IMG-004 / Inmagene, Hutchmed - LARVOL DELTA

IMG-004, a selective noncovalent reversible Bruton's tyrosine kinase inhibitor, demonstrated potent pharmacodynamic effects (EADV 2024) - "IMG-004 bound to BTK with a prolonged residence time of 34.75 h, compared with 11.01 h shown by an in-house made fenebrutinib analog. IMG-004, a unique noncovalent reversible BTK inihibitor, demonstrated potent BTK inhibition in vitro and protective efficacy in a cGvHD model in vivo. IMG-004 is a promising potential therapeutic agent for chronic autoimmune diseases. Table 1."

IO biomarker • PK/PD data • Chronic Graft versus Host Disease • Chronic Spontaneous Urticaria • Dermatology • Graft versus Host Disease • Hidradenitis Suppurativa • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • Urticaria • CD63 • CD69

Inmagene Announces Positive Topline Results of a Multiple Ascending Dose (MAD) Study of IMG-004, a Non-covalent Reversible BTK Inhibitor with Once Daily Dosing Potential (GlobeNewswire) - P1 | N=72 | NCT05349097 | Sponsor: Inmagene LLC | "Inmagene Biopharmaceuticals...today announced positive topline results from the multiple ascending dose (MAD) portion of its randomized, double-blind, placebo-controlled Phase 1 study of IMG-004, a potent, non-covalent, reversible, and brain permeable Bruton’s tyrosine kinase (BTK) inhibitor....All three doses tested in this study provided a steady-state exposure over the entire dosing interval which achieved at least 90% maximal inhibitory concentration (IC90), estimated based on PK/PD modeling. Taken together, the data supports a potential therapeutic dose regimen of 50 mg QD for IMG-004, with a wide safety margin relative to the highest tested 300 mg QD dose that was well-tolerated."

P1 data • Immunology

Study to Evaluate IMG-004 in Healthy Participants (clinicaltrials.gov) - P1 | N=72 | Completed | Sponsor: Inmagene LLC | Recruiting ➔ Completed | Trial completion date: Nov 2024 ➔ May 2024

Trial completion • Trial completion date

Study to Evaluate IMG-004 in Healthy Participants (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Inmagene LLC | Completed ➔ Recruiting | N=40 ➔ 72 | Trial completion date: Jan 2023 ➔ Nov 2024 | Trial primary completion date: Jan 2023 ➔ May 2024

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date

HUTCHMED Announces that Inmagene Exercises Option to License Two Drug Candidates as Part of Strategic Partnership (GlobeNewswire) - "HUTCHMED (China) Limited...today announced that, Inmagene Biopharmaceuticals ('Inmagene') has exercised options to license two drug candidates discovered by HUTCHMED, IMG-007 and IMG-004 (the 'Options') pursuant to the terms of the strategic partnership announced on January 11, 2021. Following the exercise of the Options and subject to receipt by HUTCHMED of ordinary shares representing approximately 7.5% of shares (fully diluted) in Inmagene, Inmagene will be granted an exclusive license to further develop, manufacture and commercialize these two drug candidates worldwide."

Licensing / partnership • Asthma • Atopic Dermatitis • CNS Disorders • Graft versus Host Disease • Immunology • Multiple Sclerosis • Rheumatoid Arthritis

Safety, Pharmacokinetics, and Pharmacodynamics of IMG-004, a Selective Reversible Bruton's Tyrosine Kinase Inhibitor in Healthy Participants (EADV 2023) - "IMG-004 was well tolerated at doses up to 600 mg. The long half-life and sustained PD effect support further exploration of efficient and convenient dose regimens in future clinical development. IMG-004 represents a promising potential therapeutic agent for the treatment of autoimmune diseases."

Clinical • PK/PD data • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria • CD63

IMG-004 demonstrated extended half-life and durable pharmacodynamic characteristics in a Phase 1 study (PRNewswire) - P1 | N=40 | NCT05349097 | Sponsor: Inmagene Biopharmaceuticals | "Inmagene Biopharmaceuticals ('Inmagene') today announced positive topline results from a Phase 1 study evaluating IMG-004 in healthy participants...Inmagene is developing the drug candidate to potentially treat immunological diseases...IMG-004 was well tolerated, with no dose-limiting or serious adverse events. It was rapidly absorbed following the oral administration with peak concentrations occurring around 2 hours post-treatment and was eliminated with a terminal half-life ranging from 26 to 37 hours."

PK/PD data • Immunology

Study to Evaluate IMG-004 in Healthy Participants (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Inmagene Biopharmaceuticals | Recruiting ➔ Completed | N=74 ➔ 40 | Trial completion date: Jul 2023 ➔ Dec 2022 | Trial primary completion date: Mar 2023 ➔ Dec 2022

Enrollment change • Trial completion • Trial completion date • Trial primary completion date

Study to Evaluate IMG-004 in Healthy Participants (clinicaltrials.gov) - P1 | N=74 | Recruiting | Sponsor: Inmagene Biopharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open

Study to Evaluate IMG-004 in Healthy Participants (clinicaltrials.gov) - P1 | N=74 | Not yet recruiting | Sponsor: Inmagene Biopharmaceuticals

New P1 trial