest dose of 600 mg. The results of the study show that AK120 is well tolerated after a single subcutaneous injection....Intended to be used to treat allergic diseases such as atopic dermatitis and asthma."

P1 data • Trial status • Asthma • Atopic Dermatitis • Immunology

A Study of AK120 (IL-4Rα) in Healthy Subjects and Subjects With Moderate- to- Severe Atopic Dermatitis (clinicaltrials.gov) - P1; N=70; Recruiting; Sponsor: Akesobio Australia Pty Ltd; N=40 ➔ 70

Clinical • Enrollment change • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • CCL7

A Study of AK120 (IL-4Rα) in Healthy Subjects (clinicaltrials.gov) - P1; N=40; Recruiting; Sponsor: Akesobio Australia Pty Ltd; Not yet recruiting ➔ Recruiting; Initiation date: Feb 2020 ➔ Jun 2020

Clinical • Enrollment open • Trial initiation date • Atopic Dermatitis • Dermatitis • Dermatology • Dermatopathology • Immunology

A Study of AK120 in Healthy Subjects (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Akesobio Australia Pty Ltd

Clinical • New P1 trial