First Patient Dosed in IMG-007 Atopic Dermatitis Study

The first patient has been dosed in a proof-of-concept study examining the efficacy, safety, and pharmacokinetics of Inmagene Biopharmaceuticals’ IMG-007, an OX40 receptor-binding humanized IgG1 monoclonal antibody (mAb), in adult patients with moderate to severe atopic dermatitis (AD).¹

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The phase 1b/2a, double-arm, open label study (NCT05984784) will examine the effects of IMG-007 in varying doses and consist of a 5-week screening period, a 12-week treatment period, and a 12-week follow-up period.²

Patients will be between the ages of 18 to 74 years of age with a moderate to severe AD diagnosis. Additionally, all participants must present with a documented history of inadequate response or lack of tolerability to 1 or more topical treatment options. Patients who are pregnant, lactating, or whohave an active infection, tuberculosis, pruritic skin condition, or a condition which may impact the safety of the treatment, are excluded from participation.²

Patients will be assigned via sequential assignment to 1 of 2 treatment arms, including a 300 mg or 600 mg dose of IMG-007, both to be administered intravenously 3 times over a 4-week period. Researchers will evaluate adverse events, pharmacokinetic characterization (via central compartment clearance and volume), and efficacy via the Eczema Area and Severity Index.²

At this time, it is estimated that the study will include 24 enrolled participants and conclude in May 2024.²

A previous study of the drug involving a single ascending dose in adult patients showed that IMG-007 possesses a half-life which exceeds that of the average conventional IgG. Target serum concentration was maintained from 12 to 18 weeks post-treatment, indicating the potential for extended “drug holidays,” and the drug was well-tolerated among study participants.²

"IMG-007 represents an investigational drug with multiple potential indications," said Yufang Lu, MD, PhD, and chief medical officer of Inmagene in a press release from the company.¹ "We are excited to begin this trial of IMG-007 in AD patients, following favorable safety and highly differentiated pharmacokinetic results of the earlier trial. We are continuing our evaluations of IMG-007's potential in other diseases where OX40 signaling pathway plays an important pathogenic role."

References

1. Inmagene. Inmagene’s OX40 MAB, with an extended half-life and silenced ADCC, enters POC study in atopic dermatitis. PR Newswire: press release distribution, targeting, monitoring and marketing. August 15, 2023. Accessed August 21, 2023. https://www.prnewswire.com/news-releases/inmagenes-ox40-mab-with-an-extended-half-life-and-silenced-adcc-enters-poc-study-in-atopic-dermatitis-301901200.html.
2. CTG Labs - NCBI. Accessed August 21, 2023. https://www.clinicaltrials.gov/study/NCT05984784?term=inmagene+IMG-007&rank=1.